Phase 4
Completed N=1,000
Changing the Default for Tobacco Treatment
Tobacco Use Cessation
Source: ClinicalTrials.gov NCT02721082 ↗
Enrolled (actual)
1,000
Serious AEs
28.0%
Results posted
Dec 2022
Primary outcomePrimary: 7-day Point-prevalence Abstinence — 21.5; 15.8 Percentage of participants quit at 1-mo
◆ Published Evidence
Established
33citations · ~11 / year
The Effects of Opt-out vs Opt-in Tobacco Treatment on Engagement, Cessation, and Costs: A Randomized Clinical Trial.
Summary
The purpose of this study is to determine the impact and efficacy of a new approach to smoking cessation treatment versus the traditional approach.
Linked Publications (3)
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The Effects of Opt-out vs Opt-in Tobacco Treatment on Engagement, Cessation, and Costs: A Randomized Clinical Trial.
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Changing the default for tobacco-cessation treatment in an inpatient setting: study protocol of a randomized controlled trial.
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Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7-day Point-prevalence Abstinence |
18.57; 17.90 | — |
| SECONDARY Treatment Engagement |
87.68; 37.84 | — |
| SECONDARY Default-theory Based Measures |
88.41; 86.64 | — |
| SECONDARY 7-day Point-prevalence Abstinence |
18.57; 17.90 | — |
Eligibility Criteria
Inclusion Criteria
- Speak English or Spanish
- Have access to a telephone or mobile phone
- Not be currently pregnant or breast feeding
- Have no significant co-morbidity that precludes participation
- Current daily smoker
- Not in treatment for tobacco dependence
- Reside in Kansas or Missouri
Exclusion Criteria
- Admission greater than 3 days
Data sourced from ClinicalTrials.gov (NCT02721082) and the linked publication. 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.