Smoking Cessation Program for Tobacco Use Disorder

(PARQuit Trial)

Overseen By Erin Hubbard, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Must not be taking: MAO inhibitors

Disqualifiers: Pregnancy, Seizure disorder, Angina, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help adults with serious mental illness quit smoking by testing a new program that includes active video games, counseling, and bupropion, an antidepressant also used for smoking cessation. Participants will be divided into two groups: one will play games using body movement sensors, while the other will play seated games. The trial targets individuals who smoke at least five cigarettes a day, have a serious mental illness such as schizophrenia or bipolar disorder, and are willing to attempt quitting smoking. As a Phase 4 trial, this research explores the benefits of an already FDA-approved and effective treatment to assist more patients in quitting smoking.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on bupropion or nicotine replacement therapy to participate. If you are using Monoamine oxidase (MAO) inhibitors, you must stop them at least 14 days before starting bupropion.

What is the safety track record for these treatments?

A previous study found bupropion to be a generally safe and effective option for helping people quit smoking. However, individuals with existing mental health conditions should be aware of potential mental health side effects and discuss these with a healthcare provider.

Counseling for quitting smoking has proven safe and can significantly aid individuals in stopping smoking. Whether conducted in groups or one-on-one, counseling supports individuals through their quitting journey without major safety concerns.

Research indicates that video game-based physical activities are safe and can increase motivation and engagement in quitting smoking. These activities might even improve the chances of successfully stopping smoking by making the process more enjoyable.

Overall, the treatments in this trial have demonstrated safety for people trying to quit smoking. Consulting with a healthcare provider for personalized advice is always advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores how combining physical activity with gaming can enhance smoking cessation efforts. Unlike typical treatments that focus on medication and counseling alone, this trial incorporates active video games using the Kinect for Xbox 360, potentially making quitting smoking more engaging and enjoyable. This approach may increase motivation and adherence to the cessation program, offering a novel method to support individuals in overcoming tobacco use disorder.

What evidence suggests that this trial's treatments could be effective for tobacco use disorder?

Research shows that bupropion, which participants in this trial will receive, can help people quit smoking. One study found that 27% of people taking bupropion quit smoking within 26 weeks, compared to only 11% of those not taking it. Another study discovered that combining bupropion with nicotine patches or gum increased the quit rate by 20%. Participants in this trial will also receive counseling for smoking cessation. Additionally, the trial includes a Game-based Physical Activity Group. Research suggests that using games to encourage physical activity can help people stop smoking in the short term. Overall, these treatments appear promising for helping people quit smoking. ^{1 6 7 8 9}

Who Is on the Research Team?

Heather Leutwyler, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion 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 been diagnosed with a serious mental illness (SMI).

Exclusion Criteria

Currently pregnant or breastfeeding

You have already participated in the video game-based physical activity program in the past.

I have a condition that increases my risk of seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive counseling, medication (bupropion or NRT), and participate in either a sedentary or active videogame group for smoking cessation

12 weeks

3 assessment visits (2 hours each), 8 counseling sessions (30 minutes each), 36 videogame sessions (1 hour each)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bupropion
• Counseling
• Sedentary videogame
• Videogame-based physical activity

Trial Overview 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.

How Is the Trial Designed?

Group I: Game-based Physical Activity Group Active Control 3 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 Group Placebo Group 3 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.

Bupropion is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Wellbutrin for:

• Major depressive disorder
• Seasonal affective disorder
• Smoking cessation

Approved in European Union as Wellbutrin for:

• Major depressive disorder
• Seasonal affective disorder
• Smoking cessation

Approved in Canada as Zyban for:

• Smoking cessation

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Tobacco Related Disease Research Program

Collaborator

Trials

27

Recruited

26,300+

Published Research Related to This Trial

Bupropion SR significantly increased smoking abstinence rates compared to placebo, with odds ratios indicating nearly double the likelihood of quitting at the end of treatment.

Individual counseling did not enhance the effectiveness of bupropion SR or contribute to higher abstinence rates, suggesting that medication alone may be sufficient for smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled clinical trial of bupropion SR and individual smoking cessation counseling. McCarthy, DE., Piasecki, TM., Lawrence, DL., et al.[2022]

In a study of 895 smokers, those treated with bupropion SR combined with behavioral therapy achieved post-treatment abstinence rates of up to 71.6%, indicating that this combination is highly effective for smoking cessation.

Long-term follow-up showed that predictors for sustained abstinence after one year included the use of bupropion SR, lower nicotine addiction, and the smoker's motivation, highlighting the importance of both medication and personal commitment in achieving lasting results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation treatment in a real-life setting: the Greek experience. Rovina, N., Nikoloutsou, I., Dima, E., et al.[2015]

In a study involving 78 veterans participating in a smoking cessation program, only 22% were deemed appropriate candidates for bupropion SR (Zyban) treatment, indicating limited applicability in this population.

The findings suggest that while bupropion SR is effective for smoking cessation, its use may be restricted by conservative prescribing guidelines, raising concerns about its broader applicability without complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suitability of bupropion SR for nicotine-dependent smokers: problems in a practice setting. Kohlenberg, BS., Antonuccio, DO., Hayes, SC., et al.[2017]

Bupropion hydrochloride (Zyban) is an effective non-nicotine medication for smoking cessation, showing positive outcomes across various populations, including those with depression and chronic diseases, based on a review of over 4,000 subjects.

