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| Sponsor: | Mayo Clinic |
|---|---|
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00578552 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cigarette Smoking Tobacco Use |
Drug: gabapentin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Gabapentin for Smoking Abstinence |
| Enrollment: | 80 |
| Study Start Date: | October 2007 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Mayo Clinic ( Amit Sood, MD ) |
| Study ID Numbers: | 06-005262, 07-000700 |
| Study First Received: | December 19, 2007 |
| Last Updated: | July 31, 2009 |
| ClinicalTrials.gov Identifier: | NCT00578552 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
tobacco smoking gabapentin abstinence |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Gabapentin Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Membrane Transport Modulators Habits Smoking Sensory System Agents |
Therapeutic Uses Analgesics Excitatory Amino Acid Antagonists Tranquilizing Agents Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Pharmacologic Actions Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |