Initial Screening of Gemfibrozil as a Novel Treatment for Tobacco Addiction
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Gemfibrozil; Placebo
Intervention description: 600 mg of gemfibrozil (one capsule) twice daily for two weeks.; One lactose pill twice a day for two weeks.
Intervention MeSH terms: Gemfibrozil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Gemfibrozil; Nicotine Dependence; Smoking; Cigarettes

Summary:

      The purpose of this study is to investigate the effect of gemfibrozil on nicotine
      reinforcement and cue-elicited craving. Other objectives of this study include screening for
      the ability of gemfibrozil to aid smoking abstinence during a brief quit attempt and
      examining the validity of using laboratory measures of tobacco dependence to predict smoking
      abstinence. It is hypothesized that gemfibrozil will result in diminished nicotine
      reinforcement, an attenuated response to smoking cues, and an increase in smoking abstinence
      compared with placebo. It is also hypothesized that the laboratory measures will prove valid
      in predicting abstinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  19-65 year old males and females

          -  smoking at least 10 cigarettes per day for at least 2 years

          -  intend to quit smoking within the next 3 months

          -  medically and psychologically healthy as determined by screening criteria

        Exclusion Criteria:

          -  currently attempting to quit smoking

          -  treatment for tobacco addiction in the past 3 months

          -  use of nicotine replacement products, bupropion, or varenicline in the past 3 months
             as an aid to quit or reduce smoking

          -  use of any oral tobacco product in the past 3 months

          -  history of drug or alcohol dependence within last 5 years

          -  consumption of more than 15 alcoholic drinks per week on average during the past month

          -  use of any illicit drug more than once per week on average during the past month

          -  current use of gemfibrozil or other fibrate medication

          -  current use of any medication that is contraindicated for gemfibrozil or that would
             interfere with the protocol in the opinion of MAI/QI. This includes, but is not
             limited to, anticoagulants, statins, other fibrates, other lipid-lowering agents such
             as niacin or herbal remedies, and any oral or injected medications for diabetes.

          -  any pre-existing gall-bladder disease or operation in the past 12 months

          -  any history of or current cardiovascular, liver, hepatic or renal disease

          -  diabetes

          -  pregnant, nursing, or become pregnant during the study

          -  use of psychoactive drugs or medications as revealed by urine toxicology