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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Professor Peter Hajek, Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT01184664
First received: August 17, 2010
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Tobacco Dependence
Smoking Cessation
 Drug: Nicotine Patch
Drug: Placebo
Drug: Varenicline
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Rating of urges to smoke will be assessed using the Mood and Physical Symptoms Scale


Secondary Outcome Measures:
  • Validated abstinence rates over weeks 1-12 post target quit date [ Time Frame: 12 weeks post target quit date ] [ Designated as safety issue: No ]
  • Rating of withdrawal symptoms up to 4-weeks post quitting assessed by Mood and Physical Symptoms Scale [ Time Frame: 4-weeks post quitting ] [ Designated as safety issue: No ]
  • Profile of all adverse effects reported up to 12-weeks post quitting [ Time Frame: Up to 12-weeks post quitting ] [ Designated as safety issue: Yes ]
  • Ratings of urges to smoke 24 hours after the target quit date [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Urges to smoke at 24 hours after the target quit date will be assessed using the Mood & Physical Symptoms Scale


Enrollment: 117
Study Start Date: April 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 17, 2010
Last Updated: October 10, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013