GABA (Gamma Amino Butyric Acid) Medication for Tobacco

Condition(s) targeted: Nicotine Dependence

Intervention: pregabalin (Drug); cigarettes (Other)

Phase: N/A

Status: Recruiting

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
Mehmet Sofuoglu, M.D., Ph.D., Principal Investigator, Affiliation: Yale University

Overall contact:
Lance Barnes, Phone: 203-937-4823, Email: lance.barnes@yale.edu

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.

Official title: GABA Medication for Tobacco

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment

Primary outcome: We believe this medication will help people to stop smoking

Detailed 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 we have screened 13 subjects with 10 completers. This study is currently recruiting human subjects. Study is still active.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Lance Barnes, Phone: 203-937-4823, Email: lance.barnes@yale.edu

Yale University, New Haven, Connecticut 06520, United States; Recruiting
Mehmet Sofuoglu, M.D., Ph.D., Phone: 203-937-4809, Email: mehmet.sofuoglu@yale.edu
James Poling, Ph.D., Phone: 203-937-4830, Email: james.poling@yale.edu

Starting date: August 2007
Ending date: January 2010
Last updated: August 22, 2008