Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings

NAActive, not recruitingINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

September 21, 2021

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Tobacco Use DisorderMental IllnessRecurring Major Depressive DisorderBipolar DisorderSchizophreniaSchizoaffective DisorderPersistent Depressive Disorder
Interventions
DEVICE

"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.

BEHAVIORAL

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.

DRUG

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.

BEHAVIORAL

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.

DRUG

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.

DRUG

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.

Trial Locations (3)

27157

Wake Forest Health Sciences, Winston-Salem

27705

Duke University, Durham

14260-1660

University at Buffalo, Buffalo

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Wake Forest University Health Sciences

OTHER