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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Johns Hopkins University |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00149669 |
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 three groups. All 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 and Abstinence Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose of naltrexone or for providing an opiate or cocaine positive urine sample. 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 two groups 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 two groups exposed to the employment-based naltrexone treatment significantly more than the group exposed to usual-care treatment package. Cocaine abstinence will be increased in the group reinforced for cocaine abstinence significantly more than the group not exposed to abstinence reinforcement.
Condition | Intervention |
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Behavior Therapy Cocaine Cocaine (IV) Cocaine Abuse Cocaine Dependence Contingency Management HIV Risk Behaviors Heroin Heroin Dependence Naltrexone Opioid Dependence Substance Abuse, Intravenous Sexual Risk Behaviors |
Behavioral: Contingency management |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Employment-Based Addiction Pharmacotherapy |
Estimated Enrollment: | 275 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Karly N Diemer, M.A., B.S. | (410)550-6723 | kdiemer@jhmi.edu |
United States, Maryland | |
The Center for Learning and Health | |
Baltimore, Maryland, United States, 21224 |
Principal Investigator: | Kenneth Silverman, Ph.D. | Johns Hopkins University |
Study ID Numbers: | NIDA-19386-1, R01-19386-1 |
Study First Received: | September 6, 2005 |
Last Updated: | November 3, 2005 |
ClinicalTrials.gov Identifier: | NCT00149669 |
Health Authority: | United States: Federal Government |
Cocaine-Related Disorders Behavior, Addictive Mental Disorders Heroin Dependence HIV Infections Naltrexone |
Acquired Immunodeficiency Syndrome Substance-Related Disorders Disorders of Environmental Origin Opioid-Related Disorders Substance Abuse, Intravenous |