MedTrace Logo

Optimizing Tobacco Dependence Treatment in the Emergency Department

NCT02896400 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1056

Last updated 2020-12-04

Study results available
· View outcomes & findings →

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.

Conditions

  • Tobacco Use Disorder

Interventions

BEHAVIORAL

Brief Negotiated Interview (BNI)

Brief motivational interview on smoking behavior

DRUG

Nicotine replacement therapy (NRT)

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.

OTHER

CT Smokers Quitline (QL)

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

OTHER

SmokefreeText (Text)

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Steven L Bernstein, MD · Yale School of Medicine, Department of Emergency Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-13
Primary Completion
2019-08-14
Completion
2019-08-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02896400 on ClinicalTrials.gov