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

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ClinicalTrials.gov Identifier: NCT01184664
Recruitment Status : Completed
First Posted : August 19, 2010
Last Update Posted : October 11, 2012
Sponsor:
Information provided by (Responsible Party):
Professor Peter Hajek, Queen Mary University of London

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tobacco Dependence Smoking Cessation Drug: Nicotine Patch Drug: Placebo Drug: Varenicline Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke
Study Start Date : April 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Varenicline + Active Patch
Participants will use varenicline (1mg BD) + an active, 15mg/16hr Nicotine Patch
Drug: Nicotine Patch
Varenicline + nicotine patch
Other Names:
  • Champix
  • Chantix

Drug: Varenicline
All participants will receive a standard dose of varenicline (12 weeks).
Other Names:
  • Champix
  • Chantix

Placebo Comparator: Varenicline + Placebo Patch
Participants will use varenicline (1mg BD) + a Placebo Nicotine Patch
Drug: Placebo
Varenicline + placebo patch
Other Names:
  • Champix
  • Chantix

Drug: Varenicline
All participants will receive a standard dose of varenicline (12 weeks).
Other Names:
  • Champix
  • Chantix




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184664


Locations
United Kingdom
Tobacco Dependence Research and Treatment Unit
London, United Kingdom, E1 2JH
Tobacco Dependence Research Unit
London, United Kingdom, E1 2JH
Sponsors and Collaborators
Queen Mary University of London
Investigators
Principal Investigator: Al-Rehan A A Dhanji, MB BS BSc MRCS Queen Mary University of London

Responsible Party: Professor Peter Hajek, Professor of Clinical Psychology, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01184664     History of Changes
Other Study ID Numbers: qmul250510
2010-022334-92 ( EudraCT Number )
First Posted: August 19, 2010    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012

Keywords provided by Professor Peter Hajek, Queen Mary University of London:
Smoking cessation
Tobacco dependence
Varenicline
Nicotine Replacement Therapy
Combination therapy

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action