GABA (Gamma Amino Butyric Acid) Medication for Tobacco

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: gamma-Aminobutyric Acid; Pregabalin

Criteria

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