AzTrials
AzTrials

Tobacco Use CessationNCT01328431

Treating Low-Income Smokers in the Hospital Emergency Department

A study testing Brief Intervention with NRT Initiation in people with Tobacco Use Cessation and Smoking Cessation, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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'… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tobacco Use Cessation, Smoking Cessation, Smoking
What is being tested?
Brief Intervention with NRT Initiation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
780 participants
Where
1 siteUnited States
Study dates
Oct 2010to Jan 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Yale University

    New Haven, Connecticut, 06510

Other trials in United States

About this study

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.

Read the detailed description

Of the nation's 45 million adult smokers, nearly 20 million visit hospital emergency departments (EDs) each year. ED patients, particularly smokers, are disproportionately low-income, with limited access to traditional primary care settings. Patients presenting to the ED with a tobacco-related trigger event, like an asthma attack, may be experiencing a "teachable moment." Thus, the ED may be an ideal location in which to identify smokers and initiate treatment for tobacco dependence. Initial pilot research by our group has demonstrated the feasibility of ED-based brief interventions for smokers. Based on our feasibility studies, the Institute of Medicine 2006 report on tobacco and the 2008 US Public Health Service guidelines now list EDs as appropriate loci for tobacco control efforts. This study aims to test the efficacy of an ED-initiated tobacco intervention which includes counseling and medication. The intervention-Screening, Brief Intervention, and Referral to Treatment (SBIRT)-uses a form of motivational interviewing known as the Brief Negotiation Interview (BNI). Our proposed intervention combines a BNI with initiation of nicotine replacement therapy (NRT) and a fax referral to the state Smokers' Quitline during the ED visit. A 6-week starter kit of NRT (patch and/or gum, tailored to level of addiction and patient preference) will be provided with written materials. The initial dose of NRT will be given in the ED. A trained nurse will administer the booster intervention via telephone 3 days post-visit. The SBIRT+NRT arm will be compared to standard care (SC), which consists of written materials only, in a controlled trial of 778 smokers age 18 years or older randomized in a 1:1 fashion.

The primary hypothesis is that SBIRT+NRT will be superior to SC in reducing self-reported and biochemically verified 7-day tobacco abstinence at 3 months. Secondary hypotheses include: (1) Patients with a tobacco related diagnosis for the ED visit will have a higher cessation rate than patients without a tobacco related diagnosis, and (2) Patients who believe their ED visit is smoking-related will have a higher quit rate than others. The investigators will conduct a cost benefit analysis of the interventions. Follow-up assessments at 1, 3 and 12 months will combine self-report with in-person carbon monoxide testing at 3 months for smokers who assert abstinence via phone. Expansions of the proposed project as compared to earlier studies include: 1) initiation of NRT during the ED visit; 2) provision of multiple forms of NRT; 3) a proactive referral made to the Quitline; 4)a credible control condition with minimal baseline assessment, to avoid the assessment reactivity seen in similar ED studies; and 5) an economic analysis of the tested interventions.

Being tested
Brief Intervention with NRT Initiation
Keywords
Tobacco Use Cessation, Smoking Cessation, Nicotine Replacement Therapy, Brief Intervention
Medical subject headings
Tobacco Use Cessation, Smoking Cessation, Smoking, Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT01328431
Study groupRoleWhat they receive
Standard CareNo interventionSubjects receive a brochure for the state's Smokers' Quitline only.
SBIRT+NRTExperimentalSubjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.
Receives: Other: Brief Intervention with NRT Initiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemical Verification of Tobacco Abstinence

    Biochemical verification means a breathalyzer reading for carbon monoxide.

    Measured: 3 months after enrollment

  2. Self-report of Tobacco Abstinence or Reduction

    Questionnaires to assess self reported tobacco abstinence

    Measured: 3 months

Secondary outcomes (5)
  1. Self-reported Tobacco Reduction or Abstinence

    self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.

    Measured: 1 month post enrollment

  2. Health Care Service Utilization

    A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.

    Measured: 1 month post enrollment

  3. Self-reported Tobacco Reduction or Abstinence

    self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.

    Measured: 12 months post enrollment

  4. Health Care Service Utilization

    A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.

    Measured: 3 months post enrollment

  5. Health Care Service Utilization

    A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.

    Measured: 12 months post enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2011 (estimated)
  2. Study startOct 2010
  3. Primary completionApr 2013
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
780 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01328431
Sponsor's protocol ID
0907005437
Other IDs
R01CA141479
Status last verified
Jul 2014
First submitted
30 Mar 2011
Last updated
4 Aug 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Brief Intervention with NRT Initiation in people with Tobacco Use Cessation and Smoking Cessation, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemical Verification of Tobacco Abstinence (time frame: 3 months after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2014.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in