Employment-Based Reinforcement to Motivate Naltrexone Ingestion and Drug Abstinence in the Treatment of Drug Addiction. - 1
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Purpose
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 |
Behavioral: Contingency management |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Employment-Based Addiction Pharmacotherapy |
- percentage of urine samples negative for naltrexone
- percentage of urine samples negative for opiates
- percentage of urine samples negative for cocaine
- HIV risk behaviors
- cost benefit analysis
- percentage of urine/breath samples negative for other drugs of abuse
| Estimated Enrollment: | 275 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00149669
| Contact: Karly N Diemer, M.A., B.S. | (410)550-6723 | kdiemer@jhmi.edu |
| United States, Maryland | |
| The Center for Learning and Health | Not yet recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Contact: Kenneth Silverman, Ph.D. 410-550-2694 ksilverm@jhmi.edu | |
| Principal Investigator: | Kenneth Silverman, Ph.D. | Johns Hopkins University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00149669 History of Changes |
| Other Study ID Numbers: | NIDA-19386-1, R01-19386-1 |
| Study First Received: | September 6, 2005 |
| Last Updated: | November 3, 2005 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Heroin Dependence Substance Abuse, Intravenous Chemically-Induced Disorders |
Mental Disorders Opioid-Related Disorders Substance-Related Disorders |
ClinicalTrials.gov processed this record on March 03, 2015