Diversion to Treatment for Injection Drug Users Arrested for Possession of Heroin

HIV Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723527
• Other study ID #: 1R34DA033510-01
• Status: Completed
• Phase: Phase 1
• First received: November 6, 2012
• Last updated: December 10, 2014
• Start date: December 2012
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

More Americans are arrested for drug offenses than for any other crime. In 2009, over 294,000 arrests were made for possession of cocaine or heroin. Incarceration does not address the root problems and is frequently followed by relapse and re-arrest after release. In the case of opiate-dependent adults arrested for possession of heroin, one potentially effective alternative is to divert offenders to methadone maintenance treatment (MMT) as an alternative to adjudication of their case. MMT is an effective treatment for heroin dependence, and appears very effective for criminal offenders. However, cocaine use is common in MMT patients, including those with recent criminal justice involvement, and MMT alone is ineffective in addressing cocaine use. Continued cocaine use carries a substantial health burden and necessarily entails continued criminal activity. Thus, treatment for diverted opiate-dependent offenders should be designed to address cocaine use as well as opiate use. A Stage 1 Behavior Therapy Development project is planned over 2 years to adapt, manualize and pilot test the Therapeutic Workplace intervention for adults charged with heroin possession and offered diversion to methadone maintenance treatment as an alternative to adjudication of their case. The Therapeutic Workplace is a novel, employment-based contingency management intervention that has been very effective in promoting cocaine abstinence in adults who use cocaine persistently during methadone treatment. In the Therapeutic Workplace, participants are hired in a model workplace and required to provide drug-free urine samples to work and to earn maximum pay. Once we develop and manualize the adapted version of the Therapeutic Workplace for adults arrested for heroin possession, a pilot test will be conducted. Individuals identified by the State Attorney's office as candidates for diversion will be assessed for study eligibility. Given the high rates of injection drug use and injection-related transmission of HIV in Baltimore, this study will be restricted to injection drug users to evaluate the potential utility of this intervention in reducing HIV risk. Eligible individuals will be offered methadone maintenance in lieu of prosecution and will be required to remain in methadone treatment for 90 days. All participants will receive standard MMT, independent of whether they decide to participate in the pilot study. After beginning MMT, participants will be invited to enroll in the pilot study and randomly assigned to two study groups. Participants assigned to the Usual Care Diversion group will receive the standard MMT. Participants assigned to the Therapeutic Workplace Enhanced Diversion group will receive the standard MMT and the Therapeutic Workplace intervention. The data from this pilot study will serve as the foundation for a full-scaled randomized controlled trial. Overall, the Therapeutic Workplace could serve as a novel and ideal intervention for many heroin dependent adults involved in the criminal justice system. The use of MMT in lieu of adjudication in combination with the Therapeutic Workplace could increase drug abstinence and employment and decrease HIV risk and criminal activity in this refractory high-risk population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• report using heroin at least 20 of the last 30 days of living in the community

• meet criteria for methadone maintenance (at least one year of meeting DSM IV criteria for heroin dependence)

• have visible track marks or other clear physical evidence of injection drug use

• report using cocaine in the last 30 days

• were unemployed prior to arrest

• have a income below the federal poverty level

• live in the Baltimore City area

Exclusion Criteria:

• report current suicidal ideation or hallucinations

• receiving opioid pharmacotherapy prior to arrest

• have a serious uncontrolled medical condition that would prevent attendance in methadone or buprenorphine treatment

• are pregnant or breastfeeding

• have a physical imparement that would prevent typing

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders
• Heroin Dependence
• HIV

Intervention

Drug:
• Methadone
Clinic-Based Methadone Maintenance Treatment
• Buprenorphine
Clinic-Based Buprenorphine Maintenance Treatment

Behavioral:
• Employment-based drug abstinence reinforcement

Locations

Country	Name	City	State
United States	Center for Learning and Health	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cocaine abstinence as assessed by urinalysis	dichotomous (Y/N)	One year	No
Primary	Cocaine abstinence as assessed by self-reports	dichotomous (Y/N)	One year	No
Secondary	Any drug use (Y/N)	Any drug use will be counted as Yes if a urine sample indicates that the participant is positive for any of the DOT 5 drugs, or if the participant reports using any of the DOT 5 drugs (Amphetamines, Cocaine, Marijuana, Opiates, PCP).	One year	No
Secondary	Any engagement in HIV risk behavior (Y/N)	Any engagement in HIV risk behavior will be counted as Yes if a participant reports any unprotected vaginal or anal sex or reports any injection drug use that includes the sharing of injection equipment.	One year	No
Secondary	Any criminal activity (Y/N)	Criminal activity will counted as Yes if a participant reports any days of illegal activity in the previous 30 days, or has been arrested for any new crime in the previous 30 days according to publically available records maintained by the Maryland DPSCS.	One year	No

External Links

•   The Center for Learning and Health (Study site web page)