UW-CTRI Triple Medication Smoking Cessation Study

Completed · Phase 4

Conditions studied: Smoking

In brief

This study will focus on enhancing future smoking cessation treatment effectiveness by piloting a potentially more powerful combination of three FDA-approved pharmacotherapies: varenicline plus combination of two types of nicotine replacement therapy (NRT) treatment (nicotine lozenge and nicotine patch). Data from this pilot study will help inform the design of future studies that would use this combination treatment as a cessation tool within the chronic care arsenal of treatments.

Key facts

Study ID: NCT02681510
Run by: University of Wisconsin, Madison
People needed: 36
Starts: 2016-02-01
Expected to finish: 2016-06-13
Last updated by the study team: 2017-10-11

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Age >17 years;
>=5 cigarettes/day for the previous 6 months;
alveolar CO >= 6 ppm; able to read, write and speak English;
planning to remain in the intervention catchment area for at least 4 months; not currently taking bupropion or varenicline;
if the participant is currently using NRT, s/he agrees to use only study medication for the duration of the study;
free of medical contraindications to NRT and varenicline; and,
if participant is a woman of childbearing potential, using an approved method of birth control during treatment.

You may not qualify if…

Current diagnosis of/treatment for psychosis or bipolar disorder;
suicidal ideation within the past 12 months; any history of suicide attempts; * significant hepatic or renal impairment; history of significant allergic reactions to varenicline or any type of NRT in the past;
use of any investigational drugs in the previous 30 days. -

Where it is running

UW CTRI — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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