450
Participants
Start Date
September 21, 2021
Primary Completion Date
January 31, 2026
Study Completion Date
January 31, 2026
"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.
Wake Forest Health Sciences, Winston-Salem
Duke University, Durham
University at Buffalo, Buffalo
National Institute on Drug Abuse (NIDA)
NIH
Wake Forest University Health Sciences
OTHER