UW-CTRI Triple Medication Smoking Cessation Study

UW-CTRI Smoking Cessation Medication Tolerability Study

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Drug: Varenicline; Drug: Nicotine Transdermal Patch; Drug: Nicotine Mini

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53711
      • UW CTRI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Michael C Fiore, University of Wisconsin--CTRI

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): June 13, 2016
• Study Completion (Actual): June 13, 2016

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimate): February 12, 2016

Study Record Updates

• Last Update Posted (Actual): October 11, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: medication tolerability
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine; Varenicline
• Other Study ID Numbers: UW 2015-1376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED