NCT01184664

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 11, 2012

Status Verified

October 1, 2012

Enrollment Period

6 months

First QC Date

August 17, 2010

Last Update Submit

October 10, 2012

Conditions

Tobacco DependenceSmoking Cessation

Keywords

Smoking cessationTobacco dependenceVareniclineNicotine Replacement TherapyCombination therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Validated abstinence rates over weeks 1-12 post target quit date

    12 weeks post target quit date

  • Rating of withdrawal symptoms up to 4-weeks post quitting assessed by Mood and Physical Symptoms Scale

    4-weeks post quitting

  • Profile of all adverse effects reported up to 12-weeks post quitting

    Up to 12-weeks post quitting

  • Ratings of urges to smoke 24 hours after the target quit date

    24 hours

Study Arms (2)

Varenicline + Active Patch

EXPERIMENTAL

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

Drug: Nicotine PatchDrug: Varenicline

Varenicline + Placebo Patch

PLACEBO COMPARATOR

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

Drug: PlaceboDrug: Varenicline

Interventions

Nicotine PatchDRUG

Varenicline + nicotine patch

Also known as: Champix, Chantix
Varenicline + Active Patch
PlaceboDRUG

Varenicline + placebo patch

Also known as: Champix, Chantix
Varenicline + Placebo Patch
VareniclineDRUG

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

Also known as: Champix, Chantix
Varenicline + Active PatchVarenicline + Placebo Patch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smokers seeking treatment
  • Aged 18 and over
  • Consenting to take part in the trial

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tobacco Dependence Research and Treatment Unit

London, E1 2JH, United Kingdom

Location

Tobacco Dependence Research Unit

London, E1 2JH, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 37142273DERIVED

  • 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.

    PMID: 23718718DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderSmoking Cessation

Interventions

Tobacco Use Cessation DevicesVarenicline

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Officials

  • Al-Rehan A A Dhanji, MB BS BSc MRCS

    Queen Mary University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Psychology

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 19, 2010

Study Start

April 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 11, 2012

Record last verified: 2012-10

Locations

GB(2)