UW-CTRI Triple Medication Smoking Cessation Study

Phase 4

Completed

Interventions: Drug: Varenicline
Drug: Nicotine Transdermal Patch
Drug: Nicotine Mini

Brief 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.

Detailed 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.

Recruitment & Eligibility

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. -

Arm && Interventions

Group	Intervention	Description
Three drug intervention	Nicotine Transdermal Patch	varenicline, nicotine patch and nicotine lozenge for 12 weeks
Three drug intervention	Nicotine Mini	varenicline, nicotine patch and nicotine lozenge for 12 weeks
Three drug intervention	Varenicline	varenicline, nicotine patch and nicotine lozenge for 12 weeks

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	12 weeks	Assess adverse event rates in relation to participant ability to continue use of all 3 medications throughout the treatment period

Secondary Outcome Measures

Name	Time	Method
Participant Satisfaction With Medications' Ability to Control Withdrawal Symptoms	Week 12	Satisfaction with Medications' Ability to Control Withdrawal Symptoms assessed on a 1-10 Likert Scale (higher value=greater satisfaction)
Number of Participants Who Reported Quitting at the End of Treatment	Week 12	Self-reported Quit Rate at End of Treatment (12 Weeks); assessed as no smoking in the 7 days prior to the Week 12 follow-up call
Participant Satisfaction With Medications' Ability to Help Participant Quit Smoking	Week 12	Participant Satisfaction with Medications' Ability to Help Participant Quit Smoking assessed on a 1-10 Likert Scale (higher value=greater satisfaction)