Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings

NCT05030272 | Completed DMC FDA Device

• 2 other identifiers: IRB00110770R01DA047301
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Tobacco Use Disorder; Mental Illness; Recurring Major Depressive Disorder; Bipolar Disorder; Schizophrenia; Schizoaffective Disorder; Persistent Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• CO-verified 7-day point-prevalence abstinence at 6-month follow-up

  Abstinence is determined by a self-report of not smoking any tobacco product for greater than or equal to 7 days prior to Week 24 and biochemically verified by an expired carbon monoxide breath test reading of \< 5 ppm at Week 24. If the participant does not meet both criteria, they are not considered abstinent. As per convention, participants are assumed to be smoking if they report smoking at the time-point, cannot be reached to provide data at the time-point, fail to provide a breath sample at the time-point, or provide a breath sample at the time-point that is greater than or equal to 5 ppm.

  6 month follow-up

Secondary Outcomes (18)

• Change in average number of cigarettes smoked per day

  1 month follow-up

• Change in average number of cigarettes smoked per day

  3 month follow-up

• Change in average number of cigarettes smoked per day

  6 month follow-up

• Average number of quit attempts per group

  1 month follow-up

• Average number of quit attempts per group

  3 month follow-up

Other Outcomes (12)

• Average app usability scores

  1 month follow-up

• Average user experience scores

  1 month follow-up

• Average user experience scores

  3 month follow-up

Study Arms (2)

"Quit on the Go" (formerly "Learn to Quit")

EXPERIMENTAL

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. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 5-10 week course of NRT gum (or Nicotine Lozenges if unable to use gum). Participants also receive technical smartphone coaching for the first 4 weeks of the study.

Device: Quit on the Go App (formerly "Learn to Quit " App); Drug: Nicotine patch; Behavioral: Smartphone coaching; Drug: Nicotine gum; Drug: Nicotine Lozenges

Brief Advice (Standard of Care)

OTHER

Brief Advice and Combined Nicotine Replacement Therapy (patches and gum or lozenges) has been recommended by the US Clinical Practice Guidelines for patients with psychiatric illness. 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. The intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 5-10 week course of NRT gum (or Nicotine Lozenges if unable to use gum).

Behavioral: Brief advice; Drug: Nicotine patch; Drug: Nicotine gum; Drug: Nicotine Lozenges

Interventions

Quit on the Go App (formerly "Learn to Quit " App) DEVICE

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.

"Quit on the Go" (formerly "Learn to Quit")

Brief advice BEHAVIORAL

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.

Brief Advice (Standard of Care)

Nicotine patch DRUG

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.

Also known as: NRT

"Quit on the Go" (formerly "Learn to Quit"); Brief Advice (Standard of Care)

Smartphone coaching BEHAVIORAL

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.

"Quit on the Go" (formerly "Learn to Quit")

Nicotine gum DRUG

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.

Also known as: NRT

"Quit on the Go" (formerly "Learn to Quit"); Brief Advice (Standard of Care)

Nicotine Lozenges DRUG

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.

Also known as: NRT

"Quit on the Go" (formerly "Learn to Quit"); Brief Advice (Standard of Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, recurring major depressive disorder or Persistent Depressive Disorder
• Functional impairment as indicated by a score of 2 or greater on the WHODAS 8 item version
• Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months;
• Desire to quit smoking as indicated by self-reported serious intention to quitting tobacco within the next 6 months;
• Age 18 and older;
• Willing and medically eligible to use NRT;
• Currently receiving psychiatric treatment and intent to receive treatment for the duration of the study (therapy, medications, etc.).

You may not qualify if:

• Problematic substance use, as defined by the Addiction Severity Index, within the last 30 days, twice within the past 6 months, or hospitalization for substance abuse within the past year.
• Current acute psychotic episode or unsafe to participate in the study as defined by the Mini International Neuropsychiatric Interview for Psychotic Disorders (Sheehan et al., 1998);
• Being pregnant or the intention to become pregnant in the next 6 months;
• Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation;
• Currently using e-cigarettes or other tobacco products besides cigarettes \> 10 days in the past 30 days.
• Unsafe to participate in the study due to moderate or high risk of suicide determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Screen Version, defined as answering 'yes' to both question 3 for the last month and 'yes' to question 6 for lifetime (moderate risk), or 'yes' to questions 4 and 5 for the recent month, or 'yes' to question 6 for the last 3 months (high risk).

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

University at Buffalo

Buffalo, New York, 14260-1660, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Mental Disorders; Bipolar Disorder; Schizophrenia; Psychotic Disorders

Interventions

Crisis Intervention; Tobacco Use Cessation Devices; Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Bipolar and Related Disorders; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Roger Vilardaga, PhD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 1, 2021
• Study Start: September 21, 2021
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 27, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)