Effects of Vigabatrin on Cocaine Self-Administration

NCT00373581 | Terminated Phase 2

• 2 other identifiers: 5096DA 10755
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence

Keywords

Vigabatrin; GABA levels; Smoked cocaine

Outcome Measures

Primary Outcomes (4)

• Subjective effects

• Cardiovascular effects

• Cravings

• Cocaine Administration

Study Arms (2)

Vigabatrin, cocaine

EXPERIMENTAL

Drug: Vigabatrin; Drug: Cocaine

placebo, cocaine

PLACEBO COMPARATOR

Drug: Vigabatrin; Drug: Cocaine

Interventions

Vigabatrin DRUG

Vigabatrin, cocaine; placebo, cocaine

Cocaine DRUG

Vigabatrin, cocaine; placebo, cocaine

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Novel Cocaine Pharmacotherapies: collaborator

Study Sites (1)

Irving Center for Clinical Research

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Vigabatrin; Cocaine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Margaret Haney, Ph.D.

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2006
• First Posted: September 8, 2006
• Study Start: April 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: October 27, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)