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

Smoking Cessation Clinical Trial

— CONVICT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184664
• Other study ID #: qmul250510
• Secondary ID: 2010-022334-92
• Status: Completed
• Phase: Phase 3
• First received: August 17, 2010
• Last updated: October 10, 2012
• Start date: April 2011
• Est. completion date: October 2011

Study information

• Verified date: October 2012
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Nicotine Patch
Varenicline + nicotine patch
• Placebo
Varenicline + placebo patch
• Varenicline
All participants will receive a standard dose of varenicline (12 weeks).

Locations

Country	Name	City	State
United Kingdom	Tobacco Dependence Research and Treatment Unit	London
United Kingdom	Tobacco Dependence Research Unit	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale	Rating of urges to smoke will be assessed using the Mood and Physical Symptoms Scale	1 week	No
Secondary	Validated abstinence rates over weeks 1-12 post target quit date		12 weeks post target quit date	No
Secondary	Rating of withdrawal symptoms up to 4-weeks post quitting assessed by Mood and Physical Symptoms Scale		4-weeks post quitting	No
Secondary	Profile of all adverse effects reported up to 12-weeks post quitting		Up to 12-weeks post quitting	Yes
Secondary	Ratings of urges to smoke 24 hours after the target quit date	Urges to smoke at 24 hours after the target quit date will be assessed using the Mood & Physical Symptoms Scale	24 hours	No