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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Research Foundation for Mental Hygiene |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00000317 |
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
Condition | Intervention | Phase |
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Cocaine-Related Disorders Substance-Related Disorders |
Drug: Risperidone Other: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Early Phase II Trials for Cocaine Medication Development |
Enrollment: | 31 |
Study Start Date: | August 1996 |
Study Completion Date: | July 1999 |
Primary Completion Date: | July 1999 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Placebo
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Other: Placebo
Placebo
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2: Experimental
Risperidone (4mg/day)
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Drug: Risperidone
Risperidone (4mg/day)
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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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Please contact site for information.
United States, New York | |
Research Foundation for Mental Hygiene | |
New York, New York, United States, 10032 |
Principal Investigator: | Edward Nunes, M.D. | Research Foundation for Mental Hygiene |
Responsible Party: | NYPSI ( Edward Nunes, MD ) |
Study ID Numbers: | NIDA-09582-1, R01-09582-1 |
Study First Received: | September 20, 1999 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00000317 |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
Cocaine-Related Disorders Dopamine Mental Disorders Risperidone |
Substance-Related Disorders Disorders of Environmental Origin Cocaine Serotonin |
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Pathologic Processes Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |