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
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	Behavior: Contingency management

Further Study Details: 

Primary Outcomes: percentage of urine samples negative for naltrexone; percentage of urine samples negative for opiates; percentage of urine samples negative for cocaine
Secondary Outcomes: HIV risk behaviors; cost benefit analysis; percentage of urine/breath samples negative for other drugs of abuse
Expected Total Enrollment:  275

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• CDU patients will be invited to participate in the study if they: a) self-report injection drug use; b) have observable injection track marks; c) provide opiate-positive urine at intake to the CDU; d) provided cocaine-positive urine at intake to the CDU; e) meet DSM IV criteria for Opiate Dependence; f) are unemployed; g) are between the ages of 18 and 65 years old; h) are medically approved to take naltrexone treatment; i) report no interest in methadone treatment; j) live within reasonable commuting distance to the Therapeutic Workplace (e.g, all Baltimore City zipcodes and the following Baltimore County zipcodes will be included: 21221, 21220, 21222, 21236, 21237, 21234, 21204, 21212).

Exclusion Criteria:

• Patients will be excluded if they a) have current major axis I disorders (e.g., Bipolar Disorder, Schizophrenia, Psychosis NOS, Schizophreniform Disorder, Schizoaffective Disorder); b) if they are pregnant or breastfeeding; c) if serum aminotransferases results are over three times normal; d) or if the need for opioids to treat an identified medical problem is anticipated; e) if physical limitations would prevent them from working (e.g., has a cast on their hand preventing them from using fingers to type). In addition, the patients with active tuberculosis are not kept on the CDU, so those individuals will not participate in this research. These criteria should maintain sample homogeneity, thereby minimizing the impact of potential confounding variables while insuring patient safety and ability to provide informed consent.

Please refer to this study by ClinicalTrials.gov identifier  NCT00149669

Karly N Diemer, M.A., B.S.      (410)550-6723    kdiemer@jhmi.edu

Maryland
      The Center for Learning and Health, Baltimore,  Maryland,  21224,  United States

Study chairs or principal investigators

Kenneth Silverman, Ph.D.,  Principal Investigator,  Johns Hopkins University   

Study ID Numbers:  NIDA-19386-1; R01-19386-1
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00149669
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13