Effects of Vigabatrin on Cocaine Self-Administration

• Status: Terminated
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: Novel Cocaine Pharmacotherapies
• Treatments: Cocaine; Vigabatrin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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