Phase 4
Completed N=36
UW-CTRI Triple Medication Smoking Cessation Study
Source: ClinicalTrials.gov NCT02681510 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Number of Participants With Adverse Events — 27; 26; 23; 15 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
27; 26; 23; 15; 14; 7 | — |
| SECONDARY Participant Satisfaction With Medications' Ability to Control Withdrawal Symptoms |
9.1 | — |
| SECONDARY Participant Satisfaction With Medications' Ability to Help Participant Quit Smoking |
9.2 | — |
| SECONDARY Number of Participants Who Reported Quitting at the End of Treatment |
21 | — |
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. -
Data sourced from ClinicalTrials.gov (NCT02681510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.