Tailoring Varenicline to Individual Needs (TVIN Study)

PHASE3CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

November 30, 2012

Study Completion Date

February 28, 2013

Conditions
Tobacco DependenceSmoking Cessation
Interventions
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.

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.

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.

Trial Locations (1)

E1 2JH

Tobacco Dependence Research and Treatment Unit, London

All Listed Sponsors
lead

Queen Mary University of London

OTHER

NCT01206010 - Tailoring Varenicline to Individual Needs (TVIN Study) | Biotech Hunter | Biotech Hunter