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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Cocaine-Related Disorders trials