## Protocol Section
### Identification Module
**NCT ID:** NCT01806779

**Acronym:** ConNic5

**Brief Title:** Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers

**Official Title:** Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers

#### Organization Study ID Info
**ID:** Pro00042699
#### Organization
**Class:** OTHER
**Full Name:** Duke University
#### Secondary ID Infos
**ID:** 1P50DA027840-01A1
**Link:** https://reporter.nih.gov/quickSearch/1P50DA027840-01A1
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2015-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-01-18

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-12-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2015-10-08

**Type:** ESTIMATED

**Results First Submit Date:** 2015-09-03

**Results First Submit QC Date:** 2015-09-03

#### Start Date
**Date:** 2013-03

**Status Verified Date:** 2015-10

#### Study First Post Date
**Date:** 2013-03-07
**Type:** ESTIMATED
**Study First Submit Date:** 2013-03-06
**Study First Submit QC Date:** 2013-03-06
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute on Drug Abuse (NIDA)

**Class:** INDUSTRY

**Name:** Philip Morris USA, Inc.

#### Lead Sponsor

**Class:** OTHER

**Name:** Duke University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Previous results from the investigators' Center have shown that combination treatment with Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to replicate these findings with this study.

### Conditions Module

**Conditions:**

- Nicotine Dependence

**Keywords:**

- Nicotine addiction

- Cigarette smoking

- Smoking cessation

- Zyban

- Chantix

- Nicotine patches

- varenicline

- bupropion

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 376

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.

**Intervention Names:**

- Drug: Chantix

- Drug: Nicotine patches

**Label:** Chantix

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.

**Intervention Names:**

- Drug: Chantix

- Drug: Zyban

- Drug: Nicotine patches

**Label:** Chantix + Zyban

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Chantix

- Chantix + Zyban

**Name:** Chantix

**Other Names:**

- Varenicline

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Chantix + Zyban

**Name:** Zyban

**Other Names:**

- Bupropion

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Chantix

- Chantix + Zyban

**Description:** All participants will receive 21 mg/24 h dose nicotine (nic.) patches for 1 week.

**Name:** Nicotine patches

**Other Names:**

- NRT

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** Withdrawal symptoms will be assessed by questionnaire on Quit Day, Week 1, Week 3, Week 7 and Week 11 post target quit date and 6 months post quit Follow-Up (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.

**Measure:** Change in Smoking Withdrawal Symptoms

**Time Frame:** Quit Day and 1 week, 3 weeks, 7 Weeks, 11 Weeks and 6 months post Quit Day

#### Primary Outcomes

**Description:** This will be determined by a composite of self-report at the 11-week study visit of no smoking between the 8-week and 11-week visits and expired air carbon monoxide (CO) \<10 ppm (measured at the 11-week study visit). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.

**Measure:** Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits

**Time Frame:** Period between 8-week and 11-week visits post target Quit Day

#### Secondary Outcomes

**Description:** This will be determined by a self-report of no smoking for the previous seven days when called for 6-month follow-up confirmed by expired air CO.

**Measure:** Number of Participants Completing Seven-day Point Abstinence From Smoking at 6 Months Post Quit Day

**Time Frame:** 6 months post Quit Day

**Description:** This will be determined by a composite of self-report of no smoking between study visits at the 1-week, 3-week, 7-week and 11-week post Quit Day study visits and expired air carbon monoxide (CO) \<10 ppm (measured at those study visits). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.

**Measure:** Number of Participants Completing Continuous Abstinence From Smoking Between Quit Day and 11-week Post Quit Day Visit

**Time Frame:** Quit Day to 11-week post Quit Day study visit

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Have no known serious medical conditions;
* Male;
* Are 18-65 years old;
* Smoke an average of at least 10 cigarettes per day;
* Have smoked at least one cumulative year;
* Have an expired air carbon monoxide (CO) reading of at least 10ppm;
* Able to read and understand English;
* Express a desire to quit smoking in the next thirty days.

Potential subjects must agree to use acceptable contraception.

Potential subjects must agree to avoid the following:

* participation in any other nicotine-related modification strategy outside of this protocol;
* use of tobacco products other than cigarettes, including pipe tobacco, cigars, e-cigarettes, snuff, and chewing tobacco;
* use of experimental (investigational) drugs or devices;
* use of illegal drugs;
* use of opiate medications.

