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

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),

Study Overview

• Status: Recruiting
• 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 (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Heather Leutwyler, PhD; Phone Number: 415-514-1524; Email: Heather.Leutwyler@ucsf.edu
• Study Contact Backup: Name: Erin Hubbard, MPH; Phone Number: 415-502-7774; Email: erin.hubbard@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143-0610
      • Recruiting
      • University of California, San Francisco
      • Contact: Heather Leutwyler, PhD; Phone Number: 415-514-1524; Email: Heather.Leutwyler@ucsf.edu

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 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

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.	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.	12-weeks
Week-6 Self-report acceptability rankings of the videogames	This internally developed acceptability questionnaire has 7 questions. Three questions use a 1 to 5 scale with 1 indicating least acceptable and 5 indicating most acceptable, for a possible total range of 3-15. The remaining open-ended questions are scored using qualitative thematic analysis.	administered at week 6
Week-12 Self-report acceptability rankings of the videogames -week 12	This internally developed acceptability questionnaire has 7 questions. Three questions use a 1 to 5 scale with 1 indicating least acceptable and 5 indicating most acceptable, for a possible total range of 3-15. The remaining open-ended questions are scored using qualitative thematic analysis. Used to measure change from week-6 to week-12.	administered at week 12.
Tobacco reduction and abstinence	The investigators will ask about the number of cigarettes, 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.	administered at week 6.
Tobacco reduction and abstinence	The investigators will ask about the number of cigarettes, 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.	administered at week 12.
Baseline 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. The score will be used to measure change between the baseline, 6-week, and 12-week time points.	Baseline interview with the participant and observations of the participant's behavior over the previous 2-3 days.
Week-6 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. The score will be used to measure change between the baseline, 6-week, and 12-week time points.	interview at week-6 with the participant and observations of the participant's behavior over the previous 2-3 days.
Week-12 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. The score will be used to measure change between the baseline, 6-week, and 12-week time points.	interview at week-12 with the participant and observations of the participant's behavior over the previous 2-3 days.

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

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2019
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 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): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: smoking cessation; serious mental illness
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Substance-Related Disorders; Mental Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• 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