GABA (Gamma Amino Butyric Acid) Medication for Tobacco
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||GABA Medication for Tobacco|
- We believe this medication will help people to stop smoking [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2007|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
pregabalin 300mg/day given in conjunction with smoking cigarettes.
Help stop smoking
Other Name: 300mg/day for pregabalin with smoking cigarettes
cigarettes with study medication
help stop smoking with study medication
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644137
|United States, Connecticut|
|New Haven, Connecticut, United States, 06520|
|Principal Investigator:||Mehmet Sofuoglu, M.D., Ph.D.||Yale University|