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

NCT ID: NCT01184664

Last Updated: 2012-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tobacco Dependence Smoking Cessation

Keywords

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Smoking cessation Tobacco dependence Varenicline Nicotine Replacement Therapy Combination therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Varenicline + Active Patch

Participants will use varenicline (1mg BD) + an active, 15mg/16hr Nicotine Patch

Group Type EXPERIMENTAL

Nicotine Patch

Intervention Type DRUG

Varenicline + nicotine patch

Varenicline

Intervention Type DRUG

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

Varenicline + Placebo Patch

Participants will use varenicline (1mg BD) + a Placebo Nicotine Patch

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Varenicline + placebo patch

Varenicline

Intervention Type DRUG

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

Interventions

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Nicotine Patch

Varenicline + nicotine patch

Intervention Type DRUG

Placebo

Varenicline + placebo patch

Intervention Type DRUG

Varenicline

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

Intervention Type DRUG

Other Intervention Names

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Champix Chantix Champix Chantix Champix Chantix

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Queen Mary University of London

OTHER

Sponsor Role lead

Responsible Party

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Professor Peter Hajek

Professor of Clinical Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Al-Rehan A A Dhanji, MB BS BSc MRCS

Role: PRINCIPAL_INVESTIGATOR

Queen Mary University of London

Locations

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Tobacco Dependence Research and Treatment Unit

London, , United Kingdom

Site Status

Tobacco Dependence Research Unit

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

Reference Type DERIVED
PMID: 37142273 (View on PubMed)

Hajek P, Smith KM, Dhanji AR, McRobbie H. Is a combination of varenicline and nicotine patch more effective in helping smokers quit than varenicline alone? A randomised controlled trial. BMC Med. 2013 May 29;11:140. doi: 10.1186/1741-7015-11-140.

Reference Type DERIVED
PMID: 23718718 (View on PubMed)

Other Identifiers

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2010-022334-92

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

qmul250510

Identifier Type: -

Identifier Source: org_study_id