Inpatient Smoking Cessation Pilot Program

NCT ID: NCT05060965

Last Updated: 2023-08-15

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WITHDRAWN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

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2023-04-30

Brief Summary

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The investigators are implementing a stepwise approach to cessation with a public health focus to improve health outcomes for the investigators' pediatric patients. The investigators are focusing on addressing caregiver smoking as a modifiable risk factor during time of child's hospitalization as a window of opportunity to provide counseling and education to families on secondhand and third hand smoke exposure as well as information on NRT products to heighten caregiver contemplation for quitting. One of the central goals of the investigators' project is to increase immediate access to Nicotine Replacement Therapy (NRT) resources for families during hospitalization which pediatric providers could potentially dose and prescribe to caregivers who are screened positive for smoking. Long-term cessation care is provided by referrals to both the MD Quitline and the John Hopkins Tobacco Treatment Clinic. Both are provided to allow participants options that the participants would find preferable from an insurance and provider perspective.

Detailed Description

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Conditions

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Tobacco Use Cessation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Cessation intervention

All participants will receive nicotine replacement therapy and a referral to both Maryland Quitline and Johns Hopkins Tobacco Treatment Clinic for continued cessation care.

Nicotine replacement therapy: Nicoderm patches, gum, lozenges

* Low nicotine dependence: Lozenge (2 mg) or Gum (2 mg) or Patch (7 mg)
* Moderate nicotine dependence: Patch (14 mg) and Lozenge (2 mg) or Gum (2 mg)
* High nicotine dependence: Patch (21 mg) and Lozenge (4 mg) or Gum (4 mg)

Regardless of the level of nicotine addiction and subsequent dose of nicotine replacement therapy (NRT), participants of this trials are described as "recipients of NRT products".

Group Type EXPERIMENTAL

Nicotine lozenge

Intervention Type DRUG

Nicotine replacement therapy

Nicotine gum

Intervention Type DRUG

Nicotine replacement therapy

Nicotine patch

Intervention Type DRUG

Nicotine replacement therapy

Maryland Quitline

Intervention Type OTHER

Telephone-based tobacco cessation service

John Hopkins Tobacco Treatment Clinic

Intervention Type OTHER

Clinic-based tobacco cessation service

Interventions

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Nicotine lozenge

Nicotine replacement therapy

Intervention Type DRUG

Nicotine gum

Nicotine replacement therapy

Intervention Type DRUG

Nicotine patch

Nicotine replacement therapy

Intervention Type DRUG

Maryland Quitline

Telephone-based tobacco cessation service

Intervention Type OTHER

John Hopkins Tobacco Treatment Clinic

Clinic-based tobacco cessation service

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Caregivers of patients on an inpatient unit at Johns Hopkins Children's Center who self-identify as tobacco users and wish to initiate tobacco cessation

Exclusion Criteria

* Pregnant or breast feeding maternal caregivers.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mandeep S. Jassal, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00208192

Identifier Type: -

Identifier Source: org_study_id

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