Smoking Cessation Clinical Trial
Official 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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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