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Trial registered on ANZCTR


Registration number
ACTRN12620000847910p
Ethics application status
Submitted, not yet approved
Date submitted
23/06/2020
Date registered
27/08/2020
Date last updated
27/08/2020
Date data sharing statement initially provided
27/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the effects of Medical Cannabis in Reducing Relapse among 20 Patients with Methamphetamine Use Disorder
Scientific title
Safety and Effect of Medical Cannabis on Relapse among 20 Patients with Methamphetamine Use Disorder: A Proof-of-Concept Trial
Secondary ID [1] 301088 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Methamphetamine Use Disorder 317299 0
Condition category
Condition code
Mental Health 315422 315422 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will investigate a Cannabidiol (CBD) dominant cannabis oil product, approximately 200mg/ml of CBD, self-dosed sublingually using an oral syringe twice daily, morning and evening. The study clinician will instruct and coach each participant to self-administer the dose of the study drug via the syringe contained in the drug packaging. Dosing will follow a daily protocol regime, with participants' doses titrated according to positive clinical response and considering any adverse effects. Participants will stay on their last effective dose till the end of the study period. The initial dose will be 0.2ml with a possible maximum dose of 6 ml per day, this dose may be up to a maximum of 1164mg of CBD per day.
Intervention code [1] 317476 0
Treatment: Drugs
Intervention code [2] 317477 0
Rehabilitation
Comparator / control treatment
Twenty participants who have sought treatment for methamphetamine as their primary drug of concern at the same community alcohol and other drug service as the treatment group will be selected from a client management system. Each participant will be selected based on having similar demographics to a matched member of the treatment group. They will receive treatment as usual at the community alcohol and other drug service with the absence of the intervention. This typically involves 6-12 weeks of psycho-social support by nursing and counselling staff at the service.
Control group
Active

Outcomes
Primary outcome [1] 323670 0
To determine the safety of enriched CBD oil for people accessing treatment for methamphetamine use disorder, using the Monitoring of Side Effects Scale (MOSES).
Timepoint [1] 323670 0
Outcomes will be measured on the first day of enrollment and then again the following week. After this initial period, outcomes will be measured on the same day in week 4, 6, 7, 10 and 12.
Primary outcome [2] 323671 0
To determine if enriched CBD oil affects relapse among people accessing treatment for methamphetamine use disorder using the clinician-administered Alcohol, Smoking and Substance Involvement Screening Test.
Timepoint [2] 323671 0
Outcomes will be measured on the first day of enrollment and then again the following week. After this initial period outcomes will be measured on the same day in week 4, 6, 7, 10 and 12.
Primary outcome [3] 324842 0
To determine if enriched CBD oil affects service engagement among people accessing treatment for methamphetamine use disorder by viewing participant attendance records at the treatment centre. Frequency of engagement with the services, as measured by frequency of Did Not Attend (DNA) appointments.
Timepoint [3] 324842 0
Outcomes will be measured on the first day of enrollment and then again the following week. After this initial period outcomes will be measured on the same day in week 4, 6, 7, 10 and 12.
Secondary outcome [1] 382546 0
To determine if Enriched CBD oil affects sleep quality using the Pittsburgh Sleep Quality Index (PSQI).
Timepoint [1] 382546 0
Outcomes will be measured on the first day of enrollment and then again the following week. After this initial period outcomes will be measured on the same day in week 4, 6, 7, 10 and 12.
Secondary outcome [2] 382547 0
To determine if Enriched CBD oil affects mental state using the Depression, Anxiety and Stress Scale 21 (DASS-21).
Timepoint [2] 382547 0
Outcomes will be measured on the first day of enrollment and then again the following week. After this initial period outcomes will be measured on the same day in week 4, 6, 7, 10 and 12.
Secondary outcome [3] 385899 0
To determine if enriched CBD oil affects craving for methamphetamine among people accessing treatment for methamphetamine use disorder who have ceased using methamphetamine using a visual analogue scale of craving.
Timepoint [3] 385899 0
Outcomes will be measured on the first day of enrollment and then again the following week. After this initial period outcomes will be measured on the same day in week 4, 6, 7, 10 and 12.

Eligibility
Key inclusion criteria
- Aged between 18 and 60 years (inclusive);
- Ability to give informed consent;
- Have met DSM-5 criteria for methamphetamine use disorder in the past 12 months;
- Abstinent from methamphetamine for 5-14 days prior to enrolment;
- Agree to a referral to an outpatient clinic for psychological services;
- Previous use of cannabis; and,
- Willing and able to follow study instructions and likely to complete all study requirements.
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of diagnosed psychotic disorder;
- Family history of a diagnosed psychotic disorder or Type I bipolar disorder;
- Admission to an inpatient mental health service for more than one week in the past 12 months;
- Current cannabis use;
- Pregnancy, lactation, or if sexually active is not on effective contraception;
- Prior sensitivity or allergy to CBD or any cannabis-derived product;
- Currently being treated with any medication that contraindicates with CBD, or which in the doctor’s opinion puts the participant at significant risk, could confound the study results, or may interfere significantly with the person’s participation in the study;
- Participation in any investigational drug study within 30 days prior to screening;
- Clinically significant (as judged by the participant’s doctor at alcohol and other drug service) presence of acute illness (e.g. gastrointestinal illness, infection such as influenza, upper respiratory tract infection) at admission to the service;
- Abnormal liver or thyroid function, or haematological findings (>15% above or below normal range);
- Acute or unstable systemic medical disorder;
- History of brady- or tachy-dysrhythmias;
- History of heart failure or heart disease;
- Positