## Protocol Section
### Identification Module
**NCT ID:** NCT00706979

**Brief Title:** A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers

**Official Title:** A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers

#### Organization Study ID Info
**ID:** 1R01DA021619-01A1
**Link:** https://reporter.nih.gov/quickSearch/1R01DA021619-01A1
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** Medical University of South Carolina
#### Secondary ID Infos
**ID:** 1R01DA021619-01A1
**Link:** https://reporter.nih.gov/quickSearch/1R01DA021619-01A1
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2010-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-12-09

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-11-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-10

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2011-12-09

**Type:** ESTIMATED

**Results First Submit Date:** 2011-11-07

**Results First Submit QC Date:** 2011-11-07

#### Start Date
**Date:** 2008-09

**Status Verified Date:** 2010-10

#### Study First Post Date
**Date:** 2008-06-30
**Type:** ESTIMATED
**Study First Submit Date:** 2008-06-26
**Study First Submit QC Date:** 2008-06-26
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

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

#### Lead Sponsor

**Class:** OTHER

**Name:** Medical University of South Carolina

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A sample of smokers who have no current plans to quit will be recruited for this study and randomized to one of two intervention conditions:

1. Practice Quit Attempt (PQA) aided by brief advice and self-help materials, or
2. PQA aided by advice and self-help materials plus nicotine replacement therapy (NRT).

This study will test whether adding free nicotine replacement therapy to brief advice to undertake a practice quit attempt will motivate more smokers to make a serious attempt to stop smoking than brief advice without NRT. All treatments and assessments will be delivered via telephone and mailing. The primary outcome of interest is the incidence of a serious attempt to permanently stop smoking made over a six-month study period.

Our specific hypotheses are as follows:

Hypothesis 1: Helping smokers to make a practice quit attempt aided by NRT will result in a higher incidence of making a serious effort to quit smoking permanently, compared to an aided practice quit attempt without NRT. We also expect provision of NRT will increase point prevalence abstinence at 6 month follow-up.

Hypothesis 2: This relationship between NRT-aided practice quit attempts and quit behaviors will be mediated by a) increased smoking related self efficacy, b) increased belief in the efficacy of NRT, c) fewer concerns about adverse events of NRT, d) increased social support for not smoking, and e) less withdrawal distress and craving during the practice quit attempt.

### Conditions Module

**Conditions:**

- Smoking

- Smoking Cessation

**Keywords:**

- smoking

- smoking cessation

- nicotine replacement therapy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 849

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Practice Quit Attempt plus Nicotine Replacement Therapy

**Intervention Names:**

- Other: Practice Quit Attempt plus nicotine lozenge

**Label:** 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Practice Quit Attempt only

**Intervention Names:**

- Behavioral: Practice Quit Attempt only

**Label:** 2

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** nicotine lozenge, 2 mg or 4 mg

**Name:** Practice Quit Attempt plus nicotine lozenge

**Other Names:**

- Nicotine lozenge

- Nicotine Replacement Therapy (NRT)

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- 2

**Description:** Practice Quit Attempts (PQA) message aided by brief advice and self-help materials

**Name:** Practice Quit Attempt only

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The primary outcome was an attempt to quit smoking for good. To distinguish from a PQA, we specifically asked participants if they tried to quit smoking with the intent of quitting for good. Quit attempts were defined as any self-defined attempt to quit for good.

**Measure:** A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking

**Time Frame:** From study enrollment through six month follow-up

**Description:** Serious quit attempt of \>=24hrs, which fits the CDC's definition of a quit attempt.

**Measure:** A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking

**Time Frame:** From study enrollment through six month follow-up

#### Secondary Outcomes

**Measure:** Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days

**Time Frame:** At any point during the study

**Measure:** Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days

**Time Frame:** At 6-month follow-up

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Current cigarette smoker of at least 10 cigarettes per day
* Interested in quitting at some time
* Not currently interested in quitting smoking
* Access to telephone (home or work) for 6 month study period

Exclusion Criteria:

