Inpatient Smoking Cessation Pilot Program

NCT05060965 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: IRB00208192
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Cessation

Outcome Measures

Primary Outcomes (1)

• Change in Self-reported attempts to quit smoking

  Change in caregiver self-reported tobacco cessation attempt in the past 14-days.

  Baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months

Secondary Outcomes (2)

• 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 Usage of nicotine replacement therapy products

  Baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months

Study Arms (1)

Cessation intervention

EXPERIMENTAL

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".

Drug: Nicotine lozenge; Drug: Nicotine gum; Drug: Nicotine patch; Other: Maryland Quitline; Other: John Hopkins Tobacco Treatment Clinic

Interventions

Nicotine lozenge DRUG

Nicotine replacement therapy

Cessation intervention

Nicotine gum DRUG

Nicotine replacement therapy

Cessation intervention

Nicotine patch DRUG

Nicotine replacement therapy

Cessation intervention

Maryland Quitline OTHER

Telephone-based tobacco cessation service

Cessation intervention

John Hopkins Tobacco Treatment Clinic OTHER

Clinic-based tobacco cessation service

Cessation intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breast feeding maternal caregivers.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Tobacco Use Cessation

Interventions

Tobacco Use Cessation Devices; Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Mandeep S. Jassal, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 29, 2021
• Study Start: October 1, 2019
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)