Phase 2
Completed N=98
Effectiveness of GW468816, an NMDA Glycine Site Antagonist, for Prevention of Relapse to Smoking
Source: ClinicalTrials.gov NCT00218465 ↗Enrolled (actual)
98
Serious AEs
3.1%
Results posted
Dec 2010
Primary outcomePrimary: Time to Relapse to Smoking in the 5-week Relapse Prevention Phase. — 14.5; 12.4 days
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Relapse to Smoking in the 5-week Relapse Prevention Phase. |
14.5; 12.4 | — |
| PRIMARY Number of Abstinent and Nonabstinent Participants at End of 5 Week Placebo-controlled Relapse Prevention Trial |
50; 48 | — |
| PRIMARY Days to Relapse Within the 60 Days Following Randomization |
20.8; 20.6 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent
- WOMEN aged 18-65 years, inclusive
- Self-report of smoking 10 or more cigarettes per day in the past 6 months and expired air CO >10 ppm at the time of enrollment
- DSM-IV criteria for current Nicotine Dependence satisfied
- Subjects must be willing to take the study medication and be motivated to quit smoking (willing to set a quit date within 2 weeks of entry into the protocol)
- Women of childbearing potential must have a negative urine pregnancy test (quantitative HCG) at baseline and at week 8, prior to receiving the first dose of study medication and females must agree to use an approved form of contraception from the day of the first dose of study medication for 90 days after the last dose of study medication. Approved forms of contraception include any of the following:
- Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, through the treatment phase and for 90 days after discontinuation of study medication.
- Sterilization of male partner
- Implant of levonorgestrel
- Injectable progesterone
- Intrauterine device (IUD) with 21 mg per day patch (or equivalent dose of gum, inhaler, nasal spray, or lozenge) for at least 4 weeks.
- History of multiple adverse drug reactions
- Use of an investigational drug or device within 4 weeks of enrollment
- Concurrently enrolled in a study that involves exposure to a drug or device.
- Urine positive for drugs of abuse at screening visit.
- Use of statins during the period of the investigation.
Data sourced from ClinicalTrials.gov (NCT00218465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.