UW-CTRI Triple Medication Smoking Cessation Study

• Status: Completed
• Trial end date: 2016-06-13
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Wisconsin, Madison
• Treatments: Nicotine; Varenicline

Criteria

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. -