Tailoring Varenicline to Individual Needs (TVIN Study)

Smoking Cessation Clinical Trial

— TVIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206010
• Other study ID #: qmul010610
• Secondary ID: 2010-022335-11
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2010
• Last updated: April 24, 2013
• Start date: July 2011
• Est. completion date: February 2013

Study information

• Verified date: April 2013
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency (approved Jan 2011, 22310/0006/001-0001)United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Tobacco Dependence Research and Treatment Unit	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Validated abstinence rates at 1-12 weeks post target quit date		1-12 weeks post target quit date	No
Secondary	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	Yes
Secondary	Client ratings (measured using a self-reporting questionnaire) of tailored treatment regimen		Up to 12 weeks post quit	No
Secondary	Rating of urges to smoke 24 hours post target quit date		24 hours post target quit date	No