Zonisamide + Bupropion for Smoking Cessation
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Rose Research Center, LLC
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This three-group randomized double-blind placebo-controlled trial (N=180) will evaluate the impact of combination zonisamide and bupropion on the process of switching from combustible cigarettes (CCs) to an e-cigarette. There will be a data collection period of at least five days to obtain baseline information on the use of combustible cigarettes. All participants enrolled in the study will receive a JUUL e-cigarette at Visit 2 for ad libitum use. After the first week of e-cigarette use (at Visit 3), participants will be given bupropion (150 mg each morning for days 1-3, then 300 mg daily) with either zonisamide (100 mg daily) or placebo (group 1 and group 2 respectively), or placebo for both medications (group 3) in addition to continued use of the e-cigarette. At each visit, participants will receive enough study drugs (or placebos) and e-cigarettes to last until their next study visit. The combination of zonisamide and bupropion use will continue until Visit 6 (7 weeks of treatment), and e-cigarette use will continue until the end of treatment (Visit 7).
Do I have to stop taking my current medications to join the trial?
Yes, you must stop taking antidepressants, psychoactive medications, or medications that prolong QTc to participate in the trial.
What data supports the idea that Zonisamide + Bupropion for Smoking Cessation is an effective drug?
The available research shows that bupropion, one of the components of the treatment, is effective for smoking cessation. It has been shown to reduce cravings and withdrawal symptoms, making it easier for people to quit smoking. Studies have demonstrated that bupropion is more effective than nicotine replacement therapy alone and is particularly helpful for people with conditions like depression or chronic obstructive pulmonary disease. However, there is no specific data provided on the combination of Zonisamide and Bupropion for smoking cessation.
12345What safety data is available for the use of Zonisamide and Bupropion in smoking cessation?
Bupropion, used for smoking cessation, has been evaluated for safety in various studies. Reports have linked it to adverse reactions, including seizures, especially when combined with other medications like antidepressants or in patients with seizure disorders. However, when used according to guidelines, it is considered safe and effective. Concerns about psychiatric adverse events, such as suicidal behavior and depression, have been noted, but these risks may be related to smoking cessation itself rather than the drug. A review of bupropion exposures showed that most cases were unintentional, with some serious effects in intentional overdoses. Overall, bupropion has been associated with minimal side effects in smoking cessation trials.
46789Is the drug Zonisamide + Bupropion a promising option for helping people quit smoking?
Yes, Bupropion is a promising drug for helping people quit smoking. It reduces cravings and withdrawal symptoms, making it easier for people to stop smoking. It has been shown to be effective in various studies and is especially helpful for people who have other health issues like depression or heart problems.
29101112Eligibility Criteria
This trial is for smokers aged 21-65 who smoke at least 10 cigarettes daily for the past year, want to switch to e-cigarettes, and can use a smartphone with text and data. Excluded are those with certain health issues like high blood pressure or heart disease, depression risks (PHQ-9 score >9), using other smoking cessation methods or psychoactive drugs, pregnant/nursing women, or anyone deemed unfit by medical staff.Inclusion Criteria
You want to start using an electronic cigarette.
I have been smoking at least 10 cigarettes daily for the past year.
Owns a smartphone with text message and data capabilities compatible with necessary surveys.
+4 more
Exclusion Criteria
Has a PHQ-9 score greater than 9, or a score greater than 0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") at screening.
Is unhealthy or cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) as judged by the Investigator or designated medical staff based on all available assessments from the screening period (e.g., safety laboratory, vital signs, physical examination, ECG, concomitant medications and medical history).
Has body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2.
+10 more
Participant Groups
The study tests if combining Zonisamide and Bupropion helps people switch from regular cigarettes to e-cigarettes. Participants will first use an e-cigarette alone then take either both drugs, one drug plus placebo, or double placebo alongside continued e-cigarette use over seven weeks in this three-group randomized double-blind trial.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Combination zonisamide and bupropion with e-cigaretteExperimental Treatment3 Interventions
After the first week of e-cigarette use (JUUL), participants will be given bupropion (150 mg each morning for days 1-3, then 300 mg daily) with zonisamide (100 mg daily). The combination of zonisamide and bupropion use will continue for 7 weeks of treatment, and e-cigarette use will continue until the end of the study (an additional 4 weeks).
Group II: Bupropion with e-cigaretteExperimental Treatment3 Interventions
After the first week of e-cigarette use (JUUL), participants will be given bupropion (150 mg each morning for days 1-3, then 300 mg daily) with placebo zonisamide. The combination of placebo and bupropion use will continue for 7 weeks of treatment, and e-cigarette use will continue until the end of the study (an additional 4 weeks).
Group III: Placebo with e-cigarettePlacebo Group3 Interventions
After the first week of e-cigarette use (JUUL), participants will be given placebo bupropion with placebo zonisamide. The combination of these placebos will continue for 7 weeks of treatment, and e-cigarette use will continue until the end of the study (an additional 4 weeks).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rose Research CenterCharlotte, NC
Rose Research CenterRaleigh, NC
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Who Is Running the Clinical Trial?
Rose Research Center, LLCLead Sponsor
Foundation for a Smoke-Free WorldCollaborator
Foundation for a Smoke Free World INCCollaborator
References
A real-life study of the effectiveness of different pharmacological approaches to the treatment of smoking cessation: re-discussing the predictors of success. [2022]To evaluate the effectiveness of nicotine replacement therapy (NRT), bupropion, nortriptyline and combination therapy and describe factors associated with treatment success.
