Smoking CessationPhase 4PARQuitNCT03950427
PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness
A Phase 4 study testing Videogame-based physical activity, Sedentary videogame and Bupropion in people with Smoking Cessation and Smoking, Tobacco, run by University of California, San Francisco at 1 site in United States.
Trial 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), Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Smoking, Tobacco, Mental Illness
- What is being tested?
- Videogame-based physical activity, Sedentary videogame and Bupropion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2019to 30 Jul 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143-0610
About this study
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),
Read the 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.
- Being tested
- Videogame-based physical activity, Sedentary videogame, Bupropion, Counseling
- Keywords
- Smoking cessation, Serious mental illness
- Medical subject headings
- Smoking Cessation, Tobacco Smoking, Mental Disorders, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videogame-based physical activityBehavioural
videogame-based physical activity
Sedentary videogameBehavioural
sedentary videogame
BupropionDrug
Also called Wellbutrin, Zyban
Bupropion
CounselingBehavioural
Counseling for smoking cessation
| Study group | Role | What they receive |
|---|---|---|
| Game-based Physical Activity Group | Active comparator | 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. Receives: Behavioral: Videogame-based physical activity; Drug: Bupropion; Behavioral: Counseling |
| Sedentary Videogame Group | Placebo comparator | 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. Receives: Behavioral: Sedentary videogame; Drug: Bupropion; Behavioral: Counseling |
| CLOSED - Videogame-based Physical (VIP) Active Group, Pre-COVID | Active comparator | 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. Receives: Behavioral: Videogame-based physical activity; Drug: Bupropion; Behavioral: Counseling |
| CLOSED - VIP Sedentary Group, Pre-COVID | Placebo comparator | 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. Receives: Behavioral: Sedentary videogame; Drug: Bupropion; Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At week 12
Point-prevalent Abstinence (PPA)
Number of participants reporting not using tobacco at week 12
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start8 Jul 2019
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a pilot, randomized controlled trial (RCT) to examine the feasibility and potential efficacy of an application of a videogame-based group physical activity intervention for smoking cessation in adults with SMI.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Responsible party
- Sponsor
- Investigators
- Heather Leutwyler, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950427
- Sponsor's protocol ID
- T29IP0235
- Other IDs
- 22637, NCI-2022-02281
- Acronym
- PARQuit
- Status last verified
- Jul 2026
- First submitted
- 13 May 2019
- Last updated
- 17 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 42143578
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT03950427
- Acronym / sponsor ID
- PARQuit / T29IP0235
- Keywords
- Smoking cessation, Serious mental illness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Posted 17 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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),
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study is a pilot, randomized controlled trial (RCT) to examine the feasibility and potential efficacy of an application of a videogame-based group physical activity intervention for smoking cessation in adults with SMI.
| Arm | Type | Receives |
|---|---|---|
| Game-based Physical Activity Group | Active comparator | Behavioral: Videogame-based physical activity, Drug: Bupropion, Behavioral: CounselingThe 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. |
| Sedentary Videogame Group | Placebo comparator | Behavioral: Sedentary videogame, Drug: Bupropion, Behavioral: CounselingThe 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. |
| CLOSED - Videogame-based Physical (VIP) Active Group, Pre-COVID | Active comparator | Behavioral: Videogame-based physical activity, Drug: Bupropion, Behavioral: CounselingThe 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. |
| CLOSED - VIP Sedentary Group, Pre-COVID | Placebo comparator | Behavioral: Sedentary videogame, Drug: Bupropion, Behavioral: CounselingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Videogame-based physical activityvideogame-based physical activity | Behavioural | CLOSED - Videogame-based Physical (VIP) Active Group, Pre-COVID, Game-based Physical Activity Group |
| Sedentary videogamesedentary videogame | Behavioural | CLOSED - VIP Sedentary Group, Pre-COVID, Sedentary Videogame Group |
| BupropionAlso: Wellbutrin, ZybanBupropion | Drug | CLOSED - VIP Sedentary Group, Pre-COVID, CLOSED - Videogame-based Physical (VIP) Active Group, Pre-COVID, Game-based Physical Activity Group, Sedentary Videogame Group |
| CounselingCounseling for smoking cessation | Behavioural | CLOSED - VIP Sedentary Group, Pre-COVID, CLOSED - Videogame-based Physical (VIP) Active Group, Pre-COVID, Game-based Physical Activity Group, Sedentary Videogame Group |
Primary outcome
Total Number of Videogame Sessions Attended
Time frame: Up to 12 weeks
Feasibility will be measured with a total count of sessions attended. The graduate student researcher (GSR) will document participant attendance.
Total Minutes of Videogame Sessions Attended
Time frame: Up to 12 weeks
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.
Mean Score on a Self-report Acceptability Question at Week 6
Time frame: 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.
Mean Score on a Self-report Acceptability Question at Week 12
Time frame: 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.
Mean Number of Cigarettes Smoked by Group at Week 6
Time frame: 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.
Mean Number of Cigarettes Smoked by Group at Week 12
Time frame: 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.
Point-prevalent Abstinence (PPA)
Time frame: At week 12
Number of participants reporting not using tobacco at week 12
Mean Scores at Baseline on the Brief Psychiatric Rating Scale (BPRS)
Time frame: At Baseline (1 day)
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.
Mean Scores at Week-6 on the Brief Psychiatric Rating Scale (BPRS)
Time frame: At week 6
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.
Mean Scores at Week-12 on the Brief Psychiatric Rating Scale (BPRS)
Time frame: At week 12
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42143578Whitmore 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Leutwyler, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Videogame-based physical activity, Sedentary videogame and Bupropion in people with Smoking Cessation and Smoking, Tobacco, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Videogame Sessions Attended (time frame: Up to 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03950427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.