Emergency Department Management of Tobacco Use Disorder

December 31, 2024 updated by: Bradley End, West Virginia University

Emergency Department Based Management of Tobacco Use Disorder

The objective of this study is to determine the effectiveness of ED initiated NRT on tobacco cessation point abstinence rates as reported by patients at 2 weeks and 1 month post randomization, and continued abstinence rates at 3 months compared to standard of care therapy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Current daily use cigarettes greater than or equal to ½ pack per day
  • Stable for discharge from the ED
  • Able and willing to complete telephone/electronic follow up at scheduled intervals
  • Reported English speaking

Exclusion Criteria:

  • Patients enrolled in specific health insurance plans (PEIA, The Health Plan or Medicaid medical insurance)
  • WVU students
  • Medically unstable patients
  • Patients with clinical decompensation or who are admitted to the hospital
  • Patients who are discharged to residential treatment facilities for detoxification
  • Uncontrolled psychiatric disorder or psychiatric emergency
  • Individuals who are unable to provide consent
  • Incarcerated individuals
  • Language barrier
  • Currently pregnant or attempting to become pregnant
  • Presenting for evaluation of sexual assault
  • Known allergy or previous intolerance to nicotine replacement therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nicotine Replacement Therapy (NRT)
Subject provided with a 2-week supply of NRT and a West Virginia Quit Line (WV QL) fact sheet/contact information.
Combination product: Nicotine Replacement Therapy Agent
The NRT Agents-- 21mg nicotine patches (x14) and 2 mg nicotine lozenges (~210).
Other: West Virginia Quit Line
Instructional Pamphlets and contact information for the WV QL. A telehealth line set up to assist people of WV to quit smoking.
Other: Control Non NRT Therapy
Subject will be provided with a box/bag containing a WV QL fact sheet/contact information.
Other: West Virginia Quit Line
Instructional Pamphlets and contact information for the WV QL. A telehealth line set up to assist people of WV to quit smoking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Continued Abstinence Rate (2 weeks)
Time Frame: 2 Weeks post initial dose
Percentage of subjects who self-report continued abstinence in tobacco use at 2 weeks from initial dose given during the ED visit.
2 Weeks post initial dose
Percentage of Continued Abstinence Rate (1 month)
Time Frame: 1 Month post initial dose
Percentage of subjects who self-report continued abstinence in tobacco use at 1 month from initial dose given during the ED visit.
1 Month post initial dose
Percentage of Continued Abstinence Rate (3 months)
Time Frame: 3 Months post initial dose
Percentage of subjects who self-report continued abstinence in tobacco use at 3 months from initial dose given during the ED visit.
3 Months post initial dose
Patient Health Questionnaire 2 (Baseline)
Time Frame: Baseline
A validated instrument to assess the frequency of depression and anhedonia screen for depression, scores can range from 0 to 6, with each item scored from 0 (not at all) to 3 (nearly every day). Scores greater than or equal to typically indicate depression.
Baseline
Patient Health Questionnaire 2 (3 months from baseline)
Time Frame: 3 months from baseline
A validated instrument to assess the frequency of depression and anhedonia screen for depression, scores can range from 0 to 6, with each item scored from 0 (not at all) to 3 (nearly every day). Scores greater than or equal to typically indicate depression.
3 months from baseline
Heaviness of Smoking Index (Baseline)
Time Frame: Baseline
A validated measure used to determine the level of nicotine addiction, with a scale of 0-6 (3 indicates moderate addiction, >5 is severe)
Baseline
Heaviness of Smoking Index (3 months from baseline)
Time Frame: 3 months from baseline
A validated measure used to determine the level of nicotine addiction, with a scale of 0-6 (3 indicates moderate addiction, >5 is severe)
3 months from baseline
Richmond Test (Baseline)
Time Frame: Baseline
A validated instrument to assess motivation to quit smoking. This is scored on a 0-10 scale with 5-6 indicating moderate motivation to quit and 7+ indicating strong motivation to quit.
Baseline
Richmond Test (3 months from baseline)
Time Frame: 3 months from baseline
A validated instrument to assess motivation to quit smoking. This is scored on a 0-10 scale with 5-6 indicating moderate motivation to quit and 7+ indicating strong motivation to quit.
3 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Virginia University

Investigators

  • Principal Investigator: Bradley End, West Virginia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 31, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2212697123

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tobacco Use Disorder

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  • Washington University School of Medicine
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  • University of Utah
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  • Harvard School of Public Health (HSPH)
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  • Johns Hopkins University
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    Recruiting
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  • University of California, San Francisco
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    Completed
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  • University of California, San Francisco
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    An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers (POP-6)
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  • Centre for Addiction and Mental Health
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  • Indiana University
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  • Rutgers, The State University of New Jersey
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