GABA (Gamma Amino Butyric Acid) Medication for Tobacco

Completed · Early Phase 1

Conditions studied: Nicotine Dependence

In brief

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.

Key facts

Study ID

NCT00644137

Run by

Yale University

People needed

24

Starts

2007-08-01

Expected to finish

2010-02-01

Last updated by the study team

2020-04-02

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Yale University — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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