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.

Integria0 个研究点目标入组 20 人开始时间: 2011年5月30日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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

•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

发起方

Integria