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Tobacco DependencePhase 3TVINNCT01206010

Tailoring Varenicline to Individual Needs (TVIN Study)

A Phase 3 study testing Varenicline in people with Tobacco Dependence and Smoking Cessation, run by Queen Mary University of London at 1 site 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 is a partial nicotinic agonist which acts on alpha4 beta2 nicotinic receptors. It is presumed to alleviate withdrawal discomfort, but also to diminish rewarding effects of cigarettes. The standard varenicline dosing has been formulated to avoid adverse reactions (primarily nausea) in sensitive clients. 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?
Varenicline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteUnited Kingdom
Study dates
Jul 2011to Feb 2013
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

  • Smoker seeking treatment
  • Aged 18 and over
  • Consenting to take part
  • Report little or no change in enjoyment of cigarettes and/or nausea

Who cannot join

  • Pregnant or breastfeeding
  • Have severe kidney disease
  • Have severe heart problems
  • Have a current psychiatric illness
  • Are unable to fill in questionnaires in English
  • Have an allergy to varenicline
  • Are currently involved in another clinical trial

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Tobacco Dependence Research and Treatment Unit

    London, E1 2JH

Other trials in United Kingdom

About this study

Official title: Effects of a Tailored Dose of Varenicline on Post-quitting Urges to Smoke

Varenicline is a partial nicotinic agonist which acts on alpha4 beta2 nicotinic receptors. It is presumed to alleviate withdrawal discomfort, but also to diminish rewarding effects of cigarettes. The standard varenicline dosing has been formulated to avoid adverse reactions (primarily nausea) in sensitive clients. The downside of this cautious approach is that a substantial proportion of clients may be under-dosed. A blanket dose increase would inevitably increase the incidence of side effects, but it is likely that tailoring varenicline dosing to clients' needs would be safe and may further increase varenicline's efficacy.

This study will recruit 200 smokers who report little change to their enjoyment of cigarettes and no nausea, during the first week of varenicline use. These smokers will be randomised to receive the standard dose plus placebo or plus individualised varenicline dose up to 5mg, titrated over the next week prior to their target quit day. Urges to smoke, and other withdrawal symptoms, experienced during the study period will be compared between groups to see if the tailored therapy may be useful.

Being tested
Varenicline, Placebo
Keywords
Tobacco Dependence, Smoking cessation, Varenicline, Tailored dosing
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.

  • VareniclineDrug

    Also called Champix, Chantix

    Participants will increase varenicline dose by 0.5 mg twice daily every three days to a maximum of 2.5 mg twice daily. This increased dose will be continued for 3-weeks before being reduced to the standard dose of 1.0 mg twice daily.

  • PlaceboDrug

    Also called Champix, Chantix

    Participants will increase placebo dose by 0.5 mg twice daily every three days to a maximum of 2.5 mg twice daily. This increased dose will be continued for 3-weeks before being reduced to the standard varenicline dose of 1.0 mg twice daily.

  • VareniclineDrug

    Also called Champix, Chantix

    All participants will receive the standard dose of Varenicline (14 weeks): 0.5 mg once daily for days 1-3, 0.5 mg twice daily for days 4-7, and then a continuation dose of 1.0 mg twice daily. In addition to this participants will use an tailored varenicline/placebo dose up to maximum of 2.5 mg twice daily for 3 weeks.

Study groups in NCT01206010
Study groupRoleWhat they receive
Varenicline + Active Tailored DoseExperimentalNot described
Receives: Drug: Varenicline
Varenicline + Placebo Tailored DosePlacebo comparatorNot described
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 1-week after the target quit

    Rating of urges to smoke will be assessed using the Mood \& Physical Symptoms Scale

    Measured: 1 week

Secondary outcomes (6)

  1. Identification of the number of people with no effect of varenicline (as measured on a self reported questionnaire) prior to the target quit date

    Measured: 2 weeks pre quitting

  2. The change of withdrawal symptoms from target quit day over the first 4-weeks of abstinence assessed by the Mood and Physical Symptoms Scale

    Measured: 4 weeks post quitting

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

    Measured: 1-12 weeks post target quit date

  4. Profile of all adverse effects (as measured by a self reported questionnaire) reported up to 12-weeks post quitting

    Measured: Up to 12 weeks post quitting

  5. Client ratings (measured using a self-reporting questionnaire) of tailored treatment regimen

    Measured: Up to 12 weeks post quit

  6. Rating of urges to smoke 24 hours post target quit date

    Measured: 24 hours post target quit date

Timeline

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

  1. First posted21 Sep 2010 (estimated)
  2. Study startJul 2011
  3. Primary completionNov 2012
  4. Study completionFeb 2013

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
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01206010
Sponsor's protocol ID
qmul010610
Other IDs
2010-022335-11
Acronym
TVIN
Status last verified
Apr 2013
First submitted
14 Sep 2010
Last updated
25 Apr 2013
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, McRobbie H, Myers Smith K, Phillips A, Cornwall D, Dhanji AR. Increasing varenicline dose in smokers who do not respond to the standard dosage: a randomized clinical trial. JAMA Intern Med. 2015 Feb;175(2):266-71. doi: 10.1001/jamainternmed.2014.6916.

    PubMed 25545858

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Varenicline in people with Tobacco Dependence and Smoking Cessation, run by Queen Mary University of London at 1 site 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 4 inclusion and 7 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 25 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1-week after the target quit (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 NCT01206010, 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 25 Apr 2013.

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