GABA (Gamma Amino Butyric Acid) Medication for Tobacco

March 31, 2020 updated by: Yale University

Pregabalin Given to Tobacco Users to Study Addiction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
pregabalin 300mg/day given in conjunction with smoking cigarettes.
Drug: pregabalin
Help stop smoking
Other Names:
  • 300mg/day for pregabalin with smoking cigarettes
Other: cigarettes
help stop smoking with study medication
Experimental: 2
cigarettes given in conjunction with pregabalin
Drug: pregabalin
Help stop smoking
Other Names:
  • 300mg/day for pregabalin with smoking cigarettes
Other: cigarettes
help stop smoking with study medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
We believe this medication will help people to stop smoking
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)
US Department of Veterans Affairs

Investigators

  • Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D., Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

March 24, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Actual)

April 2, 2020

Last Update Submitted That Met QC Criteria

March 31, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0701002184
  • DPMC (Other Identifier: NIDA)
  • R01DA020752 (U.S. NIH Grant/Contract)
  • VA 0023 (Registry Identifier: VA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe