CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 780 enrolled
Drug / intervention
Brief Intervention with NRT Initiationother
Likely dose
Not stated in 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/NCT01328431
NCT01328431N/ACompleted

Treating Low-Income Smokers in the Hospital Emergency Department

Yale University·interventional·Posted Apr 4, 2011·Updated Aug 4, 2014

In Brief

A clinical study evaluating Brief Intervention with NRT Initiation for Tobacco Use Cessation and 3 related conditions. Completed, enrolled 780 participants across 1 site.

Detailed Summary

This study will test the effectiveness of an Emergency Department (ED) initiated tobacco intervention which includes counseling and medication. Our proposed intervention combines a Brief Negotiated Interview (BNI) with initiation of nicotine patch and gum in the ED, as well as a faxed referral to the state's Smokers' Quitline. A 6 week supply of nicotine patches and nicotine gum are provided to subjects in the intervention arm. Subjects randomized to the control arm will receive a brochure from the state's Smokers' Quitline only. The primary hypothesis is that the intervention will be superior to the control condition in reducing self-reported and biochemically verified 7-day tobacco abstinence at 3 months.

Study Details

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

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 4, 2011
Enrollment StartOct 1, 2010
Primary CompletionApr 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 15.2 years ago

Interventions

Brief Intervention with NRT Initiationother

Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor.