PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness (PARQuit)

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),

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Tobacco Use Disorder; Mental Illness; Smoking, Tobacco
• Intervention / Treatment: Behavioral: Videogame-based physical activity; Drug: Bupropion; Behavioral: Counseling; Behavioral: Sedentary videogame

Detailed Description

The purpose of this study is to learn more about how adults with serious mental illness respond to a smoking cessation program combining a game-based Physical activity, counseling for smoking cessation, and a medication (bupropion or NRT) for smoking cessation.

Study participants will receive counseling to quit smoking and a medication to help decrease cravings and withdrawal. Additionally, participants will be randomly selected to participate in either a game-based physical activity group or a game group where the participants sit to play the games.

Participants will be in this study for 12 weeks total. There are 3 assessment visits (2 hours each) at the beginning of the study, 6 weeks after starting, and at the end of the 12 weeks. There will be 8 30- minute counseling sessions during the 12 weeks. The hour-long videogame groups will be held 3 times a week for 12 weeks (36 sessions). Upon completion of the 12-week program, there will be a 1-2 hour group interview. The total time commitment is 48 hours over the course of the 12-week study.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143-0610
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sedentary Videogame Group; The sedentary videogame group will play games while seated using the Xbox 360 game system (without the Kinect sensor) or seated outdoors in a public park. Each sedentary videogame group will be facilitated by study staff. Participants in this group will also receive bupropion and counseling for smoking cessation.	Drug: Bupropion; Bupropion; Other Names: Wellbutrin; Zyban; Behavioral: Counseling; Counseling for smoking cessation; Behavioral: Sedentary videogame; sedentary videogame
Active Comparator: Game-based Physical Activity Group; The game-based physical activity group, will play active games using the Kinect for Xbox 360 game system or outdoors in a public park. Each game group will be facilitated by the study coordinator, the principal investigator or other study staff. Participants in this group will also receive bupropion and counseling for smoking cessation.	Behavioral: Videogame-based physical activity; videogame-based physical activity; Drug: Bupropion; Bupropion; Other Names: Wellbutrin; Zyban; Behavioral: Counseling; Counseling for smoking cessation
Active Comparator: CLOSED - Videogame-based Physical (VIP) Active Group, Pre-COVID; The videogame-based physical activity group will play active videogames using the Kinect for Xbox 360 game system and participate in physical activity. Each videogame group will be facilitated by the study coordinator, the principal investigator or other study staff. Participants in this group will also receive bupropion and counseling for smoking cessation.	Behavioral: Videogame-based physical activity; videogame-based physical activity; Drug: Bupropion; Bupropion; Other Names: Wellbutrin; Zyban; Behavioral: Counseling; Counseling for smoking cessation
Placebo Comparator: CLOSED - VIP Sedentary Group, Pre-COVID; The sedentary videogame group will play videogames while seated using the Xbox 360 game system using the Kinect sensor. Each sedentary videogame group will be facilitated by study staff. Participants in this group will also receive bupropion and counseling for smoking cessation.	Drug: Bupropion; Bupropion; Other Names: Wellbutrin; Zyban; Behavioral: Counseling; Counseling for smoking cessation; Behavioral: Sedentary videogame; sedentary videogame

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Videogame Sessions Attended	Feasibility will be measured with a total count of sessions attended. The graduate student researcher (GSR) will document participant attendance.	Up to 12 weeks
Total Minutes of Videogame Sessions Attended	Feasibility will be measured with a sum of minutes attended. The GSR will monitor and document the times when participants enter and leave the sessions.	Up to 12 weeks
Mean Score on a Self-report Acceptability Question at Week 6	Acceptability was assessed through a single question asked of participants "How enjoyable were the games?" with participants' responses on a Likert scale from 1 (Did not like at all) to 5 (Liked very much). The mean and standard deviation of the response to the question will be calculated for a possible total score range of 1 to 5, with higher scores indicating a higher degree of acceptability.	At week 6
Mean Score on a Self-report Acceptability Question at Week 12	Acceptability was assessed through a single question asked of participants "How enjoyable were the games?" with participants' responses on a Likert scale from 1 (Did not like at all) to 5 (Liked very much). The mean and standard deviation of the response to the question will be calculated for a possible total score range of 1 to 5, with higher scores indicating a higher degree of acceptability.	At week 12
Mean Number of Cigarettes Smoked by Group at Week 6	The investigators will record the number of cigarettes per participant, even a puff, smoked in the past week (7-day abstinence) or use of any form of tobacco or alternative tobacco product e.g., e-cigarette or heat not burn. Salivary cotinine levels will be measured to determine abstinence from smoking.	At week 6
Mean Number of Cigarettes Smoked by Group at Week 12	The investigators will record the number of cigarettes per participant, even a puff, smoked in the past week (7-day abstinence) or use of any form of tobacco or alternative tobacco product e.g., e-cigarette or heat not burn. Salivary cotinine levels will be measured to determine abstinence from smoking.	At week 12
Point-prevalent Abstinence (PPA)	Number of participants reporting not using tobacco at week 12	At week 12
Mean Scores at Baseline on the Brief Psychiatric Rating Scale (BPRS)	The Semi-Structured Interview for Brief Psychiatric Rating Scale is completed by the PI or trained research staff and assesses the number and severity of psychiatric symptoms. It consists of 24 items that are rated from 1 (not present) to 7 (extremely severe), and the items are summed for a total psychopathology score, with a possible range from 24-168 and a higher score indicating a higher severity of illness.	At Baseline (1 day)
Mean Scores at Week-6 on the Brief Psychiatric Rating Scale (BPRS)	The Semi-Structured Interview for Brief Psychiatric Rating Scale is completed by the PI or trained research staff and assesses the number and severity of psychiatric symptoms. It consists of 24 items that are rated from 1 (not present) to 7 (extremely severe), and the items are summed for a total psychopathology score, with a possible range from 24-168 and a higher score indicating a higher severity of illness.	At week 6
Mean Scores at Week-12 on the Brief Psychiatric Rating Scale (BPRS)	The Semi-Structured Interview for Brief Psychiatric Rating Scale is completed by the PI or trained research staff and assesses the number and severity of psychiatric symptoms. It consists of 24 items that are rated from 1 (not present) to 7 (extremely severe), and the items are summed for a total psychopathology score, with a possible range from 24-168 and a higher score indicating a higher severity of illness.	At week 12

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Tobacco Related Disease Research Program
• Investigators: Principal Investigator: Heather Leutwyler, PhD, University of California, San Francisco

Publications and helpful links

General Publications

• Whitmore H, Hubbard E, Cooper B, Leutwyler H. Randomized Controlled Trial of a Group-Based Smoking Cessation Intervention for Adults With Serious Mental Illness. Nicotine Tob Res. 2026 May 17:ntag110. doi: 10.1093/ntr/ntag110. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2019
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Smoking cessation; Serious mental illness
• Additional Relevant MeSH Terms: Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Smoking; Health Behavior; Tobacco Use; Tobacco Use Disorder; Mental Disorders; Smoking Cessation; Tobacco Smoking; Organic Chemicals; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Behavioral Disciplines and Activities; Mental Health Services; Ketones; Propiophenones; Bupropion; Counseling
• Other Study ID Numbers: T29IP0235; 22637 (Other Identifier: University of California, San Francisco); NCI-2022-02281 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No