CompletedNot Applicable

Employment-based Reinforcement of Naltrexone Ingestion and Abstinence

United States67 participantsStarted 2005-12

Plain-language summary

A randomized study is planned over 5 years to evaluate the effectiveness of the Therapeutic Workplace in promoting naltrexone ingestion and abstinence in unemployed opiate-dependent injection drug users. Participants will be offered an opioid detoxification and naltrexone induction. Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work. This study will provide a rigorous evaluation of a novel employment-based intervention, the Therapeutic Workplace, to promote naltrexone ingestion and drug abstinence in a population of injection drug users who are at considerable risk of spreading or contracting HIV infection. Hypotheses being tested in this study are: Naltrexone ingestion will be maintained in the group exposed to the employment-based naltrexone treatment significantly more than the group exposed to usual-care treatment package. Opiate abstinence will be maintained in the group exposed to the employment-based naltrexone treatment significantly more than the group exposed to usual-care treatment package.

Who can participate

Age range18 Years – 65 Years

SexALL

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Volunteers were eligible to participate if they * were between the ages of 18 and 65 years, * were unemployed (i.e., reporting no work in the past 30 days and earning $200 in taxable income per month), * self-reported injection drug use and had visible track marks (assessed via visual inspection), * provided a urine sample that tested positive for both opiates and cocaine upon entry into detoxification, * met DSM-IV-TR criteria for opiate dependence, * were medically approved to be maintained on naltrexone by the study physician, * and lived within reasonable commuting distance to the research unit (i.e., in Baltimore City and the immediate surrounding area). Volunteers were excluded if they * had active hallucinations, delusions, or a thought disorder; * were judged to be of imminent threat to harm self or others; * were currently incarcerated, in a halfway house, or under constant monitoring; * were pregnant or breastfeeding; * had serum aminotransferase levels over 3 times normal; * required opiates for other medical problems (and thus could not be maintained on naltrexone, which would block the effects on any opiate); * reported an interest in methadone treatment; * had active tuberculosis; * or had physical limitations that would prevent typing

What they're measuring

Percentage of Urine Samples Positive for Naltrexone

Timeframe: 6 months

Trial details

NCT IDNCT00149669

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-12

Results submitted2016-09-02