UW-CTRI Triple Medication Smoking Cessation Study

NCT ID: NCT02681510

Last Updated: 2017-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-06-13

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.

Conditions

Smoking

Keywords

medication tolerability

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Three drug intervention

varenicline, nicotine patch and nicotine lozenge for 12 weeks

Group Type: EXPERIMENTAL

Varenicline

Intervention Type: DRUG

Standard FDA approved 12 weeks of treatment with Varenicline

Nicotine Transdermal Patch

Intervention Type: DRUG

Standard FDA approved 12 weeks of treatment with Nicotine Transdermal Patch

Nicotine Mini

Intervention Type: DRUG

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

Interventions

Varenicline

Standard FDA approved 12 weeks of treatment with Varenicline

Intervention Type: DRUG

Nicotine Transdermal Patch

Standard FDA approved 12 weeks of treatment with Nicotine Transdermal Patch

Intervention Type: DRUG

Nicotine Mini

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

Intervention Type: DRUG

Other Intervention Names

Chantix; Nicotine Mini-Lozenge

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. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael C Fiore

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin--CTRI

Locations

UW CTRI

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30524509 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UW 2015-1376

Identifier Type: -

Identifier Source: org_study_id