Smoking Cessation Clinical Trial
— CONVICTOfficial title:
Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke
Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation treatments. Anecdotally smokers who are finding their quit attempt difficult have reported benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled double-blind study will examine whether combining NRT and varenicline provides better withdrawal and craving relief than varenicline alone. A total of 120 smokers would be randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All participants will receive standard NHS Stop Smoking Service support. The primary outcome would be ratings of craving and withdrawal discomfort 24 hours and one week after the target quit date.
Status | Completed |
Enrollment | 117 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Smokers seeking treatment - Aged 18 and over - Consenting to take part in the trial Exclusion Criteria: - Pregnant or breastfeeding - End-stage renal disease - Unable to fill in questionnaires in English - Previous allergy to Varenicline - Previous allergy to Nicotine Patches Previous allergy to varenicline |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Tobacco Dependence Research and Treatment Unit | London | |
United Kingdom | Tobacco Dependence Research Unit | London |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale | Rating of urges to smoke will be assessed using the Mood and Physical Symptoms Scale | 1 week | No |
Secondary | Validated abstinence rates over weeks 1-12 post target quit date | 12 weeks post target quit date | No | |
Secondary | Rating of withdrawal symptoms up to 4-weeks post quitting assessed by Mood and Physical Symptoms Scale | 4-weeks post quitting | No | |
Secondary | Profile of all adverse effects reported up to 12-weeks post quitting | Up to 12-weeks post quitting | Yes | |
Secondary | Ratings of urges to smoke 24 hours after the target quit date | Urges to smoke at 24 hours after the target quit date will be assessed using the Mood & Physical Symptoms Scale | 24 hours | No |
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