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NCT06053762: CEASE Youth

Identify the Usefulness of Peer-facilitated Versus Self-navigated Quit Tobacco Program for Youths.

Status unknown NA Last updated 29 March 2024
What this trial tests

NA trial testing Peer-facilitated tobacco cessation in Tobacco Product Use in 630 participants. Status unknown.

Timeline
1 October 2023
Primary endpoint
1 September 2024
1 December 2024

Quick facts

Lead sponsorMorgan State University
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment630
Start date1 October 2023
Primary completion1 September 2024
Estimated completion1 December 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Morgan State University

Who can join

Adults 14 to 21, any sex, with Tobacco Product Use. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The proposed study is a randomized clinical trial. The overarching goal of the study is to apply Community Based Participatory Research (CBPR) to reduce tobacco use among youth and young adults (14-21 y/o) in Baltimore City through a mixed-method approach adapted to the needs of youth and young adults. This study has partnered with the American Lung Association's Not On Tobacco (N-O-T) program and aims to deliver tobacco cessation classes. The study will target Baltimore City high schools and colleges, prioritizing facilities in underserved inner-city communities. The proposed research consists of a 2-arm trial where participants from four high schools and two colleges will be randomized to peer-facilitated tobacco cessation classes or self-navigated groups. The trial aims to assess the effectiveness of peer-facilitated tobacco cessation intervention compared to self-navigated tobacco cessation in terms of their success rates (quitting and staying quit). The study's primary hypothesis is that the tobacco cessation rate will be equal to or higher in the peer-facilitated arm than in the self-navigated arms. The secondary hypothesis is that the retention rate will be equal to or higher in the peer-facilitated arm compared to the self-navigated arm. CEASE Youth tobacco cessation program is an eight-week program based on the American Lung Association's (ALA) Not On Tobacco (N-O-T) program. The ALA's N-OT program is acknowledged as an accessible and effective option for teen tobacco cessation. Participants in the peer-facilitated group will be given the evidence-based N-O-T program curriculum and provided with virtual materials, information, and resources by their assigned peer facilitators. Virtual tobacco cessation peer motivation sessions will be offered using the digital online platform Zoom, and the peer facilitators will communicate with the participants in between the classes. The participants in the self-navigated group will receive the same ALA N-O-T program curriculum and complete the eight-week sessions, but it will be self-navigated and without peer facilitations. No peer facilitator will be assigned to this group, and the participants will complete the curriculum by themselves. They will also receive other available resources, including information about the local tobacco cessation services available.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing