UW-CTRI Triple Medication Smoking Cessation Study

NCT02681510 | Completed Phase 4 Results DMC

• 1 other identifier: UW 2015-1376
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Keywords

medication tolerability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Participant Satisfaction With Medications' Ability to Control Withdrawal Symptoms

  Week 12

• Participant Satisfaction With Medications' Ability to Help Participant Quit Smoking

  Week 12

• Number of Participants Who Reported Quitting at the End of Treatment

  Week 12

Study Arms (1)

Three drug intervention

EXPERIMENTAL

varenicline, nicotine patch and nicotine lozenge for 12 weeks

Drug: Varenicline; Drug: Nicotine Transdermal Patch; Drug: Nicotine Mini

Interventions

Varenicline DRUG

Standard FDA approved 12 weeks of treatment with Varenicline

Also known as: Chantix

Three drug intervention

Nicotine Transdermal Patch DRUG

Standard FDA approved 12 weeks of treatment with Nicotine Transdermal Patch

Three drug intervention

Nicotine Mini DRUG

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

Also known as: Nicotine Mini-Lozenge

Three drug intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UW CTRI

Madison, Wisconsin, 53711, United States

Location

Related Publications (1)

• 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.

  PMID: 30524509 DERIVED

MeSH Terms

Conditions

Smoking

Interventions

Varenicline; Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Therapeutics

Results Point of Contact

• Title: Stevens S. Smith, Ph.D.
• Organization: Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health

sss@ctri.wisc.edu

6082627563

Study Officials

• Michael C Fiore

  University of Wisconsin--CTRI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 12, 2016
• Study Start: February 1, 2016
• Primary Completion: June 13, 2016
• Study Completion: June 13, 2016
• Last Updated: October 11, 2017
• Results First Posted: October 11, 2017

Record last verified: 2017-09

Locations

US (1)