PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness (NCT03950427) | Clinical Trial Compass
CompletedPhase 4
PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness
United States108 participantsStarted 2019-07-08
Plain-language summary
This is a research study investigating a smoking cessation program tailored for adults with serious mental illness (SMI). The program uses a Videogame-based Physical (VIP) activity, smoking cessation counseling, and medication (bupropion),
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* A diagnosis of a Serious Mental Illness (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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Number of Videogame Sessions Attended
Timeframe: Up to 12 weeks
2
Total Minutes of Videogame Sessions Attended
Timeframe: Up to 12 weeks
3
Mean Score on a Self-report Acceptability Question at Week 6
Timeframe: At week 6
4
Mean Score on a Self-report Acceptability Question at Week 12
Timeframe: At week 12
5
Mean Number of Cigarettes Smoked by Group at Week 6
Timeframe: At week 6
6
Mean Number of Cigarettes Smoked by Group at Week 12
Timeframe: At week 12
7
Point-prevalent Abstinence (PPA)
Timeframe: At week 12
8
Mean Scores at Baseline on the Brief Psychiatric Rating Scale (BPRS)