GABA (Gamma Amino Butyric Acid) Medication for Tobacco

Early Phase 1

Completed

• Conditions: Nicotine Dependence
• Interventions: Drug: pregabalin; Other: cigarettes

• Registration Number: NCT00644137
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

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)

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-03-24
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-26
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	cigarettes	pregabalin 300mg/day given in conjunction with smoking cigarettes.
2	pregabalin	cigarettes given in conjunction with pregabalin
2	cigarettes	cigarettes given in conjunction with pregabalin
A	pregabalin	pregabalin 300mg/day given in conjunction with smoking cigarettes.

Primary Outcome Measures

Name	Time	Method
We believe this medication will help people to stop smoking	2 years

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States