Tailoring Varenicline to Individual Needs (TVIN Study)

Phase 3

Completed

• Conditions: Tobacco Dependence; Smoking Cessation
• Interventions: Drug: Varenicline; Drug: Placebo

• Registration Number: NCT01206010
• Lead Sponsor: Queen Mary University of London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2010-09-20
• Study First Posted: 2010-09-21
• Study Start: 2011-07
• Primary Completion: 2012-11
• Study Completion: 2013-02
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-24
• Last Update Posted: 2013-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Varenicline + Active Tailored Dose	Varenicline	-
Varenicline + Placebo Tailored Dose	Placebo	-
Varenicline + Placebo Tailored Dose	Varenicline	-

Primary Outcome Measures

Name	Time	Method
Rating of urges to smoke 1-week after the target quit	1 week	Rating of urges to smoke will be assessed using the Mood \& Physical Symptoms Scale

Secondary Outcome Measures

Name	Time	Method
Rating of urges to smoke 24 hours post target quit date	24 hours post target quit date
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
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
Validated abstinence rates at 1-12 weeks post target quit date	1-12 weeks post target quit date
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
Client ratings (measured using a self-reporting questionnaire) of tailored treatment regimen	Up to 12 weeks post quit

Trial Locations

Locations (1)

Tobacco Dependence Research and Treatment Unit; 🇬🇧 London, United Kingdom