UW-CTRI Triple Medication Smoking Cessation Study

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University of Wisconsin (UW)

Status and phase

Completed
Phase 4

Conditions

Smoking

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02681510
UW 2015-1376

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

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. -

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

36 participants in 1 patient group

Three drug intervention
Experimental group
Description:
varenicline, nicotine patch and nicotine lozenge for 12 weeks
Treatment:
Drug: Nicotine Mini
Drug: Nicotine Transdermal Patch
Drug: Varenicline

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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