Status:
COMPLETED
Effects of Aripiprazole on Cocaine Craving and Self-Administration
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Abuse
Eligibility:
All Genders
21-45 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate whether aripiprazole will decrease cocaine self-administration, subjective effects and cravings compared to placebo.
Detailed Description
Despite the recent increase in data about cocaine's basic neurochemical mechanisms of action, progress towards the development of an effective pharmacological treatment for cocaine abuse has been disa...
Eligibility Criteria
Inclusion
- Meets DSM-IV criteria for current cocaine abuse
- Average use of smoked cocaine is at least 2x/week for past 6 mos); currently spends at least $70 per week on cocaine
- Has patterns of smoked cocaine use in terms of frequency and amounts which parallel or exceed those administered in the study
- Age 21-45
- Able to give informed consent, and comply with study procedures
Exclusion
- Current seizure disorder, heart disease or psychiatric disorders (other than cocaine dependence)
- Dependence on substances other than cocaine or nicotine
- Request for drug treatment
- Judged to be noncompliant with study protocol
- Current use of any medication that has the potential to interact with aripiprazole (i.e., seizure medications, anti-fungal medications, cardiac medications, or medication that produces drowsiness)
- Clinical laboratory tests outside normal limits that are clinically unacceptable to the study physician (BP \> 140/90; BUN, creatinine, LFTs \> 1.5 ULN; hematocrit \< 34 for women, \< 36 for men; pseudocholinesterase deficiency)
- Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders other than transient psychosis due to drug abuse
- Current parole or probation
- History of significant violent or suicidal behavior
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00373880
Start Date
April 1 2005
End Date
September 1 2008
Last Update
September 11 2017
Active Locations (1)
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1
Irving Center for Clinical Research
New York, New York, United States, 10032