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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05060965
Other study ID # IRB00208192
Secondary ID
Status Withdrawn
Phase Early Phase 1
First received
Last updated
Start date October 1, 2019
Est. completion date April 2023

Study information

Verified date August 2023
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2023
Est. primary completion date April 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nicotine lozenge
Nicotine replacement therapy
Nicotine gum
Nicotine replacement therapy
Nicotine patch
Nicotine replacement therapy
Other:
Maryland Quitline
Telephone-based tobacco cessation service
John Hopkins Tobacco Treatment Clinic
Clinic-based tobacco cessation service

Locations

Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

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