Tailoring Varenicline to Individual Needs (TVIN Study) (TVIN)

April 24, 2013 updated by: Dr. Al-Rehan Abdul Aziz Dhanji, Queen Mary University of London

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, E1 2JH
        • Tobacco Dependence Research and Treatment Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Varenicline + Active Tailored Dose
Drug: Varenicline
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.
Other Names:
  • Champix
  • Chantix
Drug: Varenicline
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.
Other Names:
  • Champix
  • Chantix
Placebo Comparator: Varenicline + Placebo Tailored Dose
Drug: Varenicline
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.
Other Names:
  • Champix
  • Chantix
Drug: Varenicline
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.
Other Names:
  • Champix
  • Chantix
Drug: Placebo
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.
Other Names:
  • Champix
  • Chantix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rating of urges to smoke 1-week after the target quit
Time Frame: 1 week
Rating of urges to smoke will be assessed using the Mood & Physical Symptoms Scale
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Identification of the number of people with no effect of varenicline (as measured on a self reported questionnaire) prior to the target quit date
Time Frame: 2 weeks pre quitting
2 weeks pre quitting
The change of withdrawal symptoms from target quit day over the first 4-weeks of abstinence assessed by the Mood and Physical Symptoms Scale
Time Frame: 4 weeks post quitting
4 weeks post quitting
Validated abstinence rates at 1-12 weeks post target quit date
Time Frame: 1-12 weeks post target quit date
1-12 weeks post target quit date
Profile of all adverse effects (as measured by a self reported questionnaire) reported up to 12-weeks post quitting
Time Frame: Up to 12 weeks post quitting
Up to 12 weeks post quitting
Client ratings (measured using a self-reporting questionnaire) of tailored treatment regimen
Time Frame: Up to 12 weeks post quit
Up to 12 weeks post quit
Rating of urges to smoke 24 hours post target quit date
Time Frame: 24 hours post target quit date
24 hours post target quit date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Investigators

  • Principal Investigator: Al-Rehan Abdul Aziz Dhanji, MB.BS., BSc.,MRCS., Queen Mary University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

September 20, 2010

First Posted (Estimate)

September 21, 2010

Study Record Updates

Last Update Posted (Estimate)

April 25, 2013

Last Update Submitted That Met QC Criteria

April 24, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • qmul010610
  • 2010-022335-11 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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