Early Phase II Trials for Cocaine Medication Development - 1
- Conditions
- Cocaine-Related DisordersSubstance-Related Disorders
- Interventions
- Registration Number
- NCT00000317
- Lead Sponsor
- New York State Psychiatric Institute
- Brief Summary
The purpose of this study is to develop models for early Phase II testing of potential medications for cocaine dependence: amoxapine, risperidone and other agents.
The study was a controlled pilot trial of risperidone in opiate-dependent patients on methadone maintenance. The study explored whether risperidone reduced cocaine use, cocaine craving, and cocaine subjective effects in patients on methadone maintenance who abused cocaine and whether it had an acceptable side effect profile. This
- Detailed Description
This was an 18-week prospective, randomized, placebo-controlled crossover design with placebo lead-in phase and terminal placebo phase. After two weeks of single-blind placebo, patients were randomly assigned to one of two schedules of medication:
2 Week Baseline Weeks 1-6 Weeks 7-12 Weeks 13-18 Group 1 placebo risperidone placebo placebo Group 2 placebo placebo risperidone placebo
The first 6-week phase provided an initial double-blind medication-placebo comparison. In the second six-week phase (weeks 7-12), patients crossed over to the opposite treatment. During weeks 13-18, Group 1 patients remained on placebo while Group 2 patients were tapered from risperidone to placebo. For six weeks after the end of the trial, patients were offered routine clinical treatment with counseling and psychiatrist visits as needed. Medication dosage was titrated upwards on a fixed-flexible schedule to a maximum dose of 4 mg per day. Medication began at ½ mg risperidone for 3 days, then 1 mg for four days, 2 mg per day during week 2, 3 mg per day during week 3, and 4 mg per day during weeks 4-6. The titration schedule for risperidone in weeks 7-12 was the same as for weeks 1-6. In addition to treatment as usual, patients received a modified manual-guided relapse prevention counseling program in weekly meetings lasting approximately 20 minutes; these sessions provided cognitive and behavioral skills that were found to be helpful to patients in reducing cocaine use.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description PLacebo Placebo Placebo plus relapse prevention counseling PLacebo Relapse prevention counseling Placebo plus relapse prevention counseling Risperidone Relapse prevention counseling Risperidone (4mg/day) plus relapse prevention counseling Risperidone Risperidone Risperidone (4mg/day) plus relapse prevention counseling
- Primary Outcome Measures
Name Time Method Craving 3x/week during 18 weeks of trial subjective cravings were recorded on the Cocaine craving scale
Drug use 3x/week during 18 weeks of trial urine drug testing and self reported use on the Substance Use Weekly Inventory
Retention 18 weeks or length of study participation duration of individuals in the study.
Side effects 1x/week for 18 weeks Using the Modified Systemic Assessment for Treatment Emergent Effects the psychiatrist assessed side effects
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
NYS Psychiatric Institute
🇺🇸New York, New York, United States