Kava and Kratom for Pharmacokinetics

This trial examines how the body processes a herbal supplement called Feel Free® Tonic, which contains Kava, Kratom, or both. Researchers aim to understand how each ingredient behaves individually and in combination, focusing on their pharmacokinetic profiles—how the body absorbs, distributes, metabolizes, and excretes them—and their safety. The trial involves different groups taking either a mix of Kava and Kratom, only Kava, or only Kratom. It seeks healthy adults who haven't used nicotine, Kava, or Kratom more than three times in the past three months and can adhere to certain lifestyle restrictions during the study. As an unphased trial, this study allows participants to contribute to foundational research on herbal supplements.

The trial requires participants to stop using medications that are metabolized by certain liver enzymes or have effects on the central nervous system, such as antidepressants or antipsychotics. If you're taking such medications, you may need to stop them to participate.

In a previous study, researchers examined the safety of using both kava and kratom together. They found limited information on the safety of their combined use. However, kava alone has been linked to liver damage and other harmful effects, especially with heavy use. Kratom has also been associated with serious health issues, such as liver damage and seizures. Both substances can affect mood and cognition.

Kava was once considered a safe option for treating anxiety, but concerns about liver health have prompted warnings. The FDA advises against using kratom due to the risk of serious side effects and addiction. Some studies suggest kratom might be safe at certain doses, but caution is necessary because of these risks.

Researchers are excited about these treatments because Kava and Kratom offer a natural alternative to traditional medications for mood enhancement and relaxation. Unlike common pharmaceutical options, which often include synthetic compounds and may have significant side effects, Kava and Kratom are derived from plant-based ingredients. The Kava root extract and dried Kratom leaf powder in these treatments provide a unique combination that potentially offers mood-lifting and relaxing effects without the harsh side effects associated with synthetic drugs. Additionally, the trial is exploring the pharmacokinetics of these herbal supplements, which could reveal new insights into their absorption and efficacy in the body.

This trial will compare different formulations of kava and kratom. Studies have shown that kava contains natural compounds that help with relaxation and reduce anxiety by affecting brain chemicals that calm nerves. Research indicates that kratom contains a substance that interacts with the body's pain relief system to ease pain and either boost mood or energy, depending on the dose. Participants in this trial may receive a half-strength combination of kava and kratom, a kava-only variant, or a kratom-only variant. While some evidence supports their individual benefits, more research is needed to understand their safety and effectiveness when combined. It is important to note that kratom has been linked to serious health risks, including liver damage and addiction.¹²³⁵⁶