Smoking cessation program for adults with serious mental illness
PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness
This study is testing a special program that combines video games, counseling, and medication to help adults with serious mental illness quit smoking.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT03950427 on ClinicalTrials.gov |
What this trial studies
This study focuses on a smoking cessation program specifically designed for adults with serious mental illness. It combines a videogame-based physical activity, counseling for smoking cessation, and medication (bupropion or nicotine replacement therapy) to help participants quit smoking. Participants will engage in counseling sessions and either active or sedentary videogame groups over a 12-week period, with multiple assessments to evaluate their progress. The study aims to understand how this tailored approach affects smoking cessation outcomes in this population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of serious mental illness who smoke at least five cigarettes per day.
Not a fit: Patients who are currently pregnant or breastfeeding, or those with a seizure disorder, may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve smoking cessation rates among adults with serious mental illness.
How similar studies have performed: Other studies have shown promise in using tailored interventions for smoking cessation in similar populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A diagnosis of a SMI\* * 18 years and older * Smoking at least five cigarettes per day for the past 6 months * Willingness to set a quit date * Not currently taking bupropion or using nicotine replacement therapy (NRT) * Current participant in the residential or day treatment program at a Progress Foundation program with the intention to continue in the residential or day treatment program for at least the 12 week intervention period * Capacity to consent. * SMI is characterized by the American Psychological Association as distinct conditions that require routine management, produce functional impairment, and interfere with quality of life. Individuals that typically meet the criteria of SMI have illnesses that include schizophrenia, schizoaffective disorder, psychotic disorders, major depressive disorders, bipolar disorders, and borderline personality disorder. Exclusion Criteria: * Currently pregnant or breastfeeding * Diagnosis of seizure disorder, history of anorexia/bulimia, undergoing abrupt discontinuation of ethanol or sedatives, other conditions that increase seizure risk (e.g., arteriovenous malformation (AVM), severe head injury, central nervous system (CNS) tumor) * use of Monoamine oxidase (MAO) inhibitors (concurrently or within 14 days of discontinuing either bupropion or the MAO inhibitor) * Planning to become pregnant during the study period * Previous participation in the videogame-based physical activity intervention. * Known medical conditions or other physical problems that need special attention in an exercise program (e.g. prior myocardial infarction, uncontrolled hypertension, history of angioplasty, history of angina, use of nitroglycerin to treat angina)
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Heather Leutwyler, PhD — University of California, San Francisco
- Study coordinator: Heather Leutwyler, PhD
- Email: heather.leutwyler@ucsf.edu
- Phone: 415-514-1524
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.