Clinical trial NCT01206010: Tailoring Varenicline to Individual Needs (TVIN Study)
Official title: Effects of a Tailored Dose of Varenicline on Post-quitting Urges to Smoke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tobacco Dependence
Smoking Cessation
Keywords: Tobacco Dependence
Smoking cessation
Varenicline
Tailored dosing
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2010-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rating of urges to smoke 1-week after the target quit
timeFrame: 1 week
Secondary outcomes:
measure: Identification of the number of people with no effect of varenicline (as measured on a self reported questionnaire) prior to the target quit date
timeFrame: 2 weeks pre quitting
measure: The change of withdrawal symptoms from target quit day over the first 4-weeks of abstinence assessed by the Mood and Physical Symptoms Scale
timeFrame: 4 weeks post quitting
measure: Validated abstinence rates at 1-12 weeks post target quit date
timeFrame: 1-12 weeks post target quit date
measure: Profile of all adverse effects (as measured by a self reported questionnaire) reported up to 12-weeks post quitting
timeFrame: Up to 12 weeks post quitting
measure: Client ratings (measured using a self-reporting questionnaire) of tailored treatment regimen
timeFrame: Up to 12 weeks post quit
measure: Rating of urges to smoke 24 hours post target quit date
timeFrame: 24 hours post target quit date
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Tobacco Dependence Research and Treatment Unit
Study officials:
affiliation: Queen Mary University of London
name: Al-Rehan Abdul Aziz Dhanji, MB.BS., BSc.,MRCS.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hajek P, McRobbie H, Myers Smith K, Phillips A, Cornwall D, Dhanji AR. Increasing varenicline dose in smokers who do not respond to the standard dosage: a randomized clinical trial. JAMA Intern Med. 2015 Feb;175(2):266-71. doi: 10.1001/jamainternmed.2014.6916.