Gabapentin for Smoking Cessation
Condition: Cigarette Smoking; Tobacco Use
Study type: Interventional
Phase: Phase 2

Summary: 
      Gabapentin is an anti-epileptic agent that has shown preliminary evidence of efficacy for
      improving symptoms of cocaine and alcohol withdrawal in pilot studies. Since the neurobiology
      of alcohol, cocaine and nicotine withdrawal is similar, the preliminary evidence of efficacy
      of gabapentin for symptoms of alcohol and cocaine withdrawal suggests, that gabapentin might
      likely help nicotine withdrawal symptoms and thus tobacco abstinence. The effect of
      gabapentin on two of the neurotransmitters, gamma-aminobutyric acid (GABA) and glutamate
      further suggest a potential therapeutic mechanism for gabapentin in tobacco abstinence.
      However, the exact mechanism of action of gabapentin is currently not known. We have recently
      completed an open label pilot trial of gabapentin for tobacco abstinence involving 50
      smokers. The findings from that study provide promising preliminary results and suggest that
      further testing of gabapentin for helping cigarette smokers quit tobacco use is worth
      pursuing. Overall, gabapentin is well tolerated and has low abuse potential.

      Our goal is to evaluate novel, safe, acceptable, and effective therapies that may help
      increase tobacco abstinence rates. Currently, no randomized trials testing the efficacy of
      gabapentin for smoking abstinence have been published. While our previous study provides
      promising evidence regarding the potential efficacy of gabapentin for smoking abstinence, an
      additional dose ranging study is needed prior to pursuing a large randomized trial. The
      primary aim of the dose ranging study will be to obtain additional evidence of efficacy, and
      information on the optimal dose of gabapentin to employ in the larger randomized controlled
      trial.
    

Detailed description: 
      A total of 120 participants will be recruited in this study and randomly assigned to one of
      the three groups. Participants in group A will receive gabapentin 1800-mg/day orally for
      12-weeks while participants in group B will receive gabapentin 2700-mg/day orally for
      12-weeks. Participants in group C will receive a matching placebo for the same duration. We
      have selected this dose regimen based on our experience with using gabapentin in the pilot
      study. The present study is designed as a randomized, blinded, placebo-controlled, three-arm,
      parallel-group, dose-ranging, phase II clinical trial. In addition to receiving gabapentin or
      placebo, all subjects will receive a brief behavioral counseling intervention during
      participation in the study.
    

Intervention name(s): Placebo; Gabapentin - 1800 mg/day; Gabapentin - 2700 mg/day
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo pill - non active sugar pill designed to look alike to the gabapentin medication; gabapentin - 1800 mg/day for 12 weeks.; gabapentin - 2700 mg/day for 12 weeks.
Other intervention name(s): gabapentin; gabapentin
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: tobacco; smoking; gabapentin; abstinence