Extended Bupropion Treatment for Smoking Cessation
((KISV) Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: University of Kansas Medical Center
Must not be taking: Psychoactive, Opiates, Cocaine, Stimulants
Disqualifiers: Substance abuse, Seizures, Pregnancy, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
56789How 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.
25101112Eligibility Criteria
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.
+4 more
Exclusion Criteria
Other smoker in household enrolled in the study
Reported use of opiates, cocaine, or stimulants
Breastfeeding
+11 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Active Control
Group I: Standard TreatmentActive Control1 Intervention
250 participants will be randomly assigned to the standard treatment arm and receive 7 weeks of bupropion SR following standard dosing guidelines(150 mg once daily for 3 days, then 150mg twice daily for 7 weeks). Participants in this arm will also receive 8 smoking cessation counseling sessions consistent with the Clinical Practice Guidelines.
Group II: Extended TreatmentActive Control1 Intervention
250 participants will be randomly assigned to the extended treatment arm and receive 24 weeks of bupropion SR following standard dosing guidelines(150 mg once daily for 3 days, then 150mg twice daily for 24 weeks). Participants in this arm will also receive 8 smoking cessation counseling sessions consistent with the Clinical Practice Guidelines.
Bupropion is already approved in United States, European Union, Canada, Australia 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
🇦🇺 Approved in Australia as Wellbutrin for:
- Major depressive disorder
- Seasonal affective disorder
- Smoking cessation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Kansas Medical CenterKansas City, MO
Loading ...
Who Is Running the Clinical Trial?
University of Kansas Medical CenterLead Sponsor
References
Randomized trial of nicotine replacement therapy (NRT), bupropion and NRT plus bupropion for smoking cessation: effectiveness in clinical practice. [2022]Bupropion was introduced for smoking cessation following a pivotal trial showing that it gave improved efficacy over the nicotine patch and also suggesting combination treatment was beneficial. We tested in clinical practice for an effectiveness difference between bupropion and nicotine replacement therapy (NRT), whether the combination improves effectiveness and whether either treatment might be more beneficial for certain subgroups of smokers.
A multicentre, randomized, double-blind, placebo-controlled, 1-year study of bupropion SR for smoking cessation. [2019]Bupropion sustained release (bupropion SR) has been shown to increase smoking cessation success rates in the US studies.
Bupropion SR vs placebo for smoking cessation in health care professionals. [2019]To evaluate bupropion SR for smoking cessation in physicians and nurses.
Suitability of bupropion SR for nicotine-dependent smokers: problems in a practice setting. [2017]Bupropion SR (Zyban) has been shown in randomized controlled trials to be an efficacious pharmacological aid for smoking cessation; however, recent reports have raised serious concerns about the breadth of its applicability without complications or contraindications.
Evaluation of the safety of bupropion (Zyban) for smoking cessation from experience gained in general practice use in England in 2000. [2023]Bupropion (Zyban) is the first new pharmacological treatment for smoking cessation to be introduced since nicotine replacement therapy. In smoking cessation trials, it has been associated with minimal side effects. A range of suspected adverse drug reactions (ADRs) were reported via the spontaneous reporting system following its use in smoking cessation.
Suicidal behavior and depression in smoking cessation treatments. [2022]Two treatments for smoking cessation--varenicline and bupropion--carry Boxed Warnings from the U.S. Food and Drug Administration (FDA) about suicidal/self-injurious behavior and depression. However, some epidemiological studies report an increased risk in smoking or smoking cessation independent of treatment, and differences between drugs are unknown.
Bupropion exposures: clinical manifestations and medical outcome. [2019]Bupropion is an antidepressant and smoking cessation aid. Limited toxicological information exists for intentional and unintentional bupropion-only exposures. A retrospective review of all bupropion-only exposures reported to the Toxic Exposure Surveillance System from 1998 through 1999 was conducted. Data for the three bupropion products, Wellbutrin, Wellbutrin SR, and Zyban, included demographics, reason for exposure, clinical effects, therapy, and medical outcome. A total of 7,348 bupropion-only exposures were reported: 56% female and 61% unintentional. The majority of exposures involved Wellbutrin SR; however, Wellbutrin exposures involved a higher percentage of intentional overdoses and serious clinical effects. Clinical effects related to bupropion were noted in 2,247 (31%) exposures; 8% of all children
Use of varenicline versus bupropion and risk of psychiatric adverse events. [2022]To investigate whether varenicline use was associated with increased risk of psychiatric adverse events, compared with bupropion, another drug used for smoking cessation.
Trends in utilization of smoking cessation agents before and after the passage of FDA boxed warning in the United States. [2018]In 2009, the FDA required a black box warning (BBW) on bupropion and varenicline, the two commonly prescribed smoking cessation agents due to reports of adverse neuropsychiatric events. We investigated if there was a decline in use of bupropion and varenicline after the BBW by comparing the percent using these medications before and after BBW.
Using extended cognitive behavioral treatment and medication to treat dependent smokers. [2021]We evaluated smoking-cessation efficacy of an extended course of sustained-release bupropion (bupropion SR) and cognitive-behavioral treatment (CBT).
Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. [2022]Varenicline, a new treatment for smoking cessation, has demonstrated significantly greater efficacy over placebo and sustained release bupropion (bupropion SR). A study was undertaken to compare a 12-week standard regimen of varenicline with a 10-week standard regimen of transdermal nicotine replacement therapy (NRT) for smoking cessation.
Effectiveness of bupropion sustained release for smoking cessation in a health care setting: a randomized trial. [2023]The efficacy of bupropion hydrochloride sustained release (SR) (Zyban) for smoking cessation has been evaluated in clinical trials that included frequent in-person behavioral counseling, but not in actual practice settings.