Treating Low-Income Smokers in the Hospital Emergency Department

NCT01328431 | Completed Results

• 2 other identifiers: 0907005437R01CA141479
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Use Cessation; Smoking Cessation; Smoking; Tobacco Use Disorder

Keywords

Tobacco Use Cessation; Smoking Cessation; Nicotine Replacement Therapy; Brief Intervention

Outcome Measures

Primary Outcomes (2)

• Biochemical Verification of Tobacco Abstinence

  Biochemical verification means a breathalyzer reading for carbon monoxide.

  3 months after enrollment

• Self-report of Tobacco Abstinence or Reduction

  Questionnaires to assess self reported tobacco abstinence

  3 months

Secondary Outcomes (5)

• Self-reported Tobacco Reduction or Abstinence

  1 month post enrollment

• Health Care Service Utilization

  1 month post enrollment

• Self-reported Tobacco Reduction or Abstinence

  12 months post enrollment

• Health Care Service Utilization

  3 months post enrollment

• Health Care Service Utilization

  12 months post enrollment

Study Arms (2)

Standard Care

NO INTERVENTION

Subjects receive a brochure for the state's Smokers' Quitline only.

SBIRT+NRT

EXPERIMENTAL

Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.

Other: Brief Intervention with NRT Initiation

Interventions

Brief Intervention with NRT Initiation OTHER

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.

SBIRT+NRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Tobacco Use Cessation; Smoking Cessation; Smoking; Tobacco Use Disorder

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Steven L. Bernstein, MD
• Organization: Yale University

steven.bernstein@yale.edu

203-737-3574

Study Officials

• Steven L. Bernstein, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 4, 2011
• Study Start: October 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: January 1, 2014
• Last Updated: August 4, 2014
• Results First Posted: August 4, 2014

Record last verified: 2014-07

Locations

US (1)