Effects of Vigabatrin on Cocaine Self-Administration

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Cocaine Dependence

In brief

The objective of this study is to determine if vigabatrin will decrease cocaine self-administration, cardiovascular effects, subjective effects and craving compared to placebo.

Key facts

Study ID

NCT00373581

Run by

New York State Psychiatric Institute

People needed

1

Starts

2006-04-01

Expected to finish

2006-12-01

Last updated by the study team

2016-10-27

Who can join

Age: 21 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Irving Center for Clinical Research — New York, New York, United States

Full record on ClinicalTrials.gov

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