CompletedPhase 1

Vigabatrin Ph 1 Cocaine Interaction Study

United States24 participantsStarted 2008-02

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Be between 18 and 45 years of age, inclusive * Currently be a non-treatment seeking cocaine user as confirmed by a positive urine test for cocaine * Able to provide written informed consent * A negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine Exclusion Criteria: Please contact site for more information.

What they're measuring

safety/tolerability and AE assessments including HR/BP/ECG/QTc

Timeframe: 56 days

Trial details

NCT IDNCT00626834

SponsorNational Institute on Drug Abuse (NIDA)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2010-10

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