Exclusion Criteria:

* Hypertension;
* Hypotension with symptoms;
* Coronary heart disease;
* Lifetime history of heart attack;
* Cardiac rhythm disorder (irregular heart rhythm);
* Chest pains (unless history, exam, and electrocardiogram (ECG) clearly indicate a non-cardiac source);
* Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
* History of skin allergy;
* Active skin disorder (e.g., psoriasis) within the last five years;
* Liver or kidney disorder (except kidney stones, gallstones);
* Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
* Active ulcers in the past 30 days;
* Currently symptomatic lung disorder/disease (including but not limited to Chronic obstructive pulmonary disease (COPD), emphysema, and asthma);
* Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder);
* Migraine headaches that occur more frequently than once per week;
* Recent, unexplained fainting spells;
* Problems giving blood samples;
* Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%);
* Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
* Other major medical condition;
* Current psychiatric disease (with the exception of anxiety disorders, Obsessive Compulsive Disorder (OCD) and ADHD);
* Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
* Current depression;
* Bulimia or anorexia;
* Use of opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed) within the past 14 days;
* Smoking more than one cigar a month.
* Alcohol abuse;
* Significant adverse reaction to nicotine patches, bupropion / Wellbutrin / Zyban or Chantix / varenicline in the past.
* Current participation or recent participation (in the past 30 days) in another smoking study at our Center or another research facility.
* Current participation in another research study.

Use (within the past 30 days) of:

* Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol (THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (PCP), Benzodiazepines, or Barbiturates),
* Experimental (investigational) drugs;
* Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
* Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes;
* Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine replacement therapy or any other smoking cessation aid.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Charlotte

**Country:** United States

**Facility:** Duke Center for Smoking Cessation

**State:** North Carolina

**Zip:** 28210

**Location 2:**

**City:** Durham

**Country:** United States

**Facility:** Duke Center for Smoking Cessation

**State:** North Carolina

**Zip:** 27705

**Location 3:**

**City:** Raleigh

**Country:** United States

**Facility:** Duke Center for Smoking Cessation

**State:** North Carolina

**Zip:** 27609

**Location 4:**

**City:** Winston-Salem

**Country:** United States

**Facility:** Duke Center for Smoking Cessation

**State:** North Carolina

**Zip:** 27103

#### Overall Officials

**Official 1:**

**Affiliation:** Duke University

**Name:** Jed E Rose, Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Rose JE, Behm FM. Combination Varenicline/Bupropion Treatment Benefits Highly Dependent Smokers in an Adaptive Smoking Cessation Paradigm. Nicotine Tob Res. 2017 Aug 1;19(8):999-1002. doi: 10.1093/ntr/ntw283.

**PMID:** 29054128

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019966

- Term: Substance-Related Disorders

- ID: D000064419

- Term: Chemically-Induced Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC25

- Name: Substance Related Disorders

### Condition Browse Module - Browse Leaves

- ID: M19100

- Name: Behavior, Addictive

- Relevance: LOW

- As Found: Unknown

- ID: M16785

- Name: Tobacco Use Disorder

- Relevance: HIGH

- As Found: Nicotine Dependence

- ID: M21837

- Name: Substance-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014029

- Term: Tobacco Use Disorder

### Intervention Browse Module - Ancestors

- ID: D000005731

- Term: Ganglionic Stimulants

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018722

- Term: Nicotinic Agonists

- ID: D000018679

- Term: Cholinergic Agonists

- ID: D000018678

- Term: Cholinergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000018687

- Term: Antidepressive Agents, Second-Generation

- ID: D000000928

- Term: Antidepressive Agents

- ID: D000011619

- Term: Psychotropic Drugs

- ID: D000018765

- Term: Dopamine Uptake Inhibitors

- ID: D000014179

- Term: Neurotransmitter Uptake Inhibitors

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000015259

- Term: Dopamine Agents

- ID: D000065690

- Term: Cytochrome P-450 CYP2D6 Inhibitors

- ID: D000065607

- Term: Cytochrome P-450 Enzyme Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CNSSti

- Name: Central Nervous System Stimulants

- Abbrev: CaAg

- Name: Cardiotonic Agents

### Intervention Browse Module - Browse Leaves

- ID: M19013

- Name: Bupropion

- Relevance: HIGH

- As Found: 10 days

- ID: M12478

- Name: Nicotine

- Relevance: HIGH

- As Found: Prior to

- ID: M278

- Name: Varenicline

- Relevance: HIGH

- As Found: Option

- ID: M4029

- Name: Central Nervous System Stimulants

- Relevance: LOW

- As Found: Unknown

- ID: M20796

- Name: Nicotinic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20758

- Name: Cholinergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4247

- Name: Antidepressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

- ID: M7473

- Name: Dopamine

- Relevance: LOW

- As Found: Unknown

- ID: M20832

- Name: Dopamine Uptake Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M17962

- Name: Dopamine Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M30537

- Name: Cytochrome P-450 Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: T482

- Name: Varenicline

- Relevance: HIGH

- As Found: Option

### Intervention Browse Module - Meshes

- ID: D000016642

- Term: Bupropion

- ID: D000009538

- Term: Nicotine

- ID: D000068580

- Term: Varenicline

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.

