CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Gabapentin - 1800 mg/dayfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00578552
NCT00578552Phase 2Completed

Gabapentin for Smoking Abstinence

Mayo Clinic·interventional·Posted Dec 21, 2007·Updated Apr 19, 2011

In Brief

A Phase 2 clinical trial evaluating Placebo, Gabapentin - 1800 mg/day, and 1 other intervention for Cigarette Smoking and Tobacco Use. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 21, 2007
Enrollment StartOct 1, 2007
Primary CompletionFeb 1, 2009
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.5 years ago

Interventions

Placebodrug

Placebo pill - non active sugar pill designed to look alike to the gabapentin medication

Gabapentin - 1800 mg/daydrug

gabapentin - 1800 mg/day for 12 weeks.

Gabapentin - 2700 mg/daydrug

gabapentin - 2700 mg/day for 12 weeks.