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Tailoring Varenicline to Individual Needs (TVIN Study)

NCT01206010 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-04-25

No results posted yet for this study

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.

Conditions

  • Tobacco Dependence
  • Smoking Cessation

Interventions

DRUG

Varenicline

Participants will increase varenicline dose by 0.5 mg twice daily every three days to a maximum of 2.5 mg twice daily. This increased dose will be continued for 3-weeks before being reduced to the standard dose of 1.0 mg twice daily.

DRUG

Placebo

Participants will increase placebo dose by 0.5 mg twice daily every three days to a maximum of 2.5 mg twice daily. This increased dose will be continued for 3-weeks before being reduced to the standard varenicline dose of 1.0 mg twice daily.

DRUG

Varenicline

All participants will receive the standard dose of Varenicline (14 weeks): 0.5 mg once daily for days 1-3, 0.5 mg twice daily for days 4-7, and then a continuation dose of 1.0 mg twice daily. In addition to this participants will use an tailored varenicline/placebo dose up to maximum of 2.5 mg twice daily for 3 weeks.

Sponsors & Collaborators

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Al-Rehan Abdul Aziz Dhanji, MB.BS., BSc.,MRCS. · Queen Mary University of London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-11-30
Completion
2013-02-28

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01206010 on ClinicalTrials.gov