Gabapentin for Smoking Cessation

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.

Inclusion criteria

• Are between 18 to 65 years of age
• Have smoked ≥10 cigarettes/day for the past 1 year or more
• Are willing to make a quit attempt
• Are able to participate fully in all aspects of the study; and
• Have been provided with, understand, and have signed the informed consent.

Exclusion criteria

• Meet diagnostic criteria for current major depressive disorder or lifetime history of bipolar disorder or schizophrenia. Patients with mild or moderate depressive symptoms as assessed by the CES-D and determined by the physician, but who do not meet current diagnostic criteria for major depressive disorder, will be included
• Are currently (within past 30 days) using antipsychotics, or antidepressants
• Are currently (in previous 30 days) using any tobacco treatment program (i.e., behavioral therapy, nicotine replacement therapy, bupropion SR, clonidine, or nortriptyline)
• Have used an investigational drug within the 30 days prior to enrolling in this study
• Have recent history (in the past year) of alcohol abuse or dependence as assessed by the CAGE questionnaire and study investigators
• Have a recent history of drug abuse as assessed by the Drug Abuse Screening Test 20 (DAST-20) and physician interview
• Are pregnant, lactating, or of child bearing potential, likely to become pregnant during the medication phase and not willing to use contraception. The following birth control measures are acceptable: birth control pills, approved intra-uterine contraceptive devices, the use of two combined barrier methods (diaphragm with spermicide or condom with spermicide), injections, surgical sterilization and abstinence
• Have a history of any major cardio-vascular events in the past 6 months including unstable angina, acute MI or coronary angioplasty
• Have clinically significant acute or chronic progressive or unstable neurologic (myasthenia gravis), hepatic, renal, cardiovascular, respiratory (bronchospastic disease) or metabolic disease
• Are currently on the following prescribed medications known to interact with gabapentin and unable to stop them during the study: Maalox®, cimetidine and morphine. Patients will be cautioned not to use sedatives (such as benzodiazepines, antihistamines, anti-cholinergics, trazodone, zaleplon, anti-psychotics, barbiturates, opiates, zolpidem and eszopiclone) during the study
• Have another house-hold member or relative participating in the study
• Have known allergy to gabapentin or its constituents; and
• Are professional drivers or operators of heavy machinery and unable to refrain from these activities during the medication phase of the study.