CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,056 enrolled
Drug / intervention
Nicotine replacement therapy (NRT) +3 moredrug
Likely dose
Nicotine replacement therapy (NRT) 14mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02896400
NCT02896400Phase 3Completed

Optimizing Tobacco Dependence Treatment in the Emergency Department

Yale University·interventional·Posted Sep 12, 2016·Updated Dec 4, 2020

In Brief

A Phase 3 clinical trial evaluating Brief Negotiated Interview (BNI), Nicotine replacement therapy (NRT), and 2 other interventions for Tobacco Use Disorder. Completed, enrolled 1,056 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 12, 2016
Enrollment StartFeb 13, 2017
Primary CompletionAug 14, 2019
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.8 years ago

Interventions

Brief Negotiated Interview (BNI)behavioral

Brief motivational interview on smoking behavior

Nicotine replacement therapy (NRT)drug

6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.

CT Smokers Quitline (QL)other

Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.

SmokefreeText (Text)other

Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.