{"id":"kava","safety":{"commonSideEffects":[{"rate":null,"effect":"Hepatotoxicity"},{"rate":null,"effect":"Gastrointestinal upset"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dizziness"}]},"_chembl":null,"_dailymed":{"setId":"486263b6-d642-415e-90fe-372faf87d297","title":"KAVAULT (AVILAMYCIN) POWDER [ELANCO US INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Kava is a plant-derived herbal preparation whose active constituents (kavalactones) interact with multiple neurological pathways, including GABA receptors and monoamine systems, producing sedative and anxiolytic effects. The exact mechanism remains incompletely characterized, but kavalactones appear to enhance GABAergic neurotransmission and modulate dopamine and serotonin signaling. In the context of cancer care, kava has been studied for potential supportive use in managing anxiety and stress-related symptoms in cancer patients.","oneSentence":"Kava contains kavalactones that modulate neurotransmitter activity and may have anxiolytic and anti-inflammatory properties.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:57:58.881Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Anxiety and stress management in cancer patients (supportive care)"}]},"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":21,"reaction":"DRUG INTERACTION"},{"count":9,"reaction":"FATIGUE"},{"count":9,"reaction":"INSOMNIA"},{"count":8,"reaction":"ANXIETY"},{"count":8,"reaction":"FEELING ABNORMAL"},{"count":7,"reaction":"SEROTONIN SYNDROME"},{"count":6,"reaction":"ATRIAL FLUTTER"},{"count":6,"reaction":"DRUG INEFFECTIVE"},{"count":6,"reaction":"PARAESTHESIA"},{"count":6,"reaction":"WEIGHT DECREASED"}],"_approvalHistory":[],"publicationCount":798,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["No brand name"],"phase":"marketed","status":"active","brandName":"Kava","genericName":"Kava","companyName":"Masonic Cancer Center, University of Minnesota","companyId":"masonic-cancer-center-university-of-minnesota","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Kava contains kavalactones that modulate neurotransmitter activity and may have anxiolytic and anti-inflammatory properties. Used for Anxiety and stress management in cancer patients (supportive care).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}