Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000548932
Ethics application status
Approved
Date submitted
25/05/2011
Date registered
30/05/2011
Date last updated
9/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Kava Anxiety-Lowering Medication (KALM) Project
Acute Kava Mood, Anxiety and Cognition Study
Scientific title
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.
Secondary ID [1] 262203 0
None
Universal Trial Number (UTN)
Trial acronym
KALM acute
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 267897 0
Mood 267898 0
Condition category
Condition code
Mental Health 268046 268046 0 0
Anxiety
Alternative and Complementary Medicine 268047 268047 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 264606 0
Treatment: Drugs
Comparator / control treatment
Placebo tablet is a sugar pill, identical in taste and appearance but without the active ingredient (Kava and oxazepam)

Treatment C which consists of 1 oxazepam placebo tablet (0mg) and 3 kava placebo tablets (0mg) is the placebo condition
Control group
Placebo

Outcomes
Primary outcome [1] 266790 0
Driving via driving simulator (indoor on the computer) assessing driving ability
Timepoint [1] 266790 0
Data collection will occur during week 0 at baseline and at sessions 1, 2 and 3 which will be 3-5 days apart
Primary outcome [2] 266845 0
Mood and Anxiety via The State-Trait Anxiety Inventory,
The State-Trait-Cheerfulness-Inventory (STCI) and
Bond-Lader Visual Analogue Scales.
Timepoint [2] 266845 0
Data collection will occur during week 0 at baseline and at sessions 1, 2 and 3 which will be 3-5 days apart
Primary outcome [3] 266846 0
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
Timepoint [3] 266846 0
Data collection will occur during week 0 at baseline and at sessions 1, 2 and 3 which will be 3-5 days apart
Secondary outcome [1] 276395 0
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.
Timepoint [1] 276395 0
Data collection will occur during week 0 at baseline and at the last testing session

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A disinterested third party generated the randomisation list using a computerised random number sequence generator. Allocation involved contacting the holder of the allocation schedule who is off-site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be contacted via avertisements in health clinics and on community notice boards. Participants will be screened to ensure they pass the inclusion/exclusion criteria and allocated a participant number and treatment condition.

Eligible recruited participants will be assigned a participant number. The treatment number that has been placed next to the participant’s number will be the allocated treatment for that individual.

Blinding will be achieved by enlisting a person outside of the project to code the treatments, and maintain the key to this code until data collection is completed. An emergency code break envelope will be provided to the principle investigator which will only be opened in case of emergency. If this occurs, the sponsor and the ethics committee will be informed. The codes will only be broken in an emergency, such as an SAE that requires knowledge of the treatment being taken in order to manage a participant’s condition.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/02/2011
Actual
16/03/2011
Date of last participant enrolment
Anticipated
Actual
6/08/2011
Date of last data collection
Anticipated
Actual
6/10/2011
Sample size
Target
20
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 4043 0
3022

Funding & Sponsors
Funding source category [1] 267113 0
Commercial sector/Industry
Name [1] 267113 0
Integria
Country [1] 267113 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Integria
Address
Level 1, 8
Clunies Ross Court, Eight Mile Plains Qld 4300
Country
Australia
Secondary sponsor category [1] 264192 0
None
Name [1] 264192 0
Address [1] 264192 0
Country [1] 264192 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269124 0
Swinburne's Human Research Ethics Committee (SUHREC)
Ethics committee address [1] 269124 0
PO Box 218
Hawthorn VIC 3122
Ethics committee country [1] 269124 0
Australia
Date submitted for ethics approval [1] 269124 0
01/09/2010
Approval date [1] 269124 0
06/01/2011
Ethics approval number [1] 269124 0
2010/210

Summary
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
Trial website
Trial related presentations / publications
J. Sarris , E. LaPorte , A. Scholey , R. King , A. Pipingas , I. Schweitzer
& C. Stough (2013) Does a Medicinal Dose of Kava Impair Driving? A Randomized,
Placebo-Controlled, Double-Blind Study, Traffic Injury Prevention, 14:1, 13-17, DOI:
10.1080/15389588.2012.682233
Public notes

Contacts
Principal investigator
Name 32627 0
Dr Jerome Sarris
Address 32627 0
The Melbourne Clinic 130 Church St, Richmond Victoria, 3121
Country 32627 0
Australia
Phone 32627 0
+613 9420 9350
Fax 32627 0
Email 32627 0
[email protected]
Contact person for public queries
Name 15874 0
Dr Jerome Sarris
Address 15874 0
The Melbourne Clinic

130 Church St, Richmond

Victoria, 3121
Country 15874 0
Australia
Phone 15874 0
+613 9420 9350
Fax 15874 0
Email 15874 0
[email protected]
Contact person for scientific queries
Name 6802 0
Dr Jerome Sarris
Address 6802 0
The Melbourne Clinic

130 Church St, Richmond

Victoria, 3121
Country 6802 0
Australia
Phone 6802 0
+613 9420 9350
Fax 6802 0
na
Email 6802 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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