N/A Completed N=780 Randomized Triple-blind Treatment

Treating Low-Income Smokers in the Hospital Emergency Department

Tobacco Use Cessation · Smoking Cessation · Smoking · Tobacco Use

Source: ClinicalTrials.gov NCT01328431 ↗

Enrolled (actual)

780

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcomePrimary: Biochemical Verification of Tobacco Abstinence — 19; 47 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Biochemical Verification of Tobacco Abstinence	19; 47	—
PRIMARY Self-report of Tobacco Abstinence or Reduction	34; 63	—
SECONDARY Self-reported Tobacco Reduction or Abstinence	—	—
SECONDARY Health Care Service Utilization	—	—

Eligibility Criteria

Inclusion Criteria

Age > 18 years
Speaks English
Willing and able to give informed consent
>100 cigarettes lifetime
Current daily or some day smoker
Smokes > 5 cigarettes/day
Medicaid or self-pay insurance

Exclusion Criteria

Too ill or unable to consent
Not interested in study participation
Not interested in quitting
Pregnant, nursing, or trying to conceive
Current use of tobacco cessation products (patch, gum, inhaler, nasal spray, lozenge, e-cigarette)
Actively psychotic or mentally ill
Leaving ED against medical advice
Investigator discretion
Lives outside of New Haven County
Does not have phone with CT area code
In police custody
History of allergic reaction to nicotine replacement products
Currently receiving formal tobacco dependence tx
Currently taking Zyban, Wellbutrin (bupropion) or Chantix(varenicline)
Resides in an extended care facility

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01328431). 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. Informational only — not medical advice.