Dextroamphetamine as an Adjunct in Cocaine/Opiate Dependent Patients
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cocaine-Related Disorders
- Sponsor
- National Institute on Drug Abuse (NIDA)
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Addiction severity
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients.
Detailed Description
This 27-week double-blind, placebo controlled treatment is designed to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients. All subjects will receive methadone. For the treatment of cocaine dependence, subjects will receive one of 2 doses of dextroamphetamine (15 or 30mg) or placebo. After 4 weeks of treatment the dose level of dextroamphetamine is doubled (30 or 60mg). This dose is maintained for 20 weeks; during which subjects attend twice weekly visits to the clinic and receive weekly cognitive behavioral therapy. Follow up evaluations will be conducted out to 3 months post treatment. Subjects will be assisted in transferring to Houston area methadone clinics to maintain treatment for opiate dependence following treatment completion.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Addiction severity
Medication compliance
Craving
Retention
Mood indicators
Psychiatric interview
Drug use
Secondary Outcomes
- Effectiveness measures including psycho-social variables, side effects, and self-reported measures.