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

NCT01184664 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2012-10-11

No results posted yet for this study

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.

Conditions

  • Tobacco Dependence
  • Smoking Cessation

Interventions

DRUG

Nicotine Patch

Varenicline + nicotine patch

DRUG

Placebo

Varenicline + placebo patch

DRUG

Varenicline

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

Sponsors & Collaborators

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Al-Rehan A A Dhanji, MB BS BSc MRCS · Queen Mary University of London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01184664 on ClinicalTrials.gov