GABA (Gamma Amino Butyric Acid) Medication for Tobacco

Nicotine Dependence Clinical Trial

Official title:

Pregabalin Given to Tobacco Users to Study Addiction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644137
• Other study ID #: 0701002184
• Secondary ID: R01DA020752VA 00
• Status: Completed
• Phase: Early Phase 1
• Start date: August 2007
• Est. completion date: February 2010

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Drug:
• pregabalin
Help stop smoking

Other:
• cigarettes
help stop smoking with study medication

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA), US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	We believe this medication will help people to stop smoking		2 years