Tailoring Varenicline to Individual Needs (TVIN Study)

NCT01206010 | Completed Phase 3

• 2 other identifiers: qmul0106102010-022335-11
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Tobacco Dependence; Smoking Cessation

Keywords

Tobacco Dependence; Smoking cessation; Varenicline; Tailored dosing

Outcome Measures

Primary Outcomes (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

  1 week

Secondary Outcomes (6)

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

  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

  4 weeks post quitting

• Validated abstinence rates at 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

  Up to 12 weeks post quitting

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

  Up to 12 weeks post quit

Study Arms (2)

Varenicline + Active Tailored Dose

EXPERIMENTAL

Drug: Varenicline

Varenicline + Placebo Tailored Dose

PLACEBO COMPARATOR

Drug: Placebo; Drug: Varenicline

Interventions

Varenicline DRUG

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.

Also known as: Champix, Chantix

Varenicline + Active Tailored Dose

Placebo DRUG

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.

Also known as: Champix, Chantix

Varenicline + Placebo Tailored Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Tobacco Dependence Research and Treatment 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: 37142273 DERIVED

• 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.

  PMID: 25545858 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Al-Rehan Abdul Aziz 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: Clinical Fellow in Cardiothoracic Surgery

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 21, 2010
• Study Start: July 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: February 1, 2013
• Last Updated: April 25, 2013

Record last verified: 2013-04

Locations

GB (1)