Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3
The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Dextroamphetamine as an Adjunct in Cocaine/Opiate Dependent Patients|
- Drug use
- Medication compliance
- Addiction severity
- Mood indicators
- Psychiatric interview
- Effectiveness measures including psycho-social variables, side effects, and self-reported measures.
|Study Start Date:||September 1994|
|Estimated Study Completion Date:||September 2001|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000306
|United States, Texas|
|University of Texas Health Science Center|
|Houston, Texas, United States, 77225|
|Principal Investigator:||John Grabowski, Ph.D.||University of Texas|