## Protocol Section
### Identification Module
**NCT ID:** NCT01082679

**Brief Title:** Treatment for Opioid Dependent Offenders

**Official Title:** Treatment for Opioid Dependent Offenders

#### Organization Study ID Info
**ID:** H-2008-0242
#### Organization
**Class:** OTHER
**Full Name:** University of Wisconsin, Madison
### Status Module
#### Completion Date
**Date:** 2011-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-06-05

**Type:** ACTUAL

**Last Update Submit Date:** 2023-06-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-03

**Type:** ACTUAL

#### Start Date
**Date:** 2009-06

**Status Verified Date:** 2019-05

#### Study First Post Date
**Date:** 2010-03-08
**Type:** ESTIMATED
**Study First Submit Date:** 2010-03-05
**Study First Submit QC Date:** 2010-03-05
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Wisconsin, Milwaukee

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Wisconsin, Madison

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This pilot study is examining the feasibility of a primary care and a specialist treatment (methadone clinic) model of treatment for 15 offenders who are part of two community supervision programs: Drug Court and the Treatment Alternative Program (TAP) in Dane County. The questions addressed by future larger studies based upon the current pilot-feasibility study will center around whether access to primary health care as opposed to more traditional methadone treatment services will improve the health and criminal justice outcomes for participants.

### Conditions Module

**Conditions:**

- Opioid Dependence

**Keywords:**

- opioid dependent

- methadone

- Suboxone

- buprenorphine

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 16

**Type:** ACTUAL

**Phases:**

- PHASE2

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Methadone

**Label:** methadone via specialty care

**Type:** OTHER

#### Arm Group 2

**Intervention Names:**

- Drug: buprenorphine (Suboxone)

**Label:** Suboxone via specialty care

**Type:** OTHER

#### Arm Group 3

**Intervention Names:**

- Drug: buprenorphine (Suboxone)

**Label:** Suboxone via primary care

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- methadone via specialty care

**Description:** daily for 12 months

**Name:** Methadone

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Suboxone via primary care

- Suboxone via specialty care

**Description:** daily for 12 months

**Name:** buprenorphine (Suboxone)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** This study is focused on Dane County Drug Treatment Court and Treatment Alternative Program participants.

The study will determine feasibility of monitoring participants in primary care as opposed to the usual standard of specialty care.

Feasibility of monitoring participants will be studied in terms of retention rate of participants in the study

**Measure:** Retention rate of participants in the study

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* diagnosis of opioid dependence
* opioid positive urine drug screen
* participation in local Drug Treatment Court or Treatment Alternative Program
* women of childbearing potential who have a negative screening urine pregnancy test and are willing to use appropriate birth control methods during the duration of the study

Exclusion Criteria:

* current alcohol or sedative dependence
* pregnancy
* women who are currently breast-feeding
* complex psychiatric co-morbidity (e.g. suicidality, psychosis)
* complex medical co-morbidity (e.g. major cardiovascular, renal, or gastrointestinal/hepatic disease)
* current pharmacotherapy with an agent which is contraindicated in combination with Suboxone or methadone according to drug labeling
* paralytic ileus, coronary artery disease or heart arrhythmia, recent head injury, obstructive sleep apnea, severe asthma or COPD, end-stage renal disease, or severe morbid obesity

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Madison

**Country:** United States

**Facility:** University of Wisconsin - Madison

**State:** Wisconsin

**Zip:** 53715

#### Overall Officials

**Official 1:**

**Affiliation:** University of Wisconsin - Madison, Department of Family Medicine

**Name:** Randy Brown, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Brown R, Gassman M, Hetzel S, Berger L. Community-based treatment for opioid dependent offenders: a pilot study. Am J Addict. 2013 Sep-Oct;22(5):500-2. doi: 10.1111/j.1521-0391.2013.12049.x. Epub 2013 Apr 3.

**PMID:** 23952897

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000079524

- Term: Narcotic-Related Disorders

- ID: D000019966

- Term: Substance-Related Disorders

- ID: D000064419

- Term: Chemically-Induced Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12244

- Name: Opioid-Related Disorders

- Relevance: HIGH

- As Found: Opioid Dependence

- ID: M2057

- Name: Narcotic-Related Disorders

- Relevance: LOW

- As Found: Unknown

- 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: D000009293

- Term: Opioid-Related Disorders

### Intervention Browse Module - Ancestors

- ID: D000000701

- Term: Analgesics, Opioid

- ID: D000009294

- Term: Narcotics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000009292

- Term: Narcotic Antagonists

- ID: D000000996

- Term: Antitussive Agents

- ID: D000019141

- Term: Respiratory System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: NarcAntag

- Name: Narcotic Antagonists

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnTuAg

- Name: Antitussive Agents

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: AnObAg

- Name: Anti-Obesity Agents

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

### Intervention Browse Module - Browse Leaves

- ID: M5317

- Name: Buprenorphine

- Relevance: HIGH

- As Found: Aortic

- ID: M11671

- Name: Methadone

- Relevance: HIGH

- As Found: Of Children

- ID: M447

- Name: Buprenorphine, Naloxone Drug Combination

- Relevance: HIGH

- As Found: Sling

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M12221

- Name: Naloxone

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M12245

- Name: Narcotics

- Relevance: LOW

- As Found: Unknown

- ID: M12243

- Name: Narcotic Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M13570

- Name: Phenylpropanolamine

- Relevance: LOW

- As Found: Unknown

- ID: M9238

- Name: Guaifenesin

- Relevance: LOW

- As Found: Unknown

- ID: M186319

- Name: Chlorpheniramine, phenylpropanolamine drug combination

- Relevance: LOW

- As Found: Unknown

- ID: M4312

- Name: Antitussive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21137

- Name: Respiratory System Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002047

- Term: Buprenorphine

- ID: D000008691

- Term: Methadone

- ID: D000069479

- Term: Buprenorphine, Naloxone Drug Combination

### Misc Info Module

- Version Holder: 2024-05-24
