Status:
COMPLETED
GABA (Gamma Amino Butyric Acid) Medication for Tobacco
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
US Department of Veterans Affairs
Conditions:
Nicotine Dependence
Eligibility:
All Genders
18-55 years
Phase:
EARLY_PHASE1
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 sm...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00644137
Start Date
August 1 2007
End Date
February 1 2010
Last Update
April 2 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale University
New Haven, Connecticut, United States, 06520