* Monthly cigar, pipe, or smokeless tobacco use
* Current pregnancy or breastfeeding
* Recent cardiovascular distress
* Phenylketonuria (PKU)
* Previous use of nicotine replacement therapy (gum, patch, lozenge, inhaler, or nasal spray)

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Medical University of South Carolina

**Name:** Matthew J Carpenter, Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Carpenter MJ, Hughes JR, Gray KM, Wahlquist AE, Saladin ME, Alberg AJ. Nicotine therapy sampling to induce quit attempts among smokers unmotivated to quit: a randomized clinical trial. Arch Intern Med. 2011 Nov 28;171(21):1901-7. doi: 10.1001/archinternmed.2011.492.

**PMID:** 22123796

## Derived Section

### 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

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CNSSti

- Name: Central Nervous System Stimulants

### Intervention Browse Module - Browse Leaves

- ID: M12478

- Name: Nicotine

- Relevance: HIGH

- As Found: Prior to

- 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

### Intervention Browse Module - Meshes

- ID: D000009538

- Term: Nicotine

### Misc Info Module

#### Removed Countries

- Country: United States

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Practice Quit Attempt Plus Nicotine Replacement Therapy

**Description:** This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.

**ID:** EG000

**Other Num Affected:** 179

**Other Num at Risk:** 426

**Serious Number At Risk:** 426

**Title:** Practice Quit Attempt Plus Nicotine Replacement Therapy

**Group ID:** EG001

**Title:** Practice Quit Attempt Only

**Description:** This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).

**ID:** EG001

**Serious Number Affected:** 1

**Serious Number At Risk:** 423

**Title:** Practice Quit Attempt Only

**Frequency Threshold:** 5

#### Other Events

**Term:** Nausea/stomach upset (dyspepsia)

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Throat irritation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Hiccups

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Heartburn

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Death

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** We were notified of the death of a participant from bladder cancer in the control group(PQA Only group, did not receive nicotine replacement therapy) by the participant's wife.

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 426

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 423

**Num Events:** 1

**Time Frame:** Adverse events were collected in the Practice Quit Attempt (PQA) + Nicotine Replacement Therapy (NRT) group only. They were collected at every follow-up study visit, which included 5 time points over a 7.5 month (32 weeks) period.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 426

