Emergency Department Management of Tobacco Use Disorder

NCT ID: NCT06350175

Last Updated: 2025-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-31

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tobacco Use Disorder Tobacco Use Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Nicotine Replacement Therapy Agent

Intervention Type COMBINATION_PRODUCT

The NRT Agents-- 21mg nicotine patches (x14) and 2 mg nicotine lozenges (\~210).

West Virginia Quit Line

Intervention Type OTHER

Instructional Pamphlets and contact information for the WV QL. A telehealth line set up to assist people of WV to quit smoking.

Control Non NRT Therapy

Subject will be provided with a box/bag containing a WV QL fact sheet/contact information.

Group Type OTHER

West Virginia Quit Line

Intervention Type OTHER

Instructional Pamphlets and contact information for the WV QL. A telehealth line set up to assist people of WV to quit smoking.

Interventions

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Nicotine Replacement Therapy Agent

The NRT Agents-- 21mg nicotine patches (x14) and 2 mg nicotine lozenges (\~210).

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West Virginia University

OTHER

Sponsor Role lead

Responsible Party

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Bradley End

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bradley End

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Other Identifiers

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2212697123

Identifier Type: -

Identifier Source: org_study_id

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