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

Phase 3

Completed

• Conditions: Mental Health - Anxiety; Anxiety; Mood; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12611000548932
• Lead Sponsor: Integria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

Exclusion Criteria

1.Diagnosis of Psychotic or Bipolar illness, or Major Depressive Disorder
2.Significant suicidal ideation in the previous 6 months
3.Current use of the following medications: antidepressants, mood stabilisers, antipsychotics, opiod, analgesics, St John’s wort, HIV, anti-tumoral/cancer, blood pressure, warfarin, Parkinson’s, epileptic, migraine or anti-ulcer medications
4.Diagnosed hepato-biliary disease/inflammation
5.Substance abuse or dependency disorder including alcohol in the previous 6 months
6.Previous adverse reaction to kava or benzodiazepines
7.Current smoker (more than one day per week)
8.Regular use of kava or benzodiazepines in the previous 12 months
9.No more than one occasion of benzodiazepine or kava use each week over the past month
10.Pregnancy, trying to conceive, or those who could be pregnant
11.Lack of facility in written or spoken English

Study & Design

• Study Type: Interventional
• Study Design: Not specified