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Completed

NCT Number: NCT01206010

Tailoring Varenicline to Individual Needs (TVIN Study)

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.

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Key information

Conditions

Tobacco Dependence Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Cessation Substance-Related Disorders Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tobacco Dependence Research and Treatment Unit

London, E1 2JH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varenicline

Drug

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.

Other names: Champix, Chantix

Placebo

Drug

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.

Other names: Champix, Chantix

Primary outcomes

  1. Rating of urges to smoke 1-week after the target quit

    Time frame: 1 week

    Rating of urges to smoke will be assessed using the Mood & Physical Symptoms Scale

Secondary outcomes

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

    Time frame: 2 weeks pre quitting

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

    Time frame: 4 weeks post quitting

  3. Validated abstinence rates at 1-12 weeks post target quit date

    Time frame: 1-12 weeks post target quit date

  4. Profile of all adverse effects (as measured by a self reported questionnaire) reported up to 12-weeks post quitting

    Time frame: Up to 12 weeks post quitting

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

    Time frame: Up to 12 weeks post quit

  6. Rating of urges to smoke 24 hours post target quit date

    Time frame: 24 hours post target quit date

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study title

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

Acronym: TVIN

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Sep 21, 2010
Registry last updated
Apr 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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