UW-CTRI Triple Medication Smoking Cessation Study

University of Wisconsin, Madison36 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Smoking

Interventions

VareniclineDRUG

Standard FDA approved 12 weeks of treatment with Varenicline

Nicotine Transdermal PatchDRUG

Standard FDA approved 12 weeks of treatment with Nicotine Transdermal Patch

Nicotine MiniDRUG

Standard FDA approved 12 weeks of treatment with Nicotine Mini-Lozenge

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. -

Locations (1)

UW CTRI

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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

Time frame: Week 12

Data from ClinicalTrials.gov

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