Clinical trial NCT02681510: UW-CTRI Triple Medication Smoking Cessation Study
Official title: UW-CTRI Smoking Cessation Medication Tolerability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking
Keywords: medication tolerability
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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. -

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 12 weeks
Secondary outcomes:
measure: Participant Satisfaction With Medications' Ability to Control Withdrawal Symptoms
timeFrame: Week 12
measure: Participant Satisfaction With Medications' Ability to Help Participant Quit Smoking
timeFrame: Week 12
measure: Number of Participants Who Reported Quitting at the End of Treatment
timeFrame: Week 12
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW CTRI
state: Wisconsin
Study officials:
affiliation: University of Wisconsin--CTRI
name: Michael C Fiore
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berg KM, Jorenby DE, Baker TB, Fiore MC. Triple Smoking Cessation Therapy with Varenicline, Nicotine Patch and Nicotine Lozenge: A Pilot Study to Assess Tolerability, Satisfaction, and End-of-Treatment Quit Rates. J Smok Cessat. 2018 Sep;13(3):145-153. doi: 10.1017/jsc.2017.18. Epub 2017 Sep 25.