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NCT Number: NCT01184664

Combination of Nicotine Replacement Therapy (NRT) and Varenicline to Increase Cessation of Tobacco (CONVICT Study)

Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation treatments. Anecdotally smokers who are finding their quit attempt difficult have reported benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled double-blind study will examine whether combining NRT and varenicline provides better withdrawal and craving relief than varenicline alone. A total of 120 smokers would be randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All participants will receive standard NHS Stop Smoking Service support. The primary outcome would be ratings of craving and withdrawal discomfort 24 hours and one week after the target quit date.

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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 Unit, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Smokers seeking treatment
  • Aged 18 and over
  • Consenting to take part in the trial

Exclusion criteria

  • Pregnant or breastfeeding
  • End-stage renal disease
  • Unable to fill in questionnaires in English
  • Previous allergy to Varenicline
  • Previous allergy to Nicotine Patches Previous allergy to varenicline

Treatment and study plan

Nicotine patch

Drug

Varenicline + nicotine patch

Other names: Champix, Chantix

Placebo

Drug

Varenicline + placebo patch

Other names: Champix, Chantix

Varenicline

Drug

All participants will receive a standard dose of varenicline (12 weeks).

Other names: Champix, Chantix

Primary outcomes

  1. Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale

    Time frame: 1 week

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

Secondary outcomes

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

    Time frame: 12 weeks post target quit date

  2. Rating of withdrawal symptoms up to 4-weeks post quitting assessed by Mood and Physical Symptoms Scale

    Time frame: 4-weeks post quitting

  3. Profile of all adverse effects reported up to 12-weeks post quitting

    Time frame: Up to 12-weeks post quitting

  4. Ratings of urges to smoke 24 hours after the target quit date

    Time frame: 24 hours

    Urges to smoke at 24 hours after the target quit date will be assessed using the Mood & Physical Symptoms Scale

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study title

Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke

Acronym: CONVICT

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 19, 2010
Registry last updated
Oct 11, 2012

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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