Phase 4
Completed N=623
A Comparative Effectiveness RCT of Optimized Cessation Treatments
Source: ClinicalTrials.gov NCT02301403 ↗Enrolled (actual)
623
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Number of Participants With Abstinence From Smoking — 19; 49 Participants — p=<.001
Summary
This study is a 2-arm randomized clinical trial (RCT). Participants motivated to quit smoking will be randomized to one of two treatments: 1) a Modern Usual Care (M-UC) vs. 2) Abstinence-Optimized Cessation Treatment (AOCT). The components for the optimized treatment have strong theoretical and empirical support from the investigators previous screening studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Abstinence From Smoking |
19; 49 | <.001 sig |
Eligibility Criteria
Inclusion Criteria
- age >=18 years
- smoking >4 cigarettes/day for the previous 6 months
- able to read, write, and speak English
- have reliable phone access and agree to respond to Interactive Voice Response (IVR) phone prompts
- and if currently using NRT, agreeing to use only study medication for the duration of the study
- we will not exclude participants based on their prior use of cessation medication or if they use multiple tobacco products in order to enhance real-world generalization (these will be statistically controlled in analyses)
- not currently attempting to quit smoking
- not intending to quit smoking (defined as no plans to quit in the next month)
- and planning to remain in the intervention catchment area for at least 12 months.
Exclusion Criteria
- currently taking bupropion or varenicline
- medical contraindications to using NRT including hospitalized (for at least one night) for a stroke, heart attack, congestive heart failure or diabetes in the last 30 days
- diagnosis of or treatment for schizophrenia, a psychotic disorder or bipolar disorder in the last 10 years
- and, if the participant is a woman of childbearing potential, being pregnant or intending to becoming pregnant or unwillingness to use an approved method of birth control during treatment.
Data sourced from ClinicalTrials.gov (NCT02301403). 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.