drugset / Trial / NCT03606655

Exploring the Impact of Two-week Kava on the Metabolism of Nicotine and NNK

NCT03606655 ↗

Phase 1 Withdrawn University of Florida
NaSingle-groupOpen-labelSupportive care

Summary

Tobacco smoking is the leading cause of head and neck cancer in the United States. Smoking cessation remains a challenge for many head/neck cancer survivors, indicating a need for development of more effective smoking cessation interventions. Kava's properties as a proven anxiolytic and carcinogen detoxifier warrant an investigation of its efficacy as an innovative smoking cessation aid. Kava may also influence carcinogen (NNK specifically) metabolism to help reduce carcinogenesis risk.

Timeline

Start
2020-01
Primary completion
2020-10
Completion
2021-01

Outcome

Outcome not reported

Stopped: “Terms could not be met with the FDA.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Kava Unknown 75 mg —

Indications

No indication recorded.