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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

Must not have

Use of Monoamine oxidase (MAO) inhibitors (concurrently or within 14 days of discontinuing either bupropion or the MAO inhibitor)

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

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Drug Has Already Been Approved

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not using bupropion or any nicotine replacement therapies.

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I am currently in a Progress Foundation treatment program and plan to stay for at least 12 weeks.

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I am able to understand and agree to the study's requirements.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not using MAO inhibitors and haven't used them in the last 14 days.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and interview at week-12 with the participant and observations of the participant's behavior over the previous 2-3 days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Baseline Brief Psychiatric Rating Scale (BPRS)

Tobacco reduction and abstinence

Total minutes of videogame sessions attended

+5 more

Awards & Highlights

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.

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.

0 / 5Eligibility criteria met