Zonisamide + Bupropion for Smoking Cessation

This trial aims to determine if combining zonisamide and bupropion (an antidepressant) can help people switch from regular cigarettes to e-cigarettes more effectively. Participants will be divided into three groups: one receiving both drugs, another receiving bupropion and a placebo, and the last receiving only placebos. The trial seeks adults who smoke at least 10 cigarettes a day and are interested in trying e-cigarettes. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Yes, you must stop taking antidepressants, psychoactive medications, or medications that prolong QTc to participate in the trial.

Yes, you will need to stop taking antidepressants, psychoactive medications, or medications that prolong QTc to participate in this trial.

Research has shown that bupropion is a well-known medication used to help people quit smoking. The FDA has approved it for this purpose, and it is generally considered safe at the recommended dose of 300 mg per day. This dosage helps lower the risk of seizures, which can occur with higher doses.

Studies have indicated that zonisamide might help reduce nicotine withdrawal symptoms. However, reports of side effects like seizures, especially when taken with other medications, suggest its safety may be more complex compared to bupropion.

Caution is advised when using zonisamide and bupropion together. Limited information exists on their combined use. However, testing this combination in a late-stage trial suggests some confidence in its safety at this point.

Researchers are excited about the combination of zonisamide and bupropion for smoking cessation because it offers a novel approach compared to the standard treatments like nicotine replacement therapies, varenicline, and bupropion alone. Zonisamide, typically used for epilepsy and weight loss, introduces a new mechanism of action by potentially influencing neurotransmitter pathways not targeted by existing smoking cessation aids. When combined with bupropion, which is already known to help reduce nicotine cravings and withdrawal symptoms, this duo could enhance the effectiveness of quitting smoking. Additionally, the use of e-cigarettes in this approach may help manage nicotine addiction more flexibly, potentially increasing success rates for individuals trying to quit smoking.

Studies have shown that bupropion can help people quit smoking. In earlier trials, participants taking bupropion had higher success rates compared to those taking a placebo. Specifically, 27% of participants quit smoking with bupropion, while only 11% quit with a placebo after 26 weeks. Research also shows that combining bupropion with nicotine replacement therapy, such as patches, can further increase quit rates. In this trial, some participants will receive bupropion with an e-cigarette, while others will receive a combination of zonisamide and bupropion with an e-cigarette. Zonisamide has been found to reduce withdrawal symptoms and cravings, but it might not help people quit smoking on its own. This trial studies the combination of zonisamide and bupropion to see if it can improve the chances of quitting by better managing cravings and withdrawal symptoms.⁶⁷⁸⁹¹⁰