Status:
TERMINATED
Effects of Vigabatrin on Cocaine Self-Administration
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
Novel Cocaine Pharmacotherapies
Conditions:
Cocaine Dependence
Eligibility:
All Genders
21-45 years
Phase:
PHASE2
Brief Summary
The objective of this study is to determine if vigabatrin will decrease cocaine self-administration, cardiovascular effects, subjective effects and craving compared to placebo.
Detailed Description
Two recent open label clinical trials have reported that the anticonvulsant, gamma vinyl-GABA (GVG; vigabatrin), decreases relapse to cocaine use (Brodie et al., 2003, 2005). Vigabatrin increases neur...
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
- Agrees to practice an effective form of contraception
Exclusion
- Current seizure disorder or heart disease
- Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders. Volunteers with a history of depression or psychosis will also be excluded (p. 43, Investigator's brochure)
- Dependence on substances other than cocaine or nicotine
- Request for drug treatment
- Judged to be noncompliant with study protocol
- Clinical laboratory tests outside normal limits that are unacceptable to the study physician (e.g., BP \> 140/90; BUN, creatinine, LFTs \> 1.5 ULN; hematocrit \< 34 for women, \< 36 for men; pseudocholinesterase deficiency)
- Current parole or probation
- Recent history of significant violent or suicidal behavior
- Pregnancy or lactation
- Baseline visual field defects
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00373581
Start Date
April 1 2006
End Date
December 1 2006
Last Update
October 27 2016
Active Locations (1)
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1
Irving Center for Clinical Research
New York, New York, United States, 10032