Effects of Vigabatrin on Cocaine Self-Administration

NCT ID: NCT00373581

Last Updated: 2016-10-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2006-12-31

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 neural GABA levels by irreversibly inhibiting the primary GABA degradation enzyme, GABA-transaminase; the hypothesized mechanism by which vigabatrin decreases cocaine relapse is by increasing GABA levels, thereby decreasing the effects of cocaine and cocaine-associated environmental cues on extracellular dopamine concentrations in the mesolimbic dopaminergic pathway (Morgan and Dewey, 1998). We are proposing to use our model of repeated dose cocaine self-administration to assess the interaction between vigabatrin and smoked cocaine under controlled laboratory conditions. This 57-day outpatient/inpatient /outpatient/inpatient protocol will evaluate the effects of vigabatrin maintenance (0, 3 g/day) on cocaine craving, subjective effects, and self-administration using a within-subjects design. Non-treatment seeking cocaine-dependent volunteers will be maintained outpatient for 14 days of vigabatrin maintenance prior to beginning each inpatient study phase. During the inpatient phases, volunteers will live on a hospital clinical research unit and will participate in laboratory sessions in which they will have the opportunity to purchase doses of smoked cocaine (0, 12, 25, 50 mg; $5/administration). In addition to measuring cocaine self-administration, we will measure the cardiovascular and subjective effects of repeated cocaine administration and cocaine craving under each vigabatrin maintenance condition. Determining vigabatrin's effects on a range of smoked cocaine doses will provide essential data on the mechanism of the vigabatrin-cocaine interaction.

Conditions

Cocaine Dependence

Keywords

Vigabatrin; GABA levels; Smoked cocaine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vigabatrin, cocaine

Group Type: EXPERIMENTAL

Vigabatrin

Intervention Type: DRUG

Cocaine

Intervention Type: DRUG

placebo, cocaine

Group Type: PLACEBO_COMPARATOR

Vigabatrin

Intervention Type: DRUG

Cocaine

Intervention Type: DRUG

Interventions

Vigabatrin

Intervention Type: DRUG

Cocaine

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novel Cocaine Pharmacotherapies

UNKNOWN

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret Haney, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

Irving Center for Clinical Research

New York, New York, United States

Countries

United States

Other Identifiers

DA 10755

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

5096

Identifier Type: -

Identifier Source: org_study_id