Smoking Cessation Program for Tobacco Use Disorder

(PARQuit Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Heather Leutwyler, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of California, San Francisco

Must not be taking: MAO inhibitors

Disqualifiers: Pregnancy, Seizure disorder, Angina, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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),

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 data supports the effectiveness of the drug Bupropion for smoking cessation?

Research shows that Bupropion SR can help people quit smoking, with studies indicating it increases the chances of quitting compared to a placebo. However, its effectiveness may vary, and there are concerns about its safety for some users. ^{1 2 3 4 5}

Is the smoking cessation treatment safe for humans?

Bupropion, used for smoking cessation, is generally safe for humans, but it carries a small risk of seizures (about 0.1%) and should not be used by people with a history of seizures. Other side effects can include dry mouth and insomnia, and allergic reactions occur in about 3% of users. Serious side effects are rare when used according to guidelines. ^{1 5 6 7 8}

How is this smoking cessation treatment different from others?

This treatment is unique because it combines bupropion, a non-nicotine medication that reduces cravings, with counseling and a novel videogame-based physical activity, offering a comprehensive approach to quitting smoking. ^{5 6 7 9 10}

Research Team

Heather Leutwyler, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Bupropion (Antidepressant)
• Counseling (Behavioral Intervention)
• Sedentary videogame (Behavioral Intervention)
• Videogame-based physical activity (Behavioral Intervention)

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.

Participant Groups

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 Canada for the following indications:

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+

Suresh Gunasekaran

University of California, San Francisco

Chief Executive Officer since 2022

MBA from Southern Methodist University

Dr. Lukejohn Day

University of California, San Francisco

Chief Medical Officer

MD from Stanford University School of Medicine

Tobacco Related Disease Research Program

Collaborator

Trials

27

Recruited

26,300+

Findings from Research

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]

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]

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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Suitability of bupropion SR for nicotine-dependent smokers: problems in a practice setting. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Body image treatment for weight concerned smokers: a pilot study. [2018]

3. England pubmed.ncbi.nlm.nih.gov

A randomized controlled clinical trial of bupropion SR and individual smoking cessation counseling. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Smoking cessation treatment in a real-life setting: the Greek experience. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Bupropion and the risk of sudden death: a self-controlled case-series analysis using The Health Improvement Network. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

Review of bupropion for smoking cessation. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of bupropion sustained release for smoking cessation in a health care setting: a randomized trial. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

[Uneasiness about the safety of bupropion as an aid to smoking cessation unjustified ]. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Bupropion SR vs placebo for smoking cessation in health care professionals. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Bupropion for smoking cessation: a review. [2019]