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TerminatedNCT00373581Updated Oct 27, 2016

Effects of Vigabatrin on Cocaine Self-Administration

A Phase 2 interventional study of Vigabatrin and Cocaine in Cocaine Dependence, sponsored by New York State Psychiatric Institute. Terminated at 1 site in United States. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-27.

Sponsored by New York State Psychiatric Institute · Phase 2, Interventional, and Treatment

Why this study was terminated
Funding ran out
Phase
Phase 2
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
21 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cocaine Dependence

Keywords

  • Vigabatrin
  • GABA levels
  • Smoked cocaine
03

In context

Cocaine-Related Disorders

415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.

This study's enrollment of 1 is below the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.

Browse Cocaine-Related Disorders studies →

Lead sponsor

New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Vigabatrin, cocaine

    Drug: Vigabatrin · Drug: Cocaine

  • Placebo comparator
    placebo, cocaine

    Drug: Vigabatrin · Drug: Cocaine

Interventions

  • DrugVigabatrin
  • DrugCocaine
06

What researchers measure

Primary outcomes

  1. Subjective effects

  2. Cardiovascular effects

  3. Cravings

  4. Cocaine Administration

07

Study locations

1 site
  • Irving Center for Clinical Research
    New York, New York 10032, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00373581
Lead sponsor
New York State Psychiatric Institute
Collaborators
Novel Cocaine Pharmacotherapies
Responsible party
Sponsor
First posted
Sep 8, 2006
Start date
Apr 2006
Primary completion
Dec 2006
Completion
Dec 2006
Last update
Oct 27, 2016

Study contacts

Margaret Haney, Ph.D.
principal investigator · New York State Psychiatric Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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