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

NCT01723527 | Completed Phase 1 DMC

• 1 other identifier: 1R34DA033510-01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cocaine-Related Disorders; HIV; Heroin Dependence

Keywords

Cocaine; Heroin; HIV; Contingency Management; Incentives; Criminal Justice; Methadone; Buprenorphine; Employment; Job Training; Wage Subsidies

Outcome Measures

Primary Outcomes (2)

• Cocaine abstinence as assessed by urinalysis

  dichotomous (Y/N)

  One year

• Cocaine abstinence as assessed by self-reports

  dichotomous (Y/N)

  One year

Secondary Outcomes (3)

• Any drug use (Y/N)

  One year

• Any engagement in HIV risk behavior (Y/N)

  One year

• Any criminal activity (Y/N)

  One year

Study Arms (2)

Therapeutic Workplace

EXPERIMENTAL

Participants assigned to this condition will receive the standard services and requirements for diversion as described for the usual care group, and will also be eligible to attend the three-phase Therapeutic Workplace (TW) intervention. All phases of this intervention include employment-based drug abstinence reinforcement contingencies. Under these contingencies, participants can work and earn wages or wage subsidies contingent upon drug abstinence as verified by urinalysis. Phase 1 of the TW intervention is expected to increase cocaine abstinence and to prepare participants for employment. Phase 2 of the TW intervention is expected to maintain abstinence while participants are employed in an onsite model workplace. Phase 3 is designed to increase employment in community jobs and to maintain abstinence while participants are employed in offsite community workplaces.

Drug: Methadone; Drug: Buprenorphine; Behavioral: Employment-based drug abstinence reinforcement

Diversion to treatment (Usual Care)

ACTIVE COMPARATOR

Participants in this condition will be offered the standard treatment services available in community methadone and buprenorphine programs, including medication (methadone or buprenorphine, respectively), counseling services, HIV testing, and case management. All services will be provided in the treatment clinics. There are a number of clinics within easy walking distance from the research site, and others throughout the city that are reachable by public transportation from the research site. In addition, all participants will receive referrals to the Re-Entry Center, a One-Stop Career Center tailored to the needs of offenders, at all intake and monthly assessments. As mentioned in detail above, participants will be required by the court to stay enrolled in treatment for 90 days. It is important to note that all diverted individuals will receive these services and requirements, independent of whether they agree to participate in the pilot study.

Drug: Methadone; Drug: Buprenorphine

Interventions

Methadone DRUG

Clinic-Based Methadone Maintenance Treatment

Diversion to treatment (Usual Care); Therapeutic Workplace

Buprenorphine DRUG

Clinic-Based Buprenorphine Maintenance Treatment

Diversion to treatment (Usual Care); Therapeutic Workplace

Employment-based drug abstinence reinforcement BEHAVIORAL

Also known as: Therapeutic Workplace

Therapeutic Workplace

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Center for Learning and Health

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Heroin Dependence

Interventions

Methadone; Buprenorphine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Opioid-Related Disorders; Narcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Anthony DeFulio, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: November 8, 2012
• Study Start: December 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 11, 2014

Record last verified: 2014-12

Locations

US (1)