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Top of web page Study summary Study style Arms and also Interventions Outcome procedures Eligibility Criteria Contacts and Locations more Information
Gabapentin is an anti-epileptic agent the has presented preliminary evidence of efficacy for improving symptoms of cocaine and also alcohol tap the money in pilot studies. Due to the fact that the neurobiology the alcohol, cocaine and also nicotine tap the money is similar, the preliminary proof of efficacy the gabapentin for symptoms that alcohol and cocaine withdrawal suggests, that gabapentin might likely aid nicotine withdrawal symptoms and thus tobacco abstinence. The effect of gabapentin on 2 of the neurotransmitters, gamma-aminobutyric acid (GABA) and glutamate additional suggest a potential therapeutic system for gabapentin in tobacco abstinence. However, the precise mechanism of activity of gabapentin is at this time not known. We have recently perfect an open label pilot psychological of gabapentin because that tobacco abstinence including 50 smokers. The findings from the study administer promising preliminary results and also suggest the further experimentation of gabapentin for helping cigarette smokers stop tobacco usage is worth pursuing. Overall, gabapentin is well tolerated and has short abuse potential.
Our goal is to evaluate novel, safe, acceptable, and also effective therapies that may assist increase tobacco abstinence rates. Currently, no randomized trials trial and error the efficacy the gabapentin for cigarette smoking abstinence have been published. While our previous study provides promising evidence about the potential efficacy the gabapentin for smoking cigarettes abstinence, secondary dose ranging study is needed prior to follow a big randomized trial. The primary aim that the dose ranging study will certainly be come obtain extr evidence that efficacy, and information ~ above the optimal dose of gabapentin to rental in the bigger randomized managed trial.
|Cigarette smoking Tobacco usage||Drug: Placebo Drug: Gabapentin - 1800 mg/day Drug: Gabapentin - 2700 mg/day||phase 2|
A full of 120 participants will be recruited in this study and randomly assigned to among the three groups. Entrants in team A will get gabapentin 1800-mg/day orally because that 12-weeks when participants in group B will obtain gabapentin 2700-mg/day orally for 12-weeks. Attendees in team C will receive a matching placebo because that the very same duration. We have actually selected this sheep regimen based on our endure with utilizing gabapentin in the pilot study. The current 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 get a brief behavior counseling intervention throughout participation in the study.
Top of web page Study description Study design Arms and Interventions Outcome procedures Eligibility Criteria Contacts and also Locations much more Information
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|Study kind :||Interventional (Clinical Trial)|
|ActualEnrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||twin (Participant, treatment Provider)|
|Official Title:||Gabapentin for smoking Abstinence|
|examine Start date :||October 2007|
|Actual main Completion day :||February 2009|
|Actual study Completion day :||May 2009|