Status:
COMPLETED
Early Phase II Trials for Cocaine Medication Development - 1
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Research Foundation for Mental Hygiene, Inc.
Conditions:
Cocaine-Related Disorders
Substance-Related Disorders
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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 tr...
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 ...
Eligibility Criteria
Inclusion:
- good standing at methadone maintenance program
- DSM-IV criteria for cocaine dependence or abuse
- used cocaine at least 4 times in last month
- able to give informed consent
Exclusion criteria
- currently meets DSM-IV criteria for Major depression or dysthymia
- meets DSM-IV criteria for attention deficit hyperactivity disorder, bipolar disorder, schizophrenia or any psychotic disorder
- history of seizures
- history of allergic reaction to risperidone
- chronic organic mental disorder
- significant current suicidal risk
- pregnancy, lactation or failure to use adequate birth control (for females)
- unstable physical disorders that may make participation hazardous
- coronary vascular disease
- cardiac conduction system disease as indicated by QRS duration >/= 0.11
- current use of other prescribed psychotropic medications
- history of failure to respond to a previous adequate trial of risperidone
- history of neuroleptic malignant syndrome, tardive dyskinesia, or severe extrapyramidal reactions to neuroleptic medications
- current DSM-IV criteria for another substance dependence other than nicotine.
Key Trial Info
Start Date :
August 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 1999
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00000317
Start Date
August 1 1996
End Date
July 1 1999
Last Update
June 26 2017
Active Locations (1)
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1
NYS Psychiatric Institute
New York, New York, United States, 10032