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Tobacco UseNCT00297466

Strategies to Help Adult ED Patients Quit Smoking

A study testing transdermal nicotine patches and Motivational interview in people with Tobacco Use, run by National Institute on Drug Abuse (NIDA) 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
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Trial summary

The purpose of this study is to determine whether a brief, focused intervention in the hospital emergency department is effective in helping adults quit smoking. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Tobacco Use
What is being tested?
transdermal nicotine patches and Motivational interview
How many people
336 participants
Where
1 siteUnited States
Study dates
Jan 2006to May 2008
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • >= 10 cigarettes smoked daily
  • being discharged from the ED
  • contemplation or preparation stage of change
  • speaks English or Spanish

Who cannot join

  • being admitted to hospital
  • too ill to consent

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

About this study

The purpose of this study is to determine whether a brief, focused intervention in the hospital emergency department is effective in helping adults quit smoking.

Read the detailed description

In urban communities, the prevalence of tobacco use among adults visiting a hospital emergency department (ED) nears 40%, well in excess of the 25% smoking prevalence rate of the general population. Many of these patients lack easy access to primary care, suggesting the ED may be an attractive locus to initiate tobacco cessation efforts. With over 100 million annual visits to U.S. EDs, it may be possible to engage millions of smokers in tobacco cessation efforts. The major purpose of this study is to examine whether a multicomponent intervention delivered in the ED by a Lay Educator to adult smokers interested in quitting is more likely to result in cessation than usual care. A secondary goal is to test whether patients who present to the ED with a tobacco-related illness (as indicated by ICD9 code) are more likely to quit than ED smokers with a non-tobacco-related condition. This will allow us to test the validity of the "teachable moment" as an opportune time to engage patients in considering a behavioral change. The proposed study is a randomized trial of a motivational interview, provision of six weeks' worth of nicotine patches, literature, and post-visit follow-up (Enhanced Care) vs. referral to a cessation clinic (Minimal Care) for ED patients who smoke. Eligibility criteria: age > 21 years, contemplation or preparation stage of change, not admitted to hospital. All patients will undergo a standardized stage of change assessment, and measurements of nicotine dependence and exhaled carbon monoxide. All will receive a cessation fact sheet and referral card to the smoking cessation clinic; the cards of those in the Enhanced Care group will have a specific appointment date and time. The Enhanced Care group will receive a language-appropriate pamphlet discussing smoking cessation. We will record the ICD9 codes associated with each visit. Major outcome measure: cessation within 3 months of the ED visit, stratified by treatment group. Secondary outcome measure: cessation within 3 months of the ED visit, stratified by whether the visit was smoking-related. If smokers receiving Enhanced Care are more likely to quit, then the ED could be considered a new, effective locus for tobacco control, potentially reaching several million smokers. If patients with a smoking-related diagnosis for the ED visit are more likely to quit than those with non-smoking-related ICD9, then this supports the construct of the teachable moment.

Conditions
Tobacco Use
Being tested
transdermal nicotine patches, Motivational interview
Keywords
tobacco use, smoking cessation, emergency department
Medical subject headings
Tobacco Use, Smoking Cessation, Emergencies

What participants receive

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

  • transdermal nicotine patchesDrug

  • Motivational interviewBehavioural

What is being measured

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

  1. 3-month cessation rate

Secondary outcomes (3)
  1. 3-month quit attempts,

  2. daily cigarette consumption,

  3. stage of change assessment

Timeline

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

  1. First posted28 Feb 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionApr 2007
  4. Study completionMay 2008

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
None (open label)
Enrolment
336 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00297466
Sponsor's protocol ID
DA017812
Status last verified
Feb 2006
First submitted
24 Feb 2006
Last updated
11 Jan 2017
Results posted
No

Publications

  • Bernstein SL, Cooperman N, Jearld S, Moadel A, Bijur P, Gallagher EJ. Predictors of in-person follow-up among subjects in an ED-based smoking cessation trial. Am J Emerg Med. 2012 Nov;30(9):2067-9. doi: 10.1016/j.ajem.2012.06.011. Epub 2012 Sep 20. No abstract available.

    PubMed 23000321
  • Bernstein SL, Bijur P, Cooperman N, Jearld S, Arnsten JH, Moadel A, Gallagher EJ. A randomized trial of a multicomponent cessation strategy for emergency department smokers. Acad Emerg Med. 2011 Jun;18(6):575-83. doi: 10.1111/j.1553-2712.2011.01097.x.

    PubMed 21676054

Questions about this trial

What is this clinical trial studying?

A study testing transdermal nicotine patches and Motivational interview in people with Tobacco Use, run by National Institute on Drug Abuse (NIDA) 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 4 inclusion and 2 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 11 Jan 2017. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

3-month cessation rate. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00297466, which also lists 2 linked publications.

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 11 Jan 2017.

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