Phase 3
N=1,056
Optimizing Tobacco Dependence Treatment in the Emergency Department
Tobacco Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02896400 ↗Enrolled (actual)
1,056
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Tobacco Abstinence — 71; 49; 76; 44 Participants — p=.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brief Negotiated Interview (BNI) (Behavioral); Nicotine replacement therapy (NRT) (Drug); CT Smokers Quitline (QL) (Other); SmokefreeText (Text) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tobacco Abstinence |
71; 49; 76; 44; 66; 54 | .01 sig |
Summary
The investigators propose an innovative full-factorial design in a cohort of 1056 adult smokers in an urban emergency department (ED), to test the efficacy of four key intervention components: motivational interviewing, medication, quitline referral, and texting. At the trial's completion, a mixed-methods approach will be used to identify the components that were efficacious within the proposed cost constraint, along with feasibility and acceptability to providers and subjects. The investigators will then assemble an intervention that maximizes efficacy, given a cost-effectiveness constraint and findings from a qualitative analysis.
Eligibility Criteria
Inclusion Criteria
- 18 years or older
- have smoked >= 100 cigarettes lifetime
- describe themselves as every or some day smokers
- smoke at least 5 cigarettes/day
- own a cellphone with texting capability
- are able to give written informed consent
Exclusion Criteria
- Inability to read or understand English
- currently receiving formal tobacco dependence treatment
- life-threatening or unstable medical, surgical, or psychobehavioral condition
- unable to provide at least one collateral contact
- live out-of-state
- leaving the ED against medical advice
- pregnant (self-report or urine testing), nursing, or trying to conceive.
Data sourced from ClinicalTrials.gov (NCT02896400). 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.