{"id":"kava-piper-methysticum","safety":{"commonSideEffects":[{"rate":null,"effect":"Hepatotoxicity"},{"rate":null,"effect":"Gastrointestinal upset"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Skin rash"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The active kavalactones in kava (particularly kavain and methysticin) interact with multiple CNS targets including GABA receptors, monoamine oxidase inhibition, and calcium/sodium channel modulation. These mechanisms collectively reduce anxiety and promote relaxation. The exact primary mechanism remains incompletely characterized, though GABAergic potentiation is considered a major contributor.","oneSentence":"Kava contains kavalactones that modulate neurotransmitter activity and ion channels, producing anxiolytic and sedative effects.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:50:56.181Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Anxiety disorders"},{"name":"Stress-related conditions"}]},"trialDetails":[{"nctId":"NCT07469527","phase":"NA","title":"Effects of Feel Free® Classic Tonic on Stress and Pharmacokinetics in Healthy Adults","status":"RECRUITING","sponsor":"Botanic Tonics, LLC","startDate":"2026-03-07","conditions":"Anxiety, Physiological Stress, Stress","enrollment":165},{"nctId":"NCT06177535","phase":"NA","title":"A Study of Oral Kavalactones Effect on Nurses","status":"RECRUITING","sponsor":"Mayo Clinic","startDate":"2024-08-05","conditions":"Stress","enrollment":200},{"nctId":"NCT05081882","phase":"PHASE2","title":"Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Florida","startDate":"2022-06-09","conditions":"Smoking","enrollment":20},{"nctId":"NCT06213298","phase":"EARLY_PHASE1","title":"Effect of Kava on Anxiety and Stress in Cancer Survivors","status":"SUSPENDED","sponsor":"Masonic Cancer Center, University of Minnesota","startDate":"2024-06-20","conditions":"Kava, Anxiety, Stress","enrollment":43},{"nctId":"NCT07219186","phase":"EARLY_PHASE1","title":"Kava Aging and Mobility Study","status":"NOT_YET_RECRUITING","sponsor":"University of Florida","startDate":"2026-04","conditions":"Old Adults, Sleep Quality, Kava","enrollment":40},{"nctId":"NCT05814055","phase":"PHASE2","title":"The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence","status":"RECRUITING","sponsor":"University of Florida","startDate":"2024-06-06","conditions":"Smoking","enrollment":76},{"nctId":"NCT04565145","phase":"PHASE2","title":"Biomarker Changes and Anxiolytic Effects-Phase 2","status":"COMPLETED","sponsor":"University of Florida","startDate":"2021-04-05","conditions":"Pharmacokinetics","enrollment":39},{"nctId":"NCT05229354","phase":"PHASE2","title":"Dengue Controlled Human Infection Model in Dhaka, Bangladesh","status":"ACTIVE_NOT_RECRUITING","sponsor":"Beth Kirkpatrick","startDate":"2021-12-11","conditions":"Dengue","enrollment":192},{"nctId":"NCT03843502","phase":"PHASE1","title":"A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics","status":"COMPLETED","sponsor":"University of Florida","startDate":"2020-02-26","conditions":"Pharmacokinetics","enrollment":10},{"nctId":"NCT05381025","phase":"NA","title":"Kavalactones on Sleep and Cortisol in Healthy Special Forces Trainees","status":"COMPLETED","sponsor":"Thorne HealthTech, Inc","startDate":"2022-05-11","conditions":"Sleep","enrollment":15},{"nctId":"NCT03606655","phase":"PHASE1","title":"Exploring the Impact of Two-week Kava on the Metabolism of Nicotine and NNK","status":"WITHDRAWN","sponsor":"University of Florida","startDate":"2020-01","conditions":"Kava on the Metabolism of Nicotine and NNK","enrollment":""},{"nctId":"NCT02219880","phase":"PHASE4","title":"Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial","status":"COMPLETED","sponsor":"University of Melbourne","startDate":"2015-10-13","conditions":"Generalized Anxiety Disorder","enrollment":178},{"nctId":"NCT02500472","phase":"NA","title":"Investigation of Kava Effects on NNK Metabolism","status":"COMPLETED","sponsor":"Masonic Cancer Center, University of Minnesota","startDate":"2015-12-03","conditions":"Tobacco Smoking","enrollment":24},{"nctId":"NCT00083980","phase":"PHASE2","title":"Kava Kava for the Treatment of Generalized Anxiety Disorder (GAD)","status":"TERMINATED","sponsor":"National Center for Complementary and Integrative Health (NCCIH)","startDate":"2002-06","conditions":"Anxiety Disorders","enrollment":16},{"nctId":"NCT00451516","phase":"PHASE2","title":"St. John's Wort And Kava In The Treatment Of Major Depressive Disorder With Comorbid Anxiety","status":"COMPLETED","sponsor":"The University of Queensland","startDate":"2007-03","conditions":"Depressive Disorder, Major, Anxiety Disorders","enrollment":50},{"nctId":"NCT00009542","phase":"PHASE4","title":"Effects of Kava on the Body's Elimination of Caffeine and Dextromethorphan","status":"COMPLETED","sponsor":"National Institutes of Health Clinical Center (CC)","startDate":"2001-01","conditions":"Healthy","enrollment":20}],"_emaApprovals":[],"_faersSignals":[{"count":2,"reaction":"ABDOMINAL DISCOMFORT"},{"count":2,"reaction":"ABDOMINAL PAIN"},{"count":2,"reaction":"DECREASED APPETITE"},{"count":2,"reaction":"DIARRHOEA"},{"count":2,"reaction":"FATIGUE"},{"count":2,"reaction":"INTENTIONAL DOSE OMISSION"},{"count":2,"reaction":"NAUSEA"},{"count":2,"reaction":"PRODUCT DOSE OMISSION ISSUE"},{"count":2,"reaction":"SOMNOLENCE"},{"count":1,"reaction":"ABDOMINAL DISTENSION"}],"_approvalHistory":[],"publicationCount":129,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"kava (Piper methysticum)","genericName":"kava (Piper methysticum)","companyName":"National Institutes of Health Clinical Center (CC)","companyId":"national-institutes-of-health-clinical-center-cc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Kava contains kavalactones that modulate neurotransmitter activity and ion channels, producing anxiolytic and sedative effects. Used for Anxiety disorders, Stress-related conditions.","enrichmentLevel":3,"visitCount":2,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}