Clinical Research Directory
Browse clinical research sites, groups, and studies.
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
Sponsor: Wake Forest University Health Sciences
Summary
The study team will conduct a Multisite Randomized Controlled Trial to evaluate the advantages and disadvantages of two approaches for quitting smoking among people with serious mental illness (SMI). The study will compare a novel app tailored to people with SMI, Quit on the Go, to a standard of care smoking cessation intervention. We will test the effectiveness of the Quit on the Go app, an intervention that has demonstrated feasibility and acceptability in the target population, as a tool for smoking cessation in people with SMI. Participants with SMI will be recruited across 3 sites (Duke University, Univ. at Buffalo, and Wake Forest University).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
343
Start Date
2021-09-21
Completion Date
2025-12-30
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
Quit on the Go App (formerly "Learn to Quit " App)
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms.
Brief advice
Brief Advice will consist of 20 minutes of guidance about the use of nicotine replacement therapy, and strategies to initiate and maintain a quit attempt.
Nicotine patch
All participants will receive an 8-week course of transdermal nicotine patches. The first 4 weeks of use will be 21mg/24 hours, followed by 2 weeks of 14mg/24 hours patches, and finally 2 weeks of 7mg/24 hours patches.
Smartphone coaching
Participants randomized to the smartphone app intervention will receive 4 weeks of smartphone coaching given by research staff. The coaching is meant to be a time to address any issues that may rise with the participants' study smartphone or app.
Nicotine gum
Each participant enrolled will be given NRT gum (5-10week course) to be taken orally as nicotine cravings arise. Depending on participants' nicotine dependence, they will receive either the 2mg or 4mg (if they smoke within the first 30 minutes of waking) gum pieces per package instructions. We will direct subjects to use them for the first weeks following their quit date, using no more than one every 1-2 hours.
Nicotine Lozenges
In cases where participants are unable to chew nicotine gum, lozenges will be sent as a replacement of Nicotine gum. Depending on participants' nicotine dependence, they will receive either the 2mg or 4mg (if they smoke within the first 30 minutes of waking) lozenge pieces per package instructions. We will direct subjects to use them for the first weeks following their quit date, using no more than one every 1-2 hours.
Locations (3)
University at Buffalo
Buffalo, New York, United States
Duke University
Durham, North Carolina, United States
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States