Phase 2
Completed N=188
Adaptive Pharmacotherapy for Smoking Cessation
Source: ClinicalTrials.gov NCT02501265 ↗Enrolled (actual)
188
Serious AEs
1.1%
Results posted
Aug 2021
Primary outcomePrimary: Biochemically-confirmed 30-day Continuous Smoking Abstinence — 5; 3; 18; 5 Participants
Summary
The purpose of this study is to assess an "adaptive" approach to smoking cessation pharmacotherapy. The protocol is designed to compare adaptive vs. standard approaches to two common smoking cessation pharmacotherapies - Varenicline (commonly known as Chantix) and the Nicotine Patch. The investigators hypothesize that participants allocated to adaptive therapy will show significantly higher biochemically confirmed 30-day continuous abstinence at 12 weeks post-Target Quit Day (TQD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biochemically-confirmed 30-day Continuous Smoking Abstinence |
5; 3; 18; 5 | — |
| SECONDARY 7-day Point Prevalence Biochemically Confirmed Abstinence |
6; 3; 23; 6 | — |
| SECONDARY Phone-assessed Self-reported Abstinence |
16; 5; 21; 6 | — |
| SECONDARY Change in Cigarettes Smoked Per Day |
80.4; 71.4; 89.4; 82.6 | — |
| SECONDARY Change in Cigarettes Smoked Per Day (Phone) |
67.6; 57.1; 84.8; 62.5 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- Actively smoking 5 or more cigarettes per day for at least one year
- Fluency in spoken and written English
- Willing to set a quit date within 6 weeks
- Access to a telephone
- Willingness to take Varenicline OR nicotine patch (patient choice)
- Willingness to take Bupropion
Exclusion Criteria
- Daily use of a second form of tobacco or nicotine (e.g. e-cigarettes, cigars, chewing tobacco, snuff).
- Current use of a smoking cessation medication (e.g. nicotine replacement, Varenicline, Bupropion).
- Report of pregnancy, attempting to get pregnant, or actively breast feeding or positive urine pregnancy test (only given to females with child bearing potential).
- Additional criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02501265). 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.