UW-CTRI Triple Medication Smoking Cessation Study

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ClinicalTrials.gov Identifier: NCT02681510

Recruitment Status : Completed

First Posted : February 12, 2016

Results First Posted : October 11, 2017

Last Update Posted : October 11, 2017

Sponsor:

Information provided by (Responsible Party):

University of Wisconsin, Madison

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Smoking	Drug: Varenicline Drug: Nicotine Transdermal Patch Drug: Nicotine Mini	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	36 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	UW-CTRI Smoking Cessation Medication Tolerability Study
Actual Study Start Date :	February 2016
Actual Primary Completion Date :	June 13, 2016
Actual Study Completion Date :	June 13, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines Quitting Smoking Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex Varenicline Varenicline tartrate

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: Nicotine Mini-Lozenge

Outcome Measures

Primary Outcome Measures :

Number of Participants With Adverse Events [ Time Frame: 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 :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 99 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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. -

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02681510

Locations

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

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

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Principal Investigator:	Michael C Fiore	University of Wisconsin--CTRI

Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:

Informed Consent Form [PDF] January 19, 2016

Study Protocol and Statistical Analysis Plan [PDF] January 19, 2016

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT02681510
Other Study ID Numbers:	UW 2015-1376
First Posted:	February 12, 2016 Key Record Dates
Results First Posted:	October 11, 2017
Last Update Posted:	October 11, 2017
Last Verified:	September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by University of Wisconsin, Madison:


medication tolerability

Additional relevant MeSH terms:

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Nicotine Varenicline Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs	Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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