Drug Use Clinical Trial
Official title:
Therapeutic Workplace Maintenance Study
Verified date | August 2017 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This application is a competing continuation of a grant in which we developed and pilot tested a computerized Therapeutic Workplace designed to train and employ adults as data entry operators. A randomized trial is planned over 5 years to investigate the Therapeutic Workplace business as a maintenance intervention to sustain long-term abstinence and employment. Welfare recipients in methadone treatment, actively using cocaine, and at risk for contracting or spreading HIV infection will participate in an initial Therapeutic Workplace training phase. Participants who become abstinent and skilled will be randomly assigned to an Abstinence & Employment, or an Employment Only group. Participants in the Abstinence & Employment group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary. Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work. This study will provide a rigorous evaluation of the efficacy of the Therapeutic Workplace business as a long-term treatment of cocaine addiction and unemployment; determine the benefits of requiring daily evidence of abstinence to work; and provide information on the extent to which a Therapeutic Workplace business can become self-sustaining. This research could provide firm scientific foundation for the dissemination of Therapeutic Workplace businesses in the long-term treatment of cocaine addiction and unemployment. The main hypothesis being tested is that cocaine abstinence will be reliably maintained during the yearlong intervention evaluation period only in the group exposed to the explicit abstinence maintenance intervention. We expect that cocaine abstinence in the Abstinence and Employment group will be significantly greater than cocaine abstinence in the Employment Only group.
Status | Completed |
Enrollment | 51 |
Est. completion date | August 2007 |
Est. primary completion date | August 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Applicants in methadone treatment may be eligible to participate in Phase 1 of the study. - Applicants will be blind to the full details of the eligibility criteria. - Unemployed - Provided a urine sample at intake with a detectable concentration of cocaine metabolite or provided a cocaine positive sample during regular urinalysis testing at a methadone maintenance program - Met DSM-IV criteria for cocaine dependence - Were receiving welfare benefits in Baltimore, MD - Received a score of less than or equal to 80% correct on a reading assessment Exclusion Criteria - Being at imminent risk for suicide - Reported hallucinations - Being incarcerated or otherwise under constant monitoring - Earned less than or equal to $200 in unreported taxable income from legal activity in the previous month - Having physical limitations that prevented typing |
Country | Name | City | State |
---|---|---|---|
United States | The Center for Learning and Health | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Institute on Drug Abuse (NIDA) |
United States,
DeFulio A, Donlin WD, Wong CJ, Silverman K. Employment-based abstinence reinforcement as a maintenance intervention for the treatment of cocaine dependence: a randomized controlled trial. Addiction. 2009 Sep;104(9):1530-8. doi: 10.1111/j.1360-0443.2009.02 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Monthly Urine Samples That Are Negative for Cocaine | The percentage of urine samples collected at monthly assessments that are negative for cocaine. | 1 year | |
Secondary | Percentage of Monday, Wednesday and Friday Urine Samples That Are Negative for Cocaine | (The number of Monday, Wednesday and Friday urine samples negative for cocaine/total number of urine samples) x 100. We have not confirmed the accuracy/completeness of the Mon, Wed, Fri urine data at this point. In addition, the monthly data had less missing data than the Monday, Wednesday and Friday data and were sufficient to show the main results of the trial. |
1 year | |
Secondary | Percentage of 30-day Assessment Urine Samples Negative for Opiates | (The number of monthly urine samples negative for opiates/total number of urine samples) x 100 | 1 year | |
Secondary | Percentage of Monday, Wednesday and Friday Urine Samples That Are Negative for Opiates | (The number of Monday, Wednesday and Friday urine samples negative for opiates/total number of urine samples) x 100. We have not confirmed the accuracy/completeness of the Mon, Wed, Fri urine data at this point. In addition, the monthly data had less missing data than the Monday, Wednesday and Friday data and were sufficient to show the main results of the trial. |
1 year | |
Secondary | HIV Risk Behaviors | Percentage of people reporting that they traded sex for drugs or money | 1 year |
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