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Vigabatrin Ph 1 Cocaine Interaction Study

NCT00626834 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-01-12

No results posted yet for this study

Summary

This is a Phase 1 safety/tolerably study to determine if there are clinically significant interactions between oral vigabatrin (gamma vinyl-gamma-amino butyric acid; VGB) concurrent with intravenous (IV) cocaine infusions.

Conditions

  • Cocaine Addiction

Interventions

DRUG

Vigabatrin

Dose 1 BID

DRUG

Vigabatrin

Dose 2 BID

DRUG

Vigabatrin

Dose 3 BID

DRUG

Matching placebo

Matching placebo BID

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • John D. Roache, Ph.D. · University of Texas

  • Nora Chiang, Ph.D. · National Institute on Drug Abuse (NIDA)

  • Ahmed Elkashef, M.D. · National Institute on Drug Abuse (NIDA)

  • Roberta Kahn, M.D. · National Institute on Drug Abuse (NIDA)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00626834 on ClinicalTrials.gov