Comparing two methods to help people with mental illness quit smoking
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
This study is testing if a special smoking cessation app can help people with serious mental illnesses quit smoking better than regular methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 3 sites (Buffalo, New York and 2 other locations) |
| Trial ID | NCT05030272 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a tailored smoking cessation app, Quit on the Go, compared to standard smoking cessation interventions for individuals with serious mental illness (SMI). Conducted across three sites, the study aims to determine if the app can improve smoking cessation rates among participants diagnosed with conditions such as schizophrenia, bipolar disorder, and major depressive disorder. The trial builds on previous pilot research that showed promising results in engagement and cessation rates, focusing on delivering effective interventions to a vulnerable population. Participants will receive various support methods, including nicotine replacement therapy and smartphone coaching.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a DSM-5 diagnosis of schizophrenia, bipolar disorder, or recurring major depressive disorder who are motivated to quit smoking.
Not a fit: Patients with problematic substance use or those experiencing an acute psychotic episode may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve smoking cessation rates among individuals with serious mental illness, enhancing their overall health and quality of life.
How similar studies have performed: Previous studies have shown success with tailored smoking cessation interventions for similar populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, recurring major depressive disorder or Persistent Depressive Disorder 2. Functional impairment as indicated by a score of 2 or greater on the WHODAS 8 item version 3. Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months; 4. Desire to quit smoking as indicated by self-reported serious intention to quitting tobacco within the next 6 months; 5. Age 18 and older; 6. Willing and medically eligible to use NRT; 7. Currently receiving psychiatric treatment and intent to receive treatment for the duration of the study (therapy, medications, etc.). Exclusion Criteria 1. 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. 2. 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); 3. Being pregnant or the intention to become pregnant in the next 6 months; 4. Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation; 5. Currently using e-cigarettes or other tobacco products besides cigarettes \> 10 days in the past 30 days. 6. 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).
Where this trial is running
Buffalo, New York and 2 other locations
- University at Buffalo — Buffalo, New York, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Active_not_recruiting)
- Wake Forest Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Roger Vilardaga, PhD — Wake Forest University
- Study coordinator: Roger Vilardaga, PhD
- Email: rvilarda@wakehealth.edu
- Phone: 919 681 3441
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.