Smoking Cessation Clinical Trial
— TVINOfficial title:
Effects of a Tailored Dose of Varenicline on Post-quitting Urges to Smoke
Varenicline is a partial nicotinic agonist which acts on alpha4 beta2 nicotinic receptors.
It is presumed to alleviate withdrawal discomfort, but also to diminish rewarding effects of
cigarettes. The standard varenicline dosing has been formulated to avoid adverse reactions
(primarily nausea) in sensitive clients. The downside of this cautious approach is that a
substantial proportion of clients may be under-dosed. A blanket dose increase would
inevitably increase the incidence of side effects, but it is likely that tailoring
varenicline dosing to clients' needs would be safe and may further increase varenicline's
efficacy.
This study will recruit 200 smokers who report little change to their enjoyment of
cigarettes and no nausea, during the first week of varenicline use. These smokers will be
randomised to receive the standard dose plus placebo or plus individualised varenicline dose
up to 5mg, titrated over the next week prior to their target quit day. Urges to smoke, and
other withdrawal symptoms, experienced during the study period will be compared between
groups to see if the tailored therapy may be useful.
Status | Completed |
Enrollment | 200 |
Est. completion date | February 2013 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Smoker seeking treatment - Aged 18 and over - Consenting to take part - Report little or no change in enjoyment of cigarettes and/or nausea Exclusion Criteria: - Pregnant or breastfeeding - Have severe kidney disease - Have severe heart problems - Have a current psychiatric illness - Are unable to fill in questionnaires in English - Have an allergy to varenicline - Are currently involved in another clinical trial |
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 |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rating of urges to smoke 1-week after the target quit | Rating of urges to smoke will be assessed using the Mood & Physical Symptoms Scale | 1 week | No |
Secondary | Identification of the number of people with no effect of varenicline (as measured on a self reported questionnaire) prior to the target quit date | 2 weeks pre quitting | No | |
Secondary | The change of withdrawal symptoms from target quit day over the first 4-weeks of abstinence assessed by the Mood and Physical Symptoms Scale | 4 weeks post quitting | No | |
Secondary | Validated abstinence rates at 1-12 weeks post target quit date | 1-12 weeks post target quit date | No | |
Secondary | Profile of all adverse effects (as measured by a self reported questionnaire) reported up to 12-weeks post quitting | Up to 12 weeks post quitting | Yes | |
Secondary | Client ratings (measured using a self-reporting questionnaire) of tailored treatment regimen | Up to 12 weeks post quit | No | |
Secondary | Rating of urges to smoke 24 hours post target quit date | 24 hours post target quit date | No |
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