Kava Anxiety-Lowering Medication (KALM) Project

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2011
INTERVENTION: Participants will be randomly allocated to one of three treatments at each session during the study (A,B,C). At the end of the study they will have taken all of the interventions individually. The trial treatments are kava, oxazepam and placebo. Participants must take the four tablets simultaneously once during each of the testing session. Randomised to either: A)Oxazepam treatment ‐ 1 oxazepam tablet (30mg) and 3 kava placebo (0mg) B) Kava treatment ‐ 1 oxazepam placebo tablet (0mg) and 3 kava (60mg each = 180mg) tablets C)Placebo treatment ‐ 1 oxazepam placebo tablet (0mg) and 3 kava placebo tablets (0mg) This is a crossover study with a one week washout period between each session. CONDITION: Anxiety Mood PRIMARY OUTCOME: Cognition via computerised cognitive assessment battery exploring effects on quality of memory, speed and accuracy of attention and working memory and a brief pencil and paper memory recall task Driving via driving simulator (indoor on the computer) assessing driving ability Mood and Anxiety via The State‐Trait Anxiety Inventory, ; The State‐Trait‐Cheerfulness‐Inventory (STCI) and ; Bond‐Lader Visual Analogue Scales. SECONDARY OUTCOME: Assess any differences between responders or non‐responders to Kava due to genetic differences (liver enzyme or neurochemical polymorphisms). This will be done via bloods tests analysed by pathology labs. INCLUSION CRITERIA: Participants will be eligible into the study if they have elevated stable levels of stress and anxiety and are not diagnosed with major depressive disorder or bipolar disorder. As there is evidence that kava can interfere with other herbal remedies, prescription medications and over the counter products that share CYP450 metabolism (Singh 2005), enrolled participants will be screened for drugs, alcohol and current medication use. As this is a randomized trial there will be equal probability of the control (placebo) and active (kava/oxazepam) groups to have the same numbers of participants who are currently on medication. Specific INCLUSION CRITERIA: 1.Males and females aged between 18‐65 years of age 2.Must be currently presenting with mild to moderate levels of anxiety (HAM‐A 14 to 25) 3.Fluent in English 4.Participant must provide a signed copy of consent form
Epistemonikos ID: bbe960f37e3281ff6990449e58c9950c7cf05ebc
First added on: Aug 25, 2024