The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers
A total of 20 subjects will participate in this four week, between groups, double-blind, placebo controlled study. Subjects will participate in two experimental sessions separated by approximately one week. Subjects will be randomized to receive either 50 mg cycloserine or placebo combined with cue exposure. Several physiological and subjective outcome measures (e.g., heart rate, blood pressure, galvanic skin response) will be obtained during the sessions. Experimental sessions will last approximately 4.5 hours with follow-up sessions lasting approximately thirty minutes. Our aims are:
To examine the effect of cycloserine vs. placebo on extinction of smoking cue reactivity in overnight abstinent smokers. Reactivity to smoking cues will be captured with self-report smoking urges and physiological measures (heart rate, blood pressure, and skin conductance).
We hypothesize that cycloserine, relative to placebo, will facilitate extinction of smoking cue reactivity.
- To examine the effect of cycloserine vs. placebo when combined with two 4.5 hour laboratory cue exposure training sessions, on smoking behavior in smokers. Smoking behavior will be measured with self-report smoking and saliva cotinine levels.
- To examine the effect of cycloserine vs. placebo on memory performance in nicotine dependent smokers. Memory performance will be measured with verbal learning, recognition and recall tasks.
4) To examine the safety and tolerability of cycloserine treatment in smokers. We hypothesize that cycloserine will be well tolerated by smokers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers.|
- Cigarettes Smoked Per Day [ Time Frame: 1 week follow-up ] [ Designated as safety issue: No ]The number of cigarettes smoked per day at the 1 week follow up time point.
- Cigarettes Smoked Per Day [ Time Frame: 4 Week Followup ] [ Designated as safety issue: No ]The number of cigarettes smoked per day at the 4-week follow up timepoint.
- Urinary Cotinine Level [ Time Frame: 4 Week Follow-up Timepoint ] [ Designated as safety issue: No ]Urinary Cotinine level at the 4-week follow up timepoint
|Study Start Date:||December 2006|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
50 mg cycloserine
50 mg Cycloserine given in two separate experimental sessions separated by approximately one week.
Sham Comparator: Placebo
Matched placebo for subjects randomized to placebo arm. Given in two experimental sessions separated by approximately one week.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633256
|United States, Connecticut|
|West Haven VA|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||James Poling, Ph.D.||Yale University|