GABA (Gamma Amino Butyric Acid) Medication for Tobacco

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-02-28

Brief Summary

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The goal of this study is to examine the effects of a GABA (gamma amino butyric acid)-enhancing medication, pregabalin (300 mg/day), on smoking behavior, tobacco withdrawal and cigarette craving in smokers. We hypothesize that in smokers, pregabalin at 300 mg/day, will be more effective than placebo in decreasing smoking behavior and attenuating tobacco withdrawal and cigarette craving.

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Detailed Description

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A total of 40 smokers will be randomly assigned to a sequence of treatment conditions: 300 mg/day pregabalin or placebo treatment. Each treatment condition will last 4 days, separated by 3 to 15 days of washout period. Smokers will have twice daily outpatient visits during the first 3 days and a test session on day 4. In each treatment period, smokers will abstain from smoking for 2.5 days, starting at 10 pm on Day 1 until the test session on Day 4. During the test sessions, measures of smoking behavior and tobacco withdrawal will be obtained.

Smoking is an important public health problem costing over 430,000 lives a year in this county alone. The first line-treatments, Nicotine Replacement Treatments (NRT) or bupropion, compared to placebo, approximately double the long-term success rate for smoking cessation. Given that there remains 46 million smokers in this country and over 70 percent of them interested in quitting smoking, development of new treatments for smoking cessation will have great public health implications.

Currently this protocol is complete with 24 completers. This study has been published. (April 2011)

Conditions

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Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

pregabalin 300mg/day given in conjunction with smoking cigarettes.

Group Type EXPERIMENTAL

pregabalin

Intervention Type DRUG

Help stop smoking

cigarettes

Intervention Type OTHER

help stop smoking with study medication

2

cigarettes given in conjunction with pregabalin

Group Type EXPERIMENTAL

pregabalin

Intervention Type DRUG

Help stop smoking

cigarettes

Intervention Type OTHER

help stop smoking with study medication

Interventions

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pregabalin

Help stop smoking

Intervention Type DRUG

cigarettes

help stop smoking with study medication

Intervention Type OTHER

Other Intervention Names

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300mg/day for pregabalin with smoking cigarettes

Eligibility Criteria

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Inclusion Criteria

* Female and male smokers, aged 18 to 55 years
* History of smoking daily for the past 12 months
* at least 15 cigarettes daily
* In good health as verified by medical history
* screening examination
* screening laboratory tests
* not pregnant as determined by pregnancy screening, nor breast feeding
* using acceptable birth control methods.

Exclusion Criteria

* History of pregabalin allergy
* Use of psychotropic medication antidepressants, antipsychotics DSM-IV axis I diagnosis (schizophrenia, bipolar disorder, major depression
* Dependence or abuse of alcohol or any other illicit or prescription drugs
* current use of any other tobacco products, including smokeless tobacco
* history of seizures
* Inability to fulfill all scheduled visits and examination procedures

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes