None listed
Conditions
Brief 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
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 k
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.
Sponsors
Integria
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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
Outcome results
None listed