Mobile App for Smoking Cessation and Mental Health

NCT04887558 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 13388
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Adults with serious mental illness (SMI) represent 5% of the United States population, yet account for 30% of all cigarettes smoked and are 2 to 3 times more likely to be dependent on nicotine compared with the general population. There are also significant disparities in quitting: 24% of lifetime smokers with SMI report not smoking within the past year compared with 52% of lifetime smokers without SMI. Two barriers partly explain the large disparity in smoking cessation rates between adults with and without SMI. First, there is a lack of high-quality, evidence-based interventions for smoking cessation in populations with SMI, which may be because adults with SMI are often excluded from clinical trials, despite evidence indicating that SMI is highly comorbid with smoking. Second, clinicians and staff within mental health settings generally do not have the resources or appropriate training to provide smoking cessation treatments to patients with SMI. Smartphone-based mobile health applications for smoking cessation could significantly improve cessation rates for adults with SMI. However, smoking cessation apps are underutilized by smokers with SMI partly because the apps are not designed for their unique needs. This study aims to conduct a pilot randomized controlled trial to evaluate the feasibility of an innovative, evidence-based smoking cessation app tailored for smokers with SMI. Seventy-five treatment-seeking smokers with SMI who will be referred from the Oklahoma Department of Mental Health and Substance Abuse Services (25 per group), a publicly funded outpatient psychiatry treatment program, will be randomly assigned to receive either (1) QuitGuide, a free smoking cessation app developed by the National Cancer Institute, (2) a smoking cessation app that tracks and automatically intervenes upon psychological distress during a quit attempt and delivers real-time intervention messages tailored to the current level of lapse risk and current lapse triggers (Smart-T Mental Health; STMH), or (3) the STMH app with additional messaging focused on increasing adherence to nicotine replacement medications (STMH+). All study conditions will be followed for 5 weeks (1-week pre-cessation and 4 weeks post-cessation), receive nicotine replacement therapy, and complete smartphone-based survey assessments using ecological momentary assessment procedures.

Conditions

Smoking Cessation; Mental Illness

Outcome Measures

Primary Outcomes (1)

• Biochemically-Verified Smoking Cessation

  Biochemically confirmed 7-day point prevalence abstinence using the CO criteria cutoff of ≤ 7 ppm

  4 weeks

Secondary Outcomes (8)

• Change in smoking urge

  4 weeks

• Change in stress

  4 weeks

• Change in cigarette availability

  4 weeks

• Change in cessation motivation

  4 weeks

• Change in depression

  4 weeks

Study Arms (3)

NCI QuitGuide and NRT

ACTIVE COMPARATOR

The National Cancer Institute's QuitGuide app is a free smartphone app and is one of few apps that includes many of the recommendations detailed in the Clinical Practice Guideline. The QuitGuide app aims to help smokers understand their smoking patterns and develop the skills needed to quit smoking. QuitGuide provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. All participants will receive free NRT.

Combination Product: QuitGuide + NRT

Smart-T Mental Health and NRT

EXPERIMENTAL

Smart-T Mental Health provides smoking cessation and mental health content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. The Smart-T app contains multiple components including an EMA delivery and data transfer system, automated messages based upon EMA responses, and on-demand content. All participants will receive NRT.

Combination Product: Smart-T Mental Health and NRT

Smart-T Mental Health+ and NRT

EXPERIMENTAL

Smart-T Mental Health provides smoking cessation and mental health content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. During the pre-quit and post-quit period, the app will also send messages that encourage the use of the nicotine patch and lozenges according to recommended practices. The Smart-T app contains multiple components including an EMA delivery and data transfer system, automated messages based upon EMA responses, and on-demand content. All participants will receive free NRT.

Combination Product: Smart-T Mental Health+ and NRT

Interventions

Smart-T Mental Health+ and NRT COMBINATION_PRODUCT

Smart-Treatment Mental Health App+NRT adherence messages and Nicotine Replacement Therapy

Smart-T Mental Health+ and NRT

QuitGuide + NRT COMBINATION_PRODUCT

NCI QuitGuide Treatment App and Nicotine Replacement Therapy

NCI QuitGuide and NRT

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• valid residential address to mail study materials
• willingness to quit smoking 7 days after the randomization phone call
• currently smoke ≥ 10 cigarettes per day
• willing and medically eligible to use combination NRT
• agree to complete daily EMAs and thrice-weekly CO tests on a study provided or personal smartphone
• agree to complete the 5-week post-quit follow-up assessment (i.e., smartphone based quantitative survey and qualitative interview via phone call).

You may not qualify if:

• Individuals who score ≥ 8 on the Cognitive Impairment Test, which indicates severe cognitive impairment,
• Pregnant or intend to become pregnant during the study period.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Oklahoma Department of Mental Health and Substance Abuse Services

Oklahoma City, Oklahoma, 73105, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Mental Disorders

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Michael Businelle, PhD

  TSET Health Promotion Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 14, 2021
• Study Start: December 14, 2021
• Primary Completion: January 6, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)