A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers

PHASE4CompletedINTERVENTIONAL
Enrollment

1,086

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

November 30, 2015

Study Completion Date

August 31, 2017

Conditions
Smoking CessationSmokingNicotine Dependence
Interventions
DRUG

Varenicline

Participants will receive 12 weeks of pharmacotherapy during the post-quit period plus an additional 7 day pre-quit run-in. Participants will be asked to take a 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (8 hours apart) for 4 days. On the 8th day, their target quit date, they will increase to their target maintenance dose of a 1 mg pill twice daily. If participants report significant adverse events such as nausea, a dose reduction to two 0.5 mg doses per day will be advised.

DRUG

Nicotine lozenge

Participants will receive 12 weeks NRT. Participants will be given 2 mg or 4 mg lozenges based on morning smoking latency, and will be given package insert use instructions. Medication use will start on the morning of their assigned quit day. They will be urged to use at least 5 pieces/day, unless this amount produces adverse effects.

DRUG

Nicotine Patch

Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.

Trial Locations (2)

53233

University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health, Milwaukee

53711

University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health, Madison

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

University of Wisconsin, Madison

OTHER

NCT01553084 - A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers | Biotech Hunter | Biotech Hunter