Tailoring Varenicline to Individual Needs (TVIN Study)

Condition(s) targeted: Tobacco Dependence; Smoking Cessation

Intervention: Varenicline (Drug); Placebo (Drug); Varenicline (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Queen Mary University of London

Official(s) and/or principal investigator(s):
Al-Rehan Abdul Aziz Dhanji, MB.BS., BSc.,MRCS., Principal Investigator, Affiliation: Queen Mary University of London

Overall contact:
Katherine Myers, CPsychol, MSc, BSc, Phone: +44 207 882 8230, Email: k.myers@qmul.ac.uk

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.

Official title: Effects of a Tailored Dose of Varenicline on Post-quitting Urges to Smoke

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Rating of urges to smoke 1-week after the target quit

Secondary outcome:

Identification of the number of people with no effect of varenicline (as measured on a self reported questionnaire) prior to the target quit date

The change of withdrawal symptoms from target quit day over the first 4-weeks of abstinence assessed by the Mood and Physical Symptoms Scale

Validated abstinence rates at 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

Client ratings (measured using a self-reporting questionnaire) of tailored treatment regimen

Rating of urges to smoke 24 hours post target quit date

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Katherine Myers, CPsychol, MSc, BSc, Phone: +44 207 882 8230, Email: k.myers@qmul.ac.uk

Tobacco Dependence Research and Treatment Unit, London E1 2JH, United Kingdom; Recruiting
Katherine Myers, CPsychol MSc, Phone: +44 207 882 8230, Email: k.myers@qmul.ac.uk
Hayden McRobbie, MB, ChB, Phd, Phone: +44 207 882 8246, Email: h.j.Mcrobbie@qmul.ac.uk
Peter Hajek, PhD, Sub-Investigator
Hayden McRobbie, MB, ChB, PhD, Sub-Investigator
Katherine Myers, CPsychol MSc, Sub-Investigator
Al-Rehan Abdul Aziz Dhanji, MB.BS, BSc. MRCS., Principal Investigator

Starting date: July 2011
Last updated: August 24, 2012