UW-CTRI Triple Medication Smoking Cessation Study

Smoking Clinical Trial

Official title:

UW-CTRI Smoking Cessation Medication Tolerability Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681510
• Other study ID #: UW 2015-1376
• Status: Completed
• Phase: Phase 4
• First received: February 9, 2016
• Last updated: September 13, 2017
• Start date: February 2016
• Est. completion date: June 13, 2016

Study information

• Verified date: September 2017
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 13, 2016
• Est. primary completion date: June 13, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Smoking

Intervention

Drug:
• Varenicline
Standard FDA approved 12 weeks of treatment with Varenicline
• Nicotine Transdermal Patch
Standard FDA approved 12 weeks of treatment with Nicotine Transdermal Patch
• Nicotine Mini
Standard FDA approved 12 weeks of treatment with Nicotine Mini-Lozenge

Locations

Country	Name	City	State
United States	UW CTRI	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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