Review of bupropion for smoking cessation. [2013]The advent of bupropion hydrochloride sustained release (Zyban) has heralded a major change in the options available for smoking cessation pharmacotherapy. Bupropion is a selective re-uptake inhibitor of dopamine and noradrenalin which prevents or reduces cravings and other features of nicotine withdrawal. Bupropion is a useful oral and non-nicotine form of pharmacotherapy for smoking cessation. For this review a total of 221 papers were reviewed plus poster presentations. This review examines in detail original clinical trials on efficacy, categorised according to whether they were acute treatment trials in healthy smokers; studies in specific populations such as people with depression, chronic obstructive pulmonary disease (COPD) or cardiovascular disease; or relapse prevention studies. Overall, these studies in varying populations comprising over four thousand subjects, showed bupropion consistently produces a positive effect on smoking cessation outcomes. The evidence highlights the major public health role that bupropion has in smoking cessation. The methodological issues of published clinical trials reporting one year outcomes were examined in detail including: completeness of follow-up; loss to follow-up; intention to treat analysis; blindness of assessment; and validation of smoking status. The review discusses contraindications, adverse effects, dose and overdose, addictive potential, and the role of bupropion in reducing cessation-related weight gain. Bupropion combined with or compared to other pharmacotherapies (nicotine patch; nortriptyline) is considered. Impressive evidence exists for the use of bupropion in smoking cessation among difficult patients who are hard-core smokers such as those with cardiovascular disease, chronic obstructive pulmonary disease (COPD) and depression. Bupropion reduces withdrawal symptoms as well as weight gain and is effective for smoking cessation for people with and without a history of depression or alcoholism. Serious side effects of bupropion use are rare. The major safety issue with bupropion is risk of seizures (estimated at approximately 0.1%) and it should not be prescribed to patients with a current seizure disorder or any history of seizures. In clinical trials of bupropion for smoking cessation no seizures were reported. Allergic reactions occur at a rate of approximately 3% and minor adverse effects are common including dry mouth and insomnia.
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.
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
A placebo-controlled trial of bupropion combined with nicotine patch for smoking cessation in schizophrenia. [2022]Individuals with schizophrenia smoke at higher rates (58%-88%) than the general population (approximately 22%), and have difficulty quitting. We determined whether the combination of sustained-release (SR) bupropion (BUP) with the transdermal nicotine patch (TNP) was well-tolerated and superior to placebo (PLO)+TNP for smoking cessation in schizophrenia.
[Uneasiness about the safety of bupropion as an aid to smoking cessation unjustified ]. [2017]A report in a national newspaper on Thursday 26 April 2001, linked the anti-smoking drug bupropion to 41 deaths. From the reports of suspected adverse reactions received by the Netherlands Pharmacovigilance Foundation, it appears that more than half the cases concerned patients at risk of developing smoking-related diseases. In 15 cases, the simultaneous use of bupropion and another antidepressant (10 patients), theophylline (1 patient) or insulin (4 patients) was reported, even though these combinations may lead to an increase in the risk of seizures. Furthermore, 2 patients were reported to have been taking anti-epileptics, despite the fact that use of bupropion is contra-indicated in patients with a seizure disorder. The results seem to illustrate that the guidelines described in the product information are not being adhered to in all cases. Provided that bupropion is used according to the guidelines in the product information, this new aid in smoking cessation is considered an effective and safe drug. It is highly unlikely that bupropion has contributed to any deaths. If prescribed appropriately and in combination with counselling (e.g. minimal intervention strategy), bupropion is as yet the most effective aid in helping people stop smoking.
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.
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.
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.
Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice. [2022]Strategies for assisting smoking cessation include behavioural counselling to enhance motivation and to support attempts to quit and pharmacological intervention to reduce nicotine reinforcement and withdrawal from nicotine. Three drugs are currently used as first line pharmacotherapy for smoking cessation, nicotine replacement therapy, bupropion and varenicline. Compared with placebo, the drug effect varies from 2.27 (95% CI 2.02, 2.55) for varenicline, 1.69 (95% CI 1.53, 1.85) for bupropion and 1.60 (95% CI 1.53, 1.68) for any form of nicotine replacement therapy. Despite some controversy regarding the safety of bupropion and varenicline, regulatory agencies consider these drugs as having a favourable benefit/risk profile. However, given the high rate of psychiatric comorbidity in dependent smokers, practitioners should closely monitor patients for neuropsychiatric symptoms. Second-line pharmacotherapies include nortriptyline and clonidine. This review also offers an overview of pipeline developments and issues related to smoking cessation in special populations such as persons with psychiatric comorbidity and pregnant and adolescent smokers.
[Acute psychotic disorders related to bupropion: review of the literature]. [2013]Bupropion, or amfebutamone, is an atypical antidepressant also used during tobacco cessation. From a structural standpoint, it resembles amphetamine drugs with psychostimulant effects, and endogenous monoamines. From a pharmacological standpoint, bupropion, and two of its most important active metabolites, inhibit dopamine and norepinephrine reuptake. It has recently been discovered that bupropion may act as a non-competitive cholinergic nicotinic receptor antagonist, and that it may inhibit the activation of reward systems triggered by nicotine. Buproprion's efficacy as a smoking cessation aid has been demonstrated by numerous clinical trials that have compared its effects with those of placebo and other nicotinic substitutes. In 2001, buproprion SR received marketing authorization in France as a smoking cessation aid, under the name ZYBAN®. Tobacco addiction indeed remains a major public health issue. Among patients with psychiatric conditions, chronic tobacco consumption is frequent. The development of non-nicotinic drugs may therefore enhance therapeutic possibilities. However, the psychotropic effects of these molecules should be taken into account. We have recently reported the case of a patient with schizoaffective disorder, who presented two acute bupropion-induced psychotic episodes. We have also undertaken an exhaustive bibliographical research on this subject. The aim of the present study is to present the information available to us, in order to suggest aetiopathogenic hypotheses and therapeutic proposals.
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.