This trial is active, not recruiting.

Condition smoking
Treatment varenicline, nicotine patch and nicotine lozenge for 12 weeks
Phase phase 4
Sponsor University of Wisconsin, Madison
Start date February 2016
End date December 2016
Trial size 37 participants
Trial identifier NCT02681510, UW 2015-1376


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
varenicline, nicotine patch and nicotine lozenge for 12 weeks
varenicline, nicotine patch and nicotine lozenge for 12 weeks
Standard FDA approved 12 weeks of treatment with Varenicline, nicotine patch and nicotine lozenge.

Primary Outcomes

Safety and Tolerability of three drug combination medication assessed by adverse event rates
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - 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. -

Additional Information

Official title UW-CTRI Smoking Cessation Medication Tolerability Study
Principal investigator Michael C Fiore
Description Recent research suggests that a new combination therapy may be especially effective in increasing long-term abstinence from smoking. A key purpose of the proposed study is to examine what types of tolerability concerns, if any, emerge from the simultaneous use of three FDA-approved cessation medications (varenicline, nicotine patch, and nicotine lozenge) and the timing of those events, in order to better assess how the use of this combination of tobacco cessation medicines can be most effectively and safely delivered and monitored. Study participants will take the three medications for 12 weeks in a manner consistent with labeling. Adverse events will be assessed at all study visits.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.