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Tobacco DependencePhase 3CONVICTNCT01184664

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

A Phase 3 study testing Nicotine Patch and Varenicline in people with Tobacco Dependence and Smoking Cessation, run by Queen Mary University of London at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tobacco Dependence, Smoking Cessation
What is being tested?
Nicotine Patch and Varenicline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
117 participants
Where
2 sitesUnited Kingdom
Study dates
Apr 2011to Oct 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Tobacco Dependence Research and Treatment Unit

    London, E1 2JH

  • Tobacco Dependence Research Unit

    London, E1 2JH

Other trials in United Kingdom

About this study

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

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.

Being tested
Nicotine Patch, Placebo, Varenicline
Keywords
Smoking cessation, Tobacco dependence, Varenicline, Nicotine Replacement Therapy, Combination therapy
Medical subject headings
Tobacco Use Disorder, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nicotine PatchDrug

    Also called Champix, Chantix

    Varenicline + nicotine patch

  • PlaceboDrug

    Also called Champix, Chantix

    Varenicline + placebo patch

  • VareniclineDrug

    Also called Champix, Chantix

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

Study groups in NCT01184664
Study groupRoleWhat they receive
Varenicline + Active PatchExperimentalParticipants will use varenicline (1mg BD) + an active, 15mg/16hr Nicotine Patch
Receives: Drug: Nicotine Patch; Drug: Varenicline
Varenicline + Placebo PatchPlacebo comparatorParticipants will use varenicline (1mg BD) + a Placebo Nicotine Patch
Receives: Drug: Placebo; Drug: Varenicline

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 week

Secondary outcomes (4)

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

    Measured: 12 weeks post target quit date

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

    Measured: 4-weeks post quitting

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

    Measured: Up to 12-weeks post quitting

  4. 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

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2010 (estimated)
  2. Study startApr 2011
  3. Primary completionOct 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01184664
Sponsor's protocol ID
qmul250510
Other IDs
2010-022334-92
Acronym
CONVICT
Status last verified
Oct 2012
First submitted
17 Aug 2010
Last updated
11 Oct 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 37142273

  • 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.

    PubMed 23718718

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nicotine Patch and Varenicline in people with Tobacco Dependence and Smoking Cessation, run by Queen Mary University of London at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01184664, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2012.

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