Gabapentin for Smoking Cessation
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|ClinicalTrials.gov Identifier: NCT00578552|
Recruitment Status : Completed
First Posted : December 21, 2007
Results First Posted : December 1, 2010
Last Update Posted : April 19, 2011
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 or disease||Intervention/treatment||Phase|
|Cigarette Smoking Tobacco Use||Drug: Placebo Drug: Gabapentin - 1800 mg/day Drug: Gabapentin - 2700 mg/day||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Gabapentin for Smoking Abstinence|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||May 2009|
Placebo Comparator: Placebo
Non active placebo pill
Placebo pill - non active sugar pill designed to look alike to the gabapentin medication
Active Comparator: Gabapentin - 1800 mg/day
Gabapentin - 1800 mg/day
Drug: Gabapentin - 1800 mg/day
gabapentin - 1800 mg/day for 12 weeks.
Other Name: gabapentin
Active Comparator: Gabapentin - 2700 mg/day
Gabapentin - 2700 mg/day
Drug: Gabapentin - 2700 mg/day
gabapentin - 2700 mg/day for 12 weeks.
Other Name: gabapentin
- Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco [ Time Frame: 12 weeks following start of medication ]Point prevalence tobacco abstinence was adjudicated if the following conditions were met: (a) self-reported tobacco abstinence for the previous 7 days with a negative response to the question "Have you used any type of tobacco, even a puff, in the past 7 days?" and (b) Expired Carbon Monoxide equal or less then 8 parts per million.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578552
|United States, Minnesota|
|Mayo Clinic Nicotine Research Program|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Amit Sood, MD||Mayo Clinic|