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Antidepressant
Smoking Cessation Program for Tobacco Use Disorder (PARQuit Trial)
Phase 4
Recruiting
Led By Heather Leutwyler, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up interview at week-12 with the participant and observations of the participant's behavior over the previous 2-3 days.
Awards & highlights
PARQuit Trial Summary
This trial is testing a new smoking cessation program that uses a videogame, physical activity, and counseling for adults with mental illness.
Who is the study for?
Adults with serious mental illness who smoke at least five cigarettes daily for the past six months, are willing to quit, and can consent. They must not be pregnant or breastfeeding, taking certain medications like MAO inhibitors or bupropion, have a history of seizures or eating disorders, or conditions that limit exercise.Check my eligibility
What is being tested?
The trial is testing a smoking cessation program using videogame-based physical activities alongside counseling and bupropion medication. Participants will engage in this tailored program while continuing their treatment at Progress Foundation programs.See study design
What are the potential side effects?
Bupropion may cause side effects such as dry mouth, trouble sleeping, headache, nausea, and increased risk of seizures. The videogame-based activity could lead to typical exercise-related issues if participants have underlying health problems.
PARQuit Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not using bupropion or any nicotine replacement therapies.
Select...
I am currently in a Progress Foundation treatment program and plan to stay for at least 12 weeks.
Select...
I am able to understand and agree to the study's requirements.
Select...
I am 18 years old or older.
PARQuit Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ interview at week-12 with the participant and observations of the participant's behavior over the previous 2-3 days.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~interview at week-12 with the participant and observations of the participant's behavior over the previous 2-3 days.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Baseline Brief Psychiatric Rating Scale (BPRS)
Tobacco reduction and abstinence
Total minutes of videogame sessions attended
+5 morePARQuit Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: game-based Physical Activity GroupActive Control3 Interventions
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 II: Sedentary Videogame GroupPlacebo Group3 Interventions
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.
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,435 Total Patients Enrolled
31 Trials studying Tobacco Use Disorder
7,427 Patients Enrolled for Tobacco Use Disorder
Tobacco Related Disease Research ProgramOTHER
25 Previous Clinical Trials
20,498 Total Patients Enrolled
7 Trials studying Tobacco Use Disorder
889 Patients Enrolled for Tobacco Use Disorder
Heather Leutwyler, PhDPrincipal InvestigatorUniversity of California, San Francisco
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been smoking at least five cigarettes every day for the past six months.I am not using bupropion or any nicotine replacement therapies.You have already participated in the video game-based physical activity program in the past.You have been diagnosed with a serious mental illness (SMI).I have a condition that increases my risk of seizures.I am currently in a Progress Foundation treatment program and plan to stay for at least 12 weeks.I am able to understand and agree to the study's requirements.I am 18 years old or older.I am not using MAO inhibitors and haven't used them in the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: Sedentary Videogame Group
- Group 2: game-based Physical Activity Group
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been accepted for this research project?
"Affirmative. Clinicaltrials.gov confirms that the study is currently enrolling participants, which was initially posted on July 8th of 2019 and updated most recently August 9th 2022. The trial requires 120 enrollees at 1 medical centre to complete their protocol."
Answered by AI
Is the Physical Activity Group, that utilizes gaming technology, sanctioned by the FDA?
"The safety rating of the game-based Physical Activity Group is assessed as a 3, which suggests that this phase 4 trial has been approved."
Answered by AI
What advantages does the Game-Based Physical Activity Group offer individuals?
"Using an entertaining game-based physical activity approach, Seasonal Affective Disorder, smoking cessation and smoke exposure can all be effectively managed."
Answered by AI
Are there any opportunities for people to get involved in this experiment?
"According to clinicaltrials.gov, the trial is still open for recruitment and was last amended on August 9th 2022 after its initial posting date of July 8th 2019."
Answered by AI
Have any prior investigations investigated the effects of game-based Physical Activity Group?
"Presently, 31 clinical trials investigating the effects of game-based physical activity are taking place with 10 studies in their final stage. Most experiments for this topic can be found in New Haven, Connecticut; however, a total of 283 sites are conducting research related to this area."
Answered by AI
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