AzTrials
AzTrials

Tobacco UsePhase 1/2NCT00252902

Emergency Department Initiated Tobacco Treatment (EDITT)

A Phase 1/2 study testing Behavior change counseling 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
Search all trials

Trial summary

The primary purpose of the study is to refine the intervention protocols for two ED-initiated tobacco interventions and to assess the magnitude of the effect size that can be expected. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tobacco Use
What is being tested?
Behavior change counseling
How many people
75 participants
Where
1 siteUnited States
Study dates
Dec 2005to Dec 2007
Phase
Phase 1/2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years old
  • receiving treatment in the ED
  • smoking at least 10 cigarettes daily

Who cannot join

  • too ill to participate
  • temporary shelter
  • no phone

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cooper University Hospital

    Camden, New Jersey, 08103

Other trials in United States

About this study

The primary purpose of the study is to refine the intervention protocols for two ED-initiated tobacco interventions and to assess the magnitude of the effect size that can be expected. We expect the intervention groups to have greater sustained abstinence, point-prevalence abstinence, and motivation to change when compared to the treatment as usual group at 1- and 3-month follow-up.

Read the detailed description

Most surveys of emergency physicians indicate that smoking cessation counseling rarely occurs in routine clinical practice. Prochazka and colleagues (1996) studied 196 members of the Colorado Chapter of the American College of Emergency Physicians and found that only 27% reported routinely asking patients to quit smoking. We conducted a similar survey study and found that only 19% of emergency physicians practicing in an urban teaching hospital reported that they routinely counseled their tobacco using patients to quit. A study of 63 adult smokers presenting to the ED with symptoms of acute respiratory illness found that only 9% were offered any assistance with quitting (Bock et al., 2001). Clearly, more research was needed to investigate smoking interventions initiated in the ED.

Currently, not much is known about how best to intervene with smokers in the ED. This proposal describes a pilot study designed to explore two interventions. Research that expands our knowledge of ED-initiated tobacco interventions has tremendous public health potential, especially for the under-served populations that are over-represented in the ED patient population.This study is designed primarily to yield effects size parameters so a larger RCT can be planned. For this reason, it is not powered specifically to detect a given difference, but, rather, simply to provide an idea of the size of the effect so we can determine how many subjects would be needed in a future trial in order to demonstrate statistical significance and clinical utility. It will also be used to refine the study design, protocols, and treatment manuals for the future trial.

This study will be a randomized, single-blind, controlled trial that will compared two types of ED-initiated tobacco treatment to treatment-as-usual. 75 ED patients who meet all inclusion and exclusion criteria will be randomly assigned to one of three groups using a 2:2:1 ratio: Group One: Enhanced Care (n=30), Group Two: Dynamic Referral (n=30), or Group Three: Clinic Referral (n=15). This assignment ratio is being used to maximize experience with the treatments. The two interventions will be delivered by trained counselors and are described below. Baseline measures of smoking and other related variables will be taken during the ED visit. An interviewer blind to study group assignment will conduct follow-up assessments via telephone at 1- and 3-months after the ED visit. We expect a 25% attrition, yielding follow-up data at 3-months on 23, 23, and 11 patients, respectively, for each Group.

Primary outcomes will include: sustained abstinence from the ED visit to the follow-up time periods and 7-day point prevalence abstinence. Secondary outcomes will be: presence of a quit attempt >= 24 hours and readiness to change.

Conditions
Tobacco Use
Being tested
Behavior change counseling
Keywords
tobacco; emergency department; motivation; counseling
Medical subject headings
Tobacco Use, Emergencies

What participants receive

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

  • Behavior change counselingBehavioural

What is being measured

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

  1. Sustained abstinence (from tobacco)

  2. 7-day Point prevalence abstinence

  3. Any quit attempt >= 24 hours

Secondary outcomes (2)
  1. Motivation to quit

  2. Treatment engagement

Timeline

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

  1. First posted15 Nov 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionDec 2006
  4. Study completionDec 2007

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 1/2
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00252902
Sponsor's protocol ID
DA-16698-01
Other IDs
DA-16698-01
Status last verified
Oct 2013
First submitted
11 Nov 2005
Last updated
11 Jan 2017
Results posted
No

Publications

  • Boudreaux ED, Baumann BM, Perry J, Marks D, Francies S, Camargo CA Jr, Ziedonis D. Emergency department initiated treatments for tobacco (EDITT): a pilot study. Ann Behav Med. 2008 Dec;36(3):314-25. doi: 10.1007/s12160-008-9066-3. Epub 2008 Dec 3.

    PubMed 19050988

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Behavior change counseling 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 3 inclusion and 3 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Sustained abstinence (from tobacco). The study lists 3 primary outcomes in all. 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 NCT00252902, which also lists 1 linked publication.

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; AzTrials last refreshed its copy on 8 Nov 2026.

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