At a glance
ClinicalIndex Comparison Record- ✓Women aged 18-65 years
- ✓Smoking ≥10 cigarettes/day in past 6 months with exhaled CO >10 ppm at enrollment
- ✓DSM-IV criteria for current Nicotine Dependence satisfied
- ✓Willing to take study medication and motivated to quit smoking with willingness to set quit date within 2 weeks
- ✕Pregnant or able to become pregnant without approved contraception
- ✕Severe unstable medical illness (cardiovascular, hepatic, renal, respiratory, metabolic, neurological, hematological) likely requiring hospitalization within 2 months
- ✕Life-threatening arrhythmia, cerebrovascular or cardiovascular event within 6 months
- ✕Use of tobacco products other than cigarettes (cigar, pipe)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Placebo-Controlled Trial of the NMDA Glycine Site Antagonist, GW468816, for Prevention of Relapse to Smoking
In Brief
A Phase 2 clinical trial evaluating GW468816 and Placebo Comparator: Placebo for Nicotine Dependence. Completed, enrolled 264 participants across 2 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy of the glycine antagonist, GW468816, compared with placebo on duration of abstinence and rates of relapse in recently quit female smokers in a randomized, double-blind, five-week clinical trial. According to the investigators, the new medication, GW468816, is thought to send certain signals in the brain that may be effective in helping people stay abstinent after they have recently quit smoking. GW468816 is a non-nicotine drug. The investigators of this study hypothesize that subjects receiving GW468816 will demonstrate a significantly longer time to relapse to smoking than those in the placebo group, as measured by the primary outcome measure (see below).
Study Details
Timeline
Interventions
Pharmacotherapies for Relapse Prevention