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.
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
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.
- 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.
- 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