#### Event Groups

**Group ID:** EG000

**Title:** Chantix

**Description:** For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.

Chantix

Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.

**ID:** EG000

**Other Num Affected:** 39

**Other Num at Risk:** 87

**Serious Number Affected:** 3

**Serious Number At Risk:** 90

**Title:** Chantix

**Group ID:** EG001

**Title:** Chantix + Zyban

**Description:** For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.

Chantix

Zyban

Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.

**ID:** EG001

**Other Num Affected:** 53

**Other Num at Risk:** 83

**Serious Number Affected:** 2

**Serious Number At Risk:** 84

**Title:** Chantix + Zyban

**Group ID:** EG002

**Title:** Nicotine Patch

**Description:** All participants will receive Nicotine Replacement Therapy (NRT) in the form of 21 mg/24 h dose nicotine patches for 1 week prior to randomization to treatment with Chantix alone or Chantix + Zyban.

**ID:** EG002

**Other Num Affected:** 57

**Other Num at Risk:** 176

**Serious Number At Risk:** 197

**Title:** Nicotine Patch

**Frequency Threshold:** 5

#### Other Events

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Excessive Sweating

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Change in Taste

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Dry Mouth

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Thirst

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Joint/Muscle/Back Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Irritability

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Vivid Dreams

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Decreased Libido

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Itching/Burning at Patch Site

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Allergic Reaction to Chantix or Zyban

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 90

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 84

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 197

**Term:** Non-cardiac Chest Pain & Right Ventricular Hypertrophy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 90

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 84

**Group ID:** EG002

**Num At Risk:** 197

**Term:** Jaw & upper extremity fracture due to an accident

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 90

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 84

**Group ID:** EG002

**Num At Risk:** 197

**Term:** COPD and reactive airway disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 90

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 84

**Group ID:** EG002

**Num At Risk:** 197

**Term:** Left sided weakness, headache, blurred vision

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 90

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 84

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 197

**Time Frame:** Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 90

**Group ID:** BG001

**Value:** 84

**Group ID:** BG002

**Value:** 174

**Units:** Participants

### Group

**ID:** BG000

**Title:** Chantix

**Description:** For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.

Chantix

Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.

