CompletedEarly Phase 1

GABA (Gamma Amino Butyric Acid) Medication for Tobacco

United States24 participantsStarted 2007-08

Plain-language summary

The goal of this study is to examine the effects of a GABA (gamma amino butyric acid)-enhancing medication, pregabalin (300 mg/day), on smoking behavior, tobacco withdrawal and cigarette craving in smokers. We hypothesize that in smokers, pregabalin at 300 mg/day, will be more effective than placebo in decreasing smoking behavior and attenuating tobacco withdrawal and cigarette craving.

Who can participate

Age range18 Years – 55 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: * Female and male smokers, aged 18 to 55 years * History of smoking daily for the past 12 months * at least 15 cigarettes daily * In good health as verified by medical history * screening examination * screening laboratory tests * not pregnant as determined by pregnancy screening, nor breast feeding * using acceptable birth control methods. Exclusion Criteria: * History of pregabalin allergy * Use of psychotropic medication antidepressants, antipsychotics DSM-IV axis I diagnosis (schizophrenia, bipolar disorder, major depression * Dependence or abuse of alcohol or any other illicit or prescription drugs * current use of any other tobacco products, including smokeless tobacco * history of seizures * Inability to fulfill all scheduled visits and examination procedures

What they're measuring

We believe this medication will help people to stop smoking

Timeframe: 2 years

Trial details

NCT IDNCT00644137

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-02

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