drugset / Trial / NCT02896400

Optimizing Tobacco Dependence Treatment in the Emergency Department

NCT02896400 ↗

RandomizedFactorialSingle-blindTreatment

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.

Timeline

Start
2017-02-13
Primary completion
2019-08-14
Completion
2019-08-14

Outcome

Mixed primary results

registry analysis (superiority test); Brief Negotiated Interview (BNI) vs Brief Negotiated Interview (BNI) CONTROL; p = .01; Odds Ratio (OR) 1.8 (95% CI 1.1 to 2.8); NCT02896400 ↗

registry analysis (superiority test); Nicotine Replacement Therapy (NRT) vs Nicotine Replacement Therapy (NRT) CONTROL; p = .001; Odds Ratio (OR) 2.1 (95% CI 1.3 to 3.2); NCT02896400 ↗

registry analysis (superiority test); Quitline (QL) vs Quitline (QL) CONTROL; p = 0.14; Odds Ratio (OR) 1.4 (95% CI 0.9 to 2.2); NCT02896400 ↗

registry analysis (superiority test); Text vs Text CONTROL; p = 0.64; Odds Ratio (OR) 1.1 (95% CI 0.7 to 1.7); NCT02896400 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Nicotine Unknown 2 mg —
Subject Nicotine Unknown 14 mg —
Subject Nicotine Unknown 21 mg —

Indications