Clinical trial NCT01723527: Diversion to Treatment for Injection Drug Users Arrested for Possession of Heroin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine-Related Disorders
HIV
Heroin Dependence
Keywords: Cocaine
Heroin
HIV
Contingency Management
Incentives
Criminal Justice
Methadone
Buprenorphine
Employment
Job Training
Wage Subsidies
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-11-08
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cocaine abstinence as assessed by urinalysis
timeFrame: One year
measure: Cocaine abstinence as assessed by self-reports
timeFrame: One year
Secondary outcomes:
measure: Any drug use (Y/N)
timeFrame: One year
measure: Any engagement in HIV risk behavior (Y/N)
timeFrame: One year
measure: Any criminal activity (Y/N)
timeFrame: One year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Center for Learning and Health
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Anthony DeFulio, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: