CompletedPhase 3Phase 4ACTRN12611000548932

Kava Anxiety-Lowering Medication (KALM) Project Acute Kava Mood, Anxiety and Cognition Study

The effects of administration of kava on driving ability, cognition, mood and anxiety measures in comparison to oxazepam and placebo in adults aged 18-65 presenting with current mild to moderate levels of anxiety.

Sponsor

Integria

Enrollment

20 participants

Start Date

Mar 16, 2011

Study Type

Interventional

Conditions

Anxiety Mood

Summary

The objective of this trial is to examine the effects of administration of kava (a plant medicine) on driving ability, cognition, mood and anxiety measures in comparison to oxazepam (a synthetic anti-anxiety drug) and placebo in adults aged 18-65 presenting with current mild to moderate levels of anxiety. 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 treatments consist of kava, oxazepam, or placebo tablets consumed orally. A. Kava (180mg) – 3 X 60mg tablets taken in one session. B. Oxazepam (30mg tablet) - 1 tablet taken in one session. C. Oxazepam placebo 1 tablet taken in one session, or kava placebo 3tablets taken in one session

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates the effects of kava and oxazepam (a benzodiazepine) on mood, anxiety, and thinking ability in adults aged 18-65 with mild to moderate anxiety. It explores whether kava, a traditional herbal remedy from the Pacific Islands, can effectively and safely reduce anxiety symptoms compared to a standard medication and placebo.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.