GABA (Gamma Amino Butyric Acid) Medication for Tobacco - Full Text View

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) Yale University Department of Veterans Affairs
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00644137

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

MedlinePlus related topics: Smoking

Drug Information available for: gamma-Aminobutyric Acid Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment
Official Title:	GABA Medication for Tobacco

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	August 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental pregabalin 300mg/day given in conjunction with smoking cigarettes.	Drug: pregabalin Help stop smoking
2: Experimental 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 we have screened 13 subjects with 10 completers. This study is currently recruiting human subjects. Study is still active.

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

Contacts

Contact: Lance Barnes	203-937-4823	lance.barnes@yale.edu
Contact: Stacy Minnix, B.S.W	203-937-4805	stacy.minnix@yale.edu

Locations

United States, Connecticut
Yale University	Recruiting
New Haven, Connecticut, United States, 06520
Contact: Mehmet Sofuoglu, M.D., Ph.D. 203-937-4809 mehmet.sofuoglu@yale.edu
Contact: James Poling, Ph.D. 203-937-4830 james.poling@yale.edu

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Yale University

Department of Veterans Affairs

Investigators

Principal Investigator:

Mehmet Sofuoglu, M.D., Ph.D.

Yale University

More Information

No publications provided

Responsible Party:	Yale University ( Mehmet Sofuoglu M.D., Ph.D. )
Study ID Numbers:	R01 DA020752, YALE 0701002184, VA 0023
Study First Received:	March 24, 2008
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00644137
Health Authority:	United States: Federal Government; United States: Data Safety Monitoring Board through the Department of Veterans Affairs

Keywords provided by National Institute on Drug Abuse (NIDA):

smoking sensations
no cravings
desire to smoke

Study placed in the following topic categories:

Smoking
Mental Disorders
Tobacco Use Disorder
Gamma-Aminobutyric Acid

Substance-Related Disorders
Pregabalin
Disorders of Environmental Origin

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
GABA Agents

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009