UW-CTRI Triple Medication Smoking Cessation Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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UW-CTRI Smoking Cessation Medication Tolerability Study

Conditions
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Smoking

Intervention / Treatment
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* Drug: Varenicline
* Drug: Nicotine Transdermal Patch
* Drug: Nicotine Mini


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Three drug intervention<br>varenicline, nicotine patch and nicotine lozenge for 12 weeks | Drug: Varenicline<br>* Standard FDA approved 12 weeks of treatment with Varenicline<br>* Other names: Chantix;Drug: Nicotine Transdermal Patch<br>* Standard FDA approved 12 weeks of treatment with Nicotine Transdermal Patch<br>Drug: Nicotine Mini<br>* Standard FDA approved 12 weeks of treatment with Nicotine Mini-Lozenge<br>* Other names: Nicotine Mini-Lozenge;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | Assess adverse event rates in relation to participant ability to continue use of all 3 medications throughout the treatment period | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Satisfaction With Medications' Ability to Control Withdrawal Symptoms | Satisfaction with Medications' Ability to Control Withdrawal Symptoms assessed on a 1-10 Likert Scale (higher value=greater satisfaction) | Week 12 | 
| Participant Satisfaction With Medications' Ability to Help Participant Quit Smoking | Participant Satisfaction with Medications' Ability to Help Participant Quit Smoking assessed on a 1-10 Likert Scale (higher value=greater satisfaction) | Week 12 | 
| Number of Participants Who Reported Quitting at the End of Treatment | 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 | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medication tolerability