500 Participants Needed
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Extended Bupropion Treatment for Smoking Cessation

((KISV) Trial)

Recruiting in Kansas City (>99 mi)
TS
Overseen ByTricia Snow, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will evaluate the efficacy of extended bupropion(6 months) versus standard bupropion treatment (7 weeks) among African American daily smokers.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications, especially psychoactive medications and specific drugs metabolized by the liver enzyme CYP2D6, like metoprolol and tamoxifen. You also need to avoid using stop smoking medications in the 30 days before joining the study.

Is bupropion safe for smoking cessation?

Bupropion, used for smoking cessation, has been associated with minimal side effects in trials, but there are reports of adverse reactions and a warning about potential suicidal behavior and depression. Most exposures to bupropion were unintentional, with some serious effects noted, especially in cases of overdose.12345

How is the drug bupropion unique for smoking cessation?

Bupropion is unique for smoking cessation because it is one of the first non-nicotine medications used for this purpose, and it works by affecting brain chemicals related to addiction. It is often used in combination with cognitive-behavioral therapy (CBT) to improve success rates, and it has been shown to have minimal side effects compared to other treatments.36789

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

Research shows that Bupropion helps people quit smoking better than nicotine patches and increases success rates in quitting smoking. It has been effective in various studies, including those involving healthcare professionals.37101112

Who Is on the Research Team?

LS

Lisa Sanderson Cox, PhD

Principal Investigator

University of Kanas Medical Center

Are You a Good Fit for This Trial?

This trial is for African American adults who smoke daily, want to quit, and are willing to commit to a 6-month treatment plan. Participants must not be using any stop smoking medications recently, be pregnant or breastfeeding, have had a recent heart attack, or take certain drugs metabolized by the liver enzyme CYP2D6.

Inclusion Criteria

African American
Smoked on >25 days in the past month
I want to quit smoking.
See 4 more

Exclusion Criteria

Other smoker in household enrolled in the study
Reported use of opiates, cocaine, or stimulants
Breastfeeding
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bupropion treatment with culturally-relevant smoking cessation counseling

7 weeks for standard treatment, 24 weeks for extended treatment
8 counseling sessions

Follow-up

Participants are monitored for smoking abstinence and medication adherence

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Bupropion
Trial Overview The study compares two durations of bupropion treatment for quitting smoking: an extended course of 6 months versus the standard duration of 7 weeks. It aims to determine which is more effective in helping African American smokers achieve abstinence.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Standard TreatmentActive Control1 Intervention
Group II: Extended TreatmentActive Control1 Intervention

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

🇺🇸
Approved in United States as Wellbutrin for:
🇪🇺
Approved in European Union as Wellbutrin for:
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Approved in Canada as Zyban for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials
527
Recruited
181,000+

Published Research Related to This Trial

In a study involving 1071 smokers, bupropion and nicotine replacement therapy (NRT) showed similar effectiveness for smoking cessation, with abstinence rates of 27.9% for bupropion and 24.2% for NRT, indicating no significant difference between the two treatments.
Bupropion may be particularly beneficial for smokers with a history of depression, as those individuals had a higher abstinence rate (29.8%) compared to those using NRT (18.5%), suggesting that treatment choice may be tailored based on mental health history.
Randomized trial of nicotine replacement therapy (NRT), bupropion and NRT plus bupropion for smoking cessation: effectiveness in clinical practice.Stapleton, J., West, R., Hajek, P., et al.[2022]
In a study involving 707 smokers, bupropion sustained release (SR) combined with counseling significantly increased smoking cessation rates, with a continuous abstinence rate of 46% compared to 23% for placebo during weeks 4 to 7.
At the 12-month mark, the continuous abstinence rate was 21% for the bupropion SR group versus 11% for placebo, indicating long-term effectiveness, although some participants experienced higher rates of side effects like insomnia and dry mouth.
A multicentre, randomized, double-blind, placebo-controlled, 1-year study of bupropion SR for smoking cessation.Tønnesen, P., Tonstad, S., Hjalmarson, A., et al.[2019]
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.
Bupropion SR vs placebo for smoking cessation in health care professionals.Zellweger, JP., Boelcskei, PL., Carrozzi, L., et al.[2019]

Citations

Randomized trial of nicotine replacement therapy (NRT), bupropion and NRT plus bupropion for smoking cessation: effectiveness in clinical practice. [2022]
A multicentre, randomized, double-blind, placebo-controlled, 1-year study of bupropion SR for smoking cessation. [2019]
Bupropion SR vs placebo for smoking cessation in health care professionals. [2019]
Suitability of bupropion SR for nicotine-dependent smokers: problems in a practice setting. [2017]
Evaluation of the safety of bupropion (Zyban) for smoking cessation from experience gained in general practice use in England in 2000. [2023]
Suicidal behavior and depression in smoking cessation treatments. [2022]
Bupropion exposures: clinical manifestations and medical outcome. [2019]
Use of varenicline versus bupropion and risk of psychiatric adverse events. [2022]
Trends in utilization of smoking cessation agents before and after the passage of FDA boxed warning in the United States. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Using extended cognitive behavioral treatment and medication to treat dependent smokers. [2021]
Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Effectiveness of bupropion sustained release for smoking cessation in a health care setting: a randomized trial. [2023]
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