NCT05181072: CEASE

Identify the Usefulness of In-person and Virtual Quit Smoking Programs

Completed NA Last updated 29 March 2024

What this trial tests

NA trial testing Enhanced in-person peer-motivation smoking cessation in Cigarette Smoking in 392 participants. Completed in 23 December 2023.

Timeline

5 January 2022

Primary endpoint
23 December 2023

23 December 2023

Quick facts

Lead sponsor	Morgan State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	392
Start date	5 January 2022
Primary completion	23 December 2023
Estimated completion	23 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Enhanced in-person peer-motivation smoking cessation
• Virtual peer-motivation smoking cessation

Conditions studied

• Cigarette Smoking — all drugs for Cigarette Smoking →
• Tobacco Use — all drugs for Tobacco Use →

Sponsor

Morgan State University

Who can join

21 and older, any sex, with Cigarette Smoking or Tobacco Use. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a randomized community-based trial adapted to the needs of adults aged 21 years or older that is designed by an existing research partnership called Communities Engaged and Advocating for Smoke-free Environments (CEASE). The overarching goal of the proposed study is to apply a community-based approach to reduce tobacco use among low-income communities in Baltimore City. The study setting represents three underserved communities in Baltimore City: the Oldtown/Middle East, the Waverlies, Poppleton/The Terraces/Hollins Market, and Washington Village/Pigtown. Poppleton/The Terraces/Hollins Market and Washington Village/Pigtown will be considered as one community. The three communities have been randomly allocated to one of the three arms of the study: 1) Virtual intervention, 2) Enhanced in-person intervention, and 3) The control community.

The Waverlies was assigned to virtual, the Middle East was assigned to be the in-person group, and Poppleton/The Terraces/Hollins Market and Washington Village/Pigtown became the self-help/control group. The goal of the trial is to assess the effectiveness of virtual versus in-person versions of a smoking cessation program in terms of their success rates (quitting and staying quit). The study's primary hypothesis is that the smoking cessation rate will be equal to or higher in the virtual peer-motivation arm than the in-person and self-help/ control arms. The secondary hypothesis is that the retention rate will differ among the three interventions (virtual peer-motivation, enhanced in-person peer-motivation, and self-help/control community).

Virtual and enhanced in-person versions of the CEASE Today Peer-Motivation Intervention were developed and pilot-tested during the first and second years based on local data and input from partnering communities. The enhanced in-person intervention will utilize the existing CEASE Today Tobacco Cessation Manual with improvements. The virtual intervention will use a newly developed CEASE website with smoking cessation modules and lessons that mirror the CEASE Today Tobacco Cessation Manual. Trained peer-motivators will deliver the intervention and be actively involved in recruiting the participants, motivation enhancement, group facilitation, and counseling.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.