While bupropion is generally safe with rare serious side effects, the main concern is a low risk of seizures (about 0.1%), making it unsuitable for individuals with a history of seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of bupropion for smoking cessation. Richmond, R., Zwar, N.[2013]

Bupropion, an anti-smoking drug, is considered effective and safe when used according to guidelines, but reports of 41 deaths linked to its use highlight the importance of adhering to safety protocols, especially in patients at risk for seizures.

The majority of adverse reactions involved patients combining bupropion with other medications that increase seizure risk, indicating that proper prescribing practices are crucial for minimizing risks and ensuring the drug's efficacy in smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Uneasiness about the safety of bupropion as an aid to smoking cessation unjustified ]. Wagena, EJ., de Graaf, L., Chavannes, NH., et al.[2017]

In a study of 9329 patients prescribed bupropion, there was no evidence of an increased risk of sudden death during the first 28 days of treatment, with only 2 deaths occurring in this period, which is lower than expected.

Bupropion is associated with an increased risk of seizures, with a relative incidence of 3.62 during the first 28 days, translating to one additional seizure per 6219 first-time users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupropion and the risk of sudden death: a self-controlled case-series analysis using The Health Improvement Network. Hubbard, R., Lewis, S., West, J., et al.[2022]

In a study involving 1524 adult smokers, bupropion SR (300 mg) combined with behavioral counseling showed a significantly higher rate of nonsmoking at 3 months compared to the lower dose (150 mg), indicating that higher doses may enhance smoking cessation efforts.

At 12 months, participants receiving moderate intensity counseling had a significantly higher rate of nonsmoking, suggesting that the intensity of behavioral support plays a crucial role in the effectiveness of smoking cessation interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of bupropion sustained release for smoking cessation in a health care setting: a randomized trial. Swan, GE., McAfee, T., Curry, SJ., et al.[2023]

In a study involving 687 physicians and nurses, bupropion SR was found to be more effective than placebo for smoking cessation, with a 50% success rate compared to 40% for the placebo group after 4 weeks.

Although bupropion SR was effective during treatment, the high placebo response in this population meant that the differences in success rates did not persist after treatment ended, highlighting the need for additional relapse prevention strategies for long-term abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupropion SR vs placebo for smoking cessation in health care professionals. Zellweger, JP., Boelcskei, PL., Carrozzi, L., et al.[2019]

Bupropion is recognized as the only antidepressant recommended as a first-line treatment for helping people quit smoking, highlighting its importance in smoking cessation efforts.

It has been shown to be as effective as nicotine replacement therapy and is suitable for use in a variety of populations, making it a versatile option for those looking to stop smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupropion for smoking cessation: a review. Tong, EK., Carmody, TP., Simon, JA.[2019]

In a pilot study involving 41 female smokers concerned about their weight, those receiving cognitive behavioral therapy focused on body image had a slightly higher smoking abstinence rate (35%) compared to those focused on weight management (24%) after 12 weeks, although this difference was not statistically significant (p=0.505).

All participants also received bupropion SR, exercise instruction, and weekly counseling for smoking cessation, indicating that the combination of these interventions may support smoking cessation efforts, regardless of the therapy focus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body image treatment for weight concerned smokers: a pilot study. Clark, MM., Hays, JT., Vickers, KS., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2528204/

The use of bupropion SR in cigarette smoking cessation In patients with established CVD, bupropion has similar success rates compared with healthy smokers (27% bupropion vs 11% placebo at 26 weeks, 22% vs 9% at 52 ...

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/217331

Bupropion for Smoking Cessation: A Randomized Trial One of these clinical studies reported an absolute 20% increase in 1-year quit rates among participants receiving combined bupropion plus NRT compared with ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00129272

Effectiveness of Bupropion for Treating Nicotine ... Bupropion (a medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The purpose of this study is to determine if bupropion is ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871622000497

Evaluating the effectiveness of bupropion and varenicline ... Varenicline was more effective than bupropion for quitting at end of treatment. Both medications were safe and well-tolerated throughout the treatment.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10211174/

Efficacy of bupropion for smoking cessation in smokers ... Results: A significant dose-response effect of bupropion for smoking cessation was found. This was independent of history of major depression or alcoholism.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK470212/

Bupropion - StatPearls - NCBI Bookshelf - NIH As a result, the FDA warning for bupropion for smoking cessation changed. However, the report notes that these reactions remain concerning, especially in ...

7. fda.gov fda.gov/media/101633/download

smoking medicines Chantix (varenicline) and Zyban ( ... The risk of these mental health side effects is still present, especially in those currently being treated for mental illnesses such as ...

8. cdc.gov cdc.gov/tobacco/campaign/tips/quit-smoking/quit-smoking-medications/how-to-use-quit-smoking-medicines/how-to-use-bupropion-sr.html

How to Use Bupropion SR | Quit Smoking All have been shown to be safe and effective for adults who smoke cigarettes. These quit-smoking medicines include nicotine replacement medicines (the nicotine ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/020711s052lbl.pdf

Zyban - accessdata.fda.gov In these trials, ZYBAN was used in conjunction with individual smoking cessation counseling. ... General information about the safe and effective use of ZYBAN.