**Group ID:** BG001

**Value:** 423

**Group ID:** BG002

**Value:** 849

**Units:** Participants

### Group

**ID:** BG000

**Title:** Practice Quit Attempt Plus Nicotine Replacement Therapy

**Description:** This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.

### Group

**ID:** BG001

**Title:** Practice Quit Attempt Only

**Description:** This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).

### 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:** 382

#### Measurement

**Group ID:** BG001

**Value:** 389

#### Measurement

**Group ID:** BG002

**Value:** 771

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

#### Measurement

**Group ID:** BG000

**Value:** 44

#### Measurement

**Group ID:** BG001

**Value:** 34

#### Measurement

**Group ID:** BG002

**Value:** 78

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 11.8

**Value:** 50.5

#### Measurement

**Group ID:** BG001

**Spread:** 11.4

**Value:** 50.7

#### Measurement

**Group ID:** BG002

**Spread:** 11.6

**Value:** 50.6

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 266

#### Measurement

**Group ID:** BG001

**Value:** 279

#### Measurement

**Group ID:** BG002

**Value:** 545

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 160

#### Measurement

**Group ID:** BG001

**Value:** 144

#### Measurement

**Group ID:** BG002

**Value:** 304

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 426

#### Measurement

**Group ID:** BG001

**Value:** 423

#### Measurement

**Group ID:** BG002

**Value:** 849

**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:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** carpente@musc.edu
**Organization:** Medical University of South Carolina'
**Phone:** 843-792-3974
**Title:** Matthew J. Carpenter
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 1.1
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.4
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** A logistic regression model was used to examine the primary hypothesis that NRT-enhanced PQAs would yield a higher rate of any ever-occurring quit attempt.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.008
**P-Value Comment:** 
**Parameter Type:** Risk Ratio (RR)
**Parameter Value:** 1.2
**Statistical Comment:** 
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** False
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 1.0
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.7
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** A logistic regression model was used to examine the secondary hypothesis that NRT-enhanced PQAs would yield a higher rate of 7 days of abstinence at some point during the study.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.09
**P-Value Comment:** 
**Parameter Type:** Risk Ratio (RR)
**Parameter Value:** 1.3
**Statistical Comment:** 
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** False
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 1.1
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.5
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** A logistic regression model was used to examine the primary hypothesis that NRT-enhanced PQAs would yield a higher rate for the primary outcome of any 24hr quit attempt.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.004
**P-Value Comment:** 
**Parameter Type:** Risk Ratio (RR)
**Parameter Value:** 1.3
**Statistical Comment:** 
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** False
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 0.9
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.6
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** A logistic regression model was used to examine the secondary hypothesis that NRT-enhanced PQAs would yield a higher rate for 7 days of abstinence at the six month follow-up.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.3
**P-Value Comment:** 
**Parameter Type:** Risk Ratio (RR)
**Parameter Value:** 1.2
**Statistical Comment:** 
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** False
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 208
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 168
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 82
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 63
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 185
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 143
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 68
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 57
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The primary outcome was an attempt to quit smoking for good. To distinguish from a PQA, we specifically asked participants if they tried to quit smoking with the intent of quitting for good. Quit attempts were defined as any self-defined attempt to quit for good.
**Parameter Type:** NUMBER
**Population Description:** All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.
**Reporting Status:** POSTED
**Time Frame:** From study enrollment through six month follow-up
**Title:** A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking
**Type:** PRIMARY
**Unit of Measure:** participants
##### Group
**Description:** This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
**ID:** OG000
**Title:** Practice Quit Attempt Plus Nicotine Replacement Therapy
##### Group
**Description:** This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
**ID:** OG001
**Title:** Practice Quit Attempt Only
#### Outcome Measure 2
**Parameter Type:** NUMBER
**Population Description:** All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.
**Reporting Status:** POSTED
**Time Frame:** At any point during the study
**Title:** Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
**ID:** OG000
**Title:** Practice Quit Attempt Plus Nicotine Replacement Therapy
##### Group
**Description:** This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
**ID:** OG001
**Title:** Practice Quit Attempt Only
#### Outcome Measure 3
**Description:** Serious quit attempt of \>=24hrs, which fits the CDC's definition of a quit attempt.
**Parameter Type:** NUMBER
**Population Description:** All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.
**Reporting Status:** POSTED
**Time Frame:** From study enrollment through six month follow-up
**Title:** A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking
**Type:** PRIMARY
**Unit of Measure:** participants
##### Group
**Description:** This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
**ID:** OG000
**Title:** Practice Quit Attempt Plus Nicotine Replacement Therapy
##### Group
**Description:** This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
**ID:** OG001
**Title:** Practice Quit Attempt Only
#### Outcome Measure 4
**Parameter Type:** NUMBER
**Population Description:** All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.
**Reporting Status:** POSTED
**Time Frame:** At 6-month follow-up
**Title:** Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
**ID:** OG000
**Title:** Practice Quit Attempt Plus Nicotine Replacement Therapy
##### Group
**Description:** This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
**ID:** OG001
**Title:** Practice Quit Attempt Only
### Participant Flow Module
#### Group
**Description:** This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
**ID:** FG000
**Title:** Practice Quit Attempt Plus Nicotine Replacement Therapy
#### Group
**Description:** This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
**ID:** FG001
**Title:** Practice Quit Attempt Only
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 426
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 423
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 426
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 423
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Pre-Assignment Details:** Participants were randomized to treatment group in a 1:1 ratio using a random number generator with block randomization before research staff made calls to initiate formal study enrollment.
**Recruitment Details:** Participants were recruited from 1/2009 - 2/2010 via the internet from an email database of potential enrollees provided by a market research firm. Eligible participants were mailed an informed consent and asked to return a signed copy if they wished to participate. Research staff then made calls to initiate formal study enrollment.
**Has Results:** True