### Group

**ID:** BG001

**Title:** Chantix + Zyban

**Description:** For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.

Chantix

Zyban

Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 90

#### Measurement

**Group ID:** BG001

**Value:** 84

#### Measurement

**Group ID:** BG002

**Value:** 174

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 11.381

**Value:** 44.75

#### Measurement

**Group ID:** BG001

**Spread:** 10.562

**Value:** 43.12

#### Measurement

**Group ID:** BG002

**Spread:** 10.992

**Value:** 43.96

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 90

#### Measurement

**Group ID:** BG001

**Value:** 84

#### Measurement

**Group ID:** BG002

**Value:** 174

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 88

#### Measurement

**Group ID:** BG001

**Value:** 83

#### Measurement

**Group ID:** BG002

**Value:** 171

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 20

#### Measurement

**Group ID:** BG001

**Value:** 26

#### Measurement

**Group ID:** BG002

**Value:** 46

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 66

#### Measurement

**Group ID:** BG001

**Value:** 57

#### Measurement

**Group ID:** BG002

**Value:** 123

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 90

#### Measurement

**Group ID:** BG001

**Value:** 84

#### Measurement

**Group ID:** BG002

**Value:** 174

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 6
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** jed.rose@duke.edu
**Organization:** Duke Center for Smoking Cessation
**Phone:** 919-668-5055
**Title:** Dr. Jed E. Rose
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 41
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 38
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.354
- **Upper Limit:** 
- **Value:** -18.15
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.117
- **Upper Limit:** 
- **Value:** -15.49
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.520
- **Upper Limit:** 
- **Value:** -27.06
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.439
- **Upper Limit:** 
- **Value:** -28.64
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.124
- **Upper Limit:** 
- **Value:** -30.94
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.104
- **Upper Limit:** 
- **Value:** -28.75
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.471
- **Upper Limit:** 
- **Value:** -26.97
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.201
- **Upper Limit:** 
- **Value:** -30.82
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.563
- **Upper Limit:** 
- **Value:** -42.96
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 9.020
- **Upper Limit:** 
- **Value:** -33.52
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.551
- **Upper Limit:** 
- **Value:** -11.45
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.791
- **Upper Limit:** 
- **Value:** -7.15
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.494
- **Upper Limit:** 
- **Value:** -9.74
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.230
- **Upper Limit:** 
- **Value:** -4.72
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.885
- **Upper Limit:** 
- **Value:** -10.16
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.177
- **Upper Limit:** 
- **Value:** -10.88
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.396
- **Upper Limit:** 
- **Value:** -15.06
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.567
- **Upper Limit:** 
- **Value:** -8.52
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 10.707
- **Upper Limit:** 
- **Value:** -8.55
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 19.660
- **Upper Limit:** 
- **Value:** 21.96
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.148
- **Upper Limit:** 
- **Value:** -10.53
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.224
- **Upper Limit:** 
- **Value:** -4.40
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.065
- **Upper Limit:** 
- **Value:** -11.04
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.553
- **Upper Limit:** 
- **Value:** -4.42
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.981
- **Upper Limit:** 
- **Value:** -9.30
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.403
- **Upper Limit:** 
- **Value:** -11.66
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.153
- **Upper Limit:** 
- **Value:** -16.20
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.199
- **Upper Limit:** 
- **Value:** -8.64
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 10.872
- **Upper Limit:** 
- **Value:** -33.88
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 15.819
- **Upper Limit:** 
- **Value:** -35.44
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.620
- **Upper Limit:** 
- **Value:** 8.03
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.716
- **Upper Limit:** 
- **Value:** 10.72
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.675
- **Upper Limit:** 
- **Value:** 5.87
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.643
- **Upper Limit:** 
- **Value:** -4.40
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.763
- **Upper Limit:** 
- **Value:** 6.94
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.950
- **Upper Limit:** 
- **Value:** -4.03
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.117
- **Upper Limit:** 
- **Value:** 7.33
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.928
- **Upper Limit:** 
- **Value:** -1.56
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 15.516
- **Upper Limit:** 
- **Value:** 19.80
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 32.352
- **Upper Limit:** 
- **Value:** 49.01
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.480
- **Upper Limit:** 
- **Value:** -8.22
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.780
- **Upper Limit:** 
- **Value:** -12.26
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.001
- **Upper Limit:** 
- **Value:** -8.66
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.517
- **Upper Limit:** 
- **Value:** -14.40
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.25
- **Upper Limit:** 
- **Value:** -11.82
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.000
- **Upper Limit:** 
- **Value:** -12.50
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.526
- **Upper Limit:** 
- **Value:** -9.34
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.768
- **Upper Limit:** 
- **Value:** -19.83
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.269
- **Upper Limit:** 
- **Value:** -66.77
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.064
- **Upper Limit:** 
- **Value:** -57.15
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.720
- **Upper Limit:** 
- **Value:** -0.69
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.692
- **Upper Limit:** 
- **Value:** -7.78
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.994
- **Upper Limit:** 
- **Value:** -5.14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.791
- **Upper Limit:** 
- **Value:** -10.07
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.231
- **Upper Limit:** 
- **Value:** -7.67
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.777
- **Upper Limit:** 
- **Value:** -8.44
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.357
- **Upper Limit:** 
- **Value:** -8.05
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.897
- **Upper Limit:** 
- **Value:** -9.60
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.245
- **Upper Limit:** 
- **Value:** -67.72
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.026
- **Upper Limit:** 
- **Value:** -56.61
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.113
- **Upper Limit:** 
- **Value:** 1.41
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.887
- **Upper Limit:** 
- **Value:** -7.47
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.694
- **Upper Limit:** 
- **Value:** -1.12
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.697
- **Upper Limit:** 
- **Value:** -8.81
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.534
- **Upper Limit:** 
- **Value:** 0.92
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.120
- **Upper Limit:** 
- **Value:** -18.04
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.014
- **Upper Limit:** 
- **Value:** -4.36
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.507
- **Upper Limit:** 
- **Value:** -19.67
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.293
- **Upper Limit:** 
- **Value:** -65.87
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.618
- **Upper Limit:** 
- **Value:** -55.77
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.878
- **Upper Limit:** 
- **Value:** -5.15
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.120
- **Upper Limit:** 
- **Value:** 1.64
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.959
- **Upper Limit:** 
- **Value:** -17.67
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.735
- **Upper Limit:** 
- **Value:** -16.07
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.666
- **Upper Limit:** 
- **Value:** -14.46
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.868
- **Upper Limit:** 
- **Value:** -20.55
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.601
- **Upper Limit:** 
- **Value:** -16.61
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.085
- **Upper Limit:** 
- **Value:** -24.78
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.807
- **Upper Limit:** 
- **Value:** -56.97
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.905
- **Upper Limit:** 
- **Value:** -53.40
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** This will be determined by a composite of self-report at the 11-week study visit of no smoking between the 8-week and 11-week visits and expired air carbon monoxide (CO) \<10 ppm (measured at the 11-week study visit). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Period between 8-week and 11-week visits post target Quit Day
**Title:** Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits
**Type:** PRIMARY
**Unit of Measure:** participants
##### Group
**Description:** For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.

