GABA (Gamma Amino Butyric Acid) Medication for Tobacco

Yale University

Status and phase

Completed

Early Phase 1

Conditions

Nicotine Dependence

Treatments

Drug: pregabalin

Other: cigarettes

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

NIH

Identifiers

NCT00644137

0701002184

VA 0023 (Registry Identifier)

R01DA020752 (U.S. NIH Grant/Contract)

DPMC

Details and patient eligibility

About

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.

Full description

A total of 40 smokers will be randomly assigned to a sequence of treatment conditions: 300 mg/day pregabalin or placebo treatment. Each treatment condition will last 4 days, separated by 3 to 15 days of washout period. Smokers will have twice daily outpatient visits during the first 3 days and a test session on day 4. In each treatment period, smokers will abstain from smoking for 2.5 days, starting at 10 pm on Day 1 until the test session on Day 4. During the test sessions, measures of smoking behavior and tobacco withdrawal will be obtained.

Smoking is an important public health problem costing over 430,000 lives a year in this county alone. The first line-treatments, Nicotine Replacement Treatments (NRT) or bupropion, compared to placebo, approximately double the long-term success rate for smoking cessation. Given that there remains 46 million smokers in this country and over 70 percent of them interested in quitting smoking, development of new treatments for smoking cessation will have great public health implications.

Currently this protocol is complete with 24 completers. This study has been published. (April 2011)

Enrollment

24 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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