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Nicotine Replacement Therapy
Nicotine patch for Quitting Smoking
Phase < 1
Waitlist Available
Led By Mandeep S. Jassal, MD, MPH
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial focuses on helping caregivers of hospitalized children quit smoking. Caregivers receive advice about the dangers of smoking around kids and are given nicotine patches or gum to help them stop. The goal is to improve the health of both the children and their caregivers by reducing exposure to harmful smoke. Nicotine patches and gum have been shown to be effective in helping people quit smoking.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Self-reported attempts to quit smoking
Secondary study objectives
Change in Frequency of usage of outpatient tobacco cessation services
Change in Usage of nicotine replacement therapy products
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cessation interventionExperimental Treatment5 Interventions
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".
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine gum
2015
Completed Phase 4
~2410
Nicotine patch
2015
Completed Phase 4
~6130
Nicotine lozenge
2019
Completed Phase 4
~1940
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,321 Previous Clinical Trials
14,873,941 Total Patients Enrolled
Mandeep S. Jassal, MD, MPHPrincipal InvestigatorJohns Hopkins University
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