Tailoring Varenicline to Individual Needs (TVIN Study)

Queen Mary University of London

Status and phase: Completed; Phase 3

Conditions: Tobacco Dependence; Smoking Cessation

Treatments: Drug: Placebo; Drug: Varenicline

Study type: Interventional

Funder types: Other

Identifiers

NCT01206010

2010-022335-11 (EudraCT Number)

qmul010610

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Varenicline + Active Tailored Dose

Experimental group

Treatment:

Drug: Varenicline

Drug: Varenicline

Varenicline + Placebo Tailored Dose

Placebo Comparator group

Treatment:

Drug: Varenicline

Drug: Placebo

Drug: Varenicline