GABA (Gamma Amino Butyric Acid) Medication for Tobacco

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
ClinicalTrials.gov Identifier:
NCT00644137
First received: March 24, 2008
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Nicotine Dependence
Drug: pregabalin
Other: cigarettes
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: GABA Medication for Tobacco

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • We believe this medication will help people to stop smoking [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: August 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
pregabalin 300mg/day given in conjunction with smoking cigarettes.
Drug: pregabalin
Help stop smoking
Other Name: 300mg/day for pregabalin with smoking cigarettes
Experimental: 2
cigarettes with study medication
Other: cigarettes
help stop smoking with study medication

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)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644137

Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Mehmet Sofuoglu, Principle Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00644137     History of Changes
Other Study ID Numbers: R01 DA020752, R01DA020752, Yale 0701002184, VA 0023, DPMC
Study First Received: March 24, 2008
Last Updated: July 24, 2012
Health Authority: United States: Federal Government

Keywords provided by Yale University:
smoking sensations
no cravings
desire to smoke

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Gamma-Aminobutyric Acid
Pregabalin
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on April 15, 2014