Chantix

Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** OG000
**Title:** Chantix
##### Group
**Description:** For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.

Chantix

Zyban

Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** OG001
**Title:** Chantix + Zyban
#### Outcome Measure 2
**Description:** This will be determined by a self-report of no smoking for the previous seven days when called for 6-month follow-up confirmed by expired air CO.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 6 months post Quit Day
**Title:** Number of Participants Completing Seven-day Point Abstinence From Smoking at 6 Months Post Quit Day
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.

Chantix

Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** OG000
**Title:** Chantix
##### Group
**Description:** For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.

Chantix

Zyban

Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** OG001
**Title:** Chantix + Zyban
#### Outcome Measure 3
**Description:** This will be determined by a composite of self-report of no smoking between study visits at the 1-week, 3-week, 7-week and 11-week post Quit Day study visits and expired air carbon monoxide (CO) \<10 ppm (measured at those study visits). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Quit Day to 11-week post Quit Day study visit
**Title:** Number of Participants Completing Continuous Abstinence From Smoking Between Quit Day and 11-week Post Quit Day Visit
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.

Chantix

Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** OG000
**Title:** Chantix
##### Group
**Description:** For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.

Chantix

Zyban

Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** OG001
**Title:** Chantix + Zyban
#### Outcome Measure 4
**Description:** Withdrawal symptoms will be assessed by questionnaire on Quit Day, Week 1, Week 3, Week 7 and Week 11 post target quit date and 6 months post quit Follow-Up (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** A total of 163 subjects (Chantix n=82, Chantix+Zyban n=81) attended the first post-quit visit. However, ten subjects (5 in each condition) failed to complete or return their Quit Day withdrawal questionnaires; therefore change scores could only be calculated for 153 subjects (Chantix n=77, Chantix+Zyban n=76).
**Reporting Status:** POSTED
**Time Frame:** Quit Day and 1 week, 3 weeks, 7 Weeks, 11 Weeks and 6 months post Quit Day
**Title:** Change in Smoking Withdrawal Symptoms
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** percentage of change
##### Group
**Description:** For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.

Chantix

Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** OG000
**Title:** Chantix
##### Group
**Description:** For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.

Chantix

Zyban

Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** OG001
**Title:** Chantix + Zyban
### Participant Flow Module
#### Group
**Description:** For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.

Chantix

Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** FG000
**Title:** Chantix
#### Group
**Description:** For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.

Chantix

Zyban

Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** FG001
**Title:** Chantix + Zyban
#### Group
**Description:** These subjects received nicotine patches at the first study visit but dropped out before randomization. 176 subjects attended the second study visit and provided side effects (SE) data. Two of these subjects dropped out during that visit (after providing SE data but prior to randomization). So, out of the initial 197 subjects receiving nicotine patches, 174 went on to receive Chantix or Chantix+Zyban; 23 subjects only received nicotine patches before dropping out.
**ID:** FG002
**Title:** Nicotine Patches Only
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 19
###### Reason
**Group ID:** FG001
**Number of Subjects:** 20
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 20
###### Reason
**Group ID:** FG001
**Number of Subjects:** 23
###### Reason
**Group ID:** FG002
**Number of Subjects:** 22
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 90
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 84
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 23
##### Milestone
**Type:** Completed SE Quest. After Using Patches
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 90
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 84
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 2
##### Milestone
**Type:** Randomized at Visit 2
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 90
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 84
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** Completed SE Quest. After Randomization
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 87
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 83
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 48
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 40
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 42
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 44
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 23
**Pre-Assignment Details:** Of the 376 subjs. enrolled, 179 were withdrawn by study staff or withdrew voluntarily from further participation prior to the 1st study visit (V1). 197 subjs. met all study criteria, attended V1 \& given NRT for 1 week; 176 subjs. attended V2 \& completed SE quest.; 2 subjs. dropped out during this visit before randomization; 174 subjs. randomized.
**Recruitment Details:** Recruitment began on 3/4/2013 and ended on 9/7/2014. Of the 376 subjects (subjs.) consented during this period, 197 subjects met all study criteria.
**Has Results:** True