PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness

NCT ID: NCT03950427

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-08
• Study Completion Date: 2025-07-30

Brief Summary

This is a research study about 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),

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.

Conditions

Smoking Cessation; Smoking, Tobacco; Mental Illness; Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Videogame-based physical activity

Intervention Type: BEHAVIORAL

videogame-based physical activity

Bupropion

Intervention Type: DRUG

Bupropion

Counseling

Intervention Type: BEHAVIORAL

Counseling for smoking cessation

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.

Group Type: PLACEBO_COMPARATOR

Sedentary videogame

Intervention Type: BEHAVIORAL

sedentary videogame

Bupropion

Intervention Type: DRUG

Bupropion

Counseling

Intervention Type: BEHAVIORAL

Counseling for smoking cessation

Interventions

Videogame-based physical activity

videogame-based physical activity

Intervention Type: BEHAVIORAL

Sedentary videogame

sedentary videogame

Intervention Type: BEHAVIORAL

Bupropion

Bupropion

Intervention Type: DRUG

Counseling

Counseling for smoking cessation

Intervention Type: BEHAVIORAL

Other Intervention Names

Wellbutrin; Zyban

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tobacco Related Disease Research Program

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather Leutwyler, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

22637

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2022-02281

Identifier Type: REGISTRY

Identifier Source: secondary_id

T29IP0235

Identifier Type: -

Identifier Source: org_study_id