Inpatient Smoking Cessation Pilot Program

Early Phase 1

Withdrawn

• Conditions: Tobacco Use Cessation
• Interventions: Drug: Nicotine lozenge; Drug: Nicotine gum; Drug: Nicotine patch; Other: Maryland Quitline; Other: John Hopkins Tobacco Treatment Clinic

• Registration Number: NCT05060965
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-09-29
• Primary Completion: 2023-04
• Study Completion: 2023-04
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-10
• Last Update Posted: 2023-08-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

• Pregnant or breast feeding maternal caregivers.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cessation intervention	Nicotine lozenge	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".
Cessation intervention	Nicotine gum	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".
Cessation intervention	Nicotine patch	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".
Cessation intervention	Maryland Quitline	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".
Cessation intervention	John Hopkins Tobacco Treatment Clinic	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".

Primary Outcome Measures

Name	Time	Method
Change in Self-reported attempts to quit smoking	Baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months	Change in caregiver self-reported tobacco cessation attempt in the past 14-days.

Secondary Outcome Measures

Name	Time	Method
Change in Frequency of usage of outpatient tobacco cessation services	Baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months	Change in frequency of caregiver self-reported usage of outpatient tobacco cessation services (Maryland Quitline or Johns Hopkins Tobacco Treatment Clinic).
Change in Usage of nicotine replacement therapy products	Baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months	Change in caregiver self-reported usage of nicotine replacement therapy in the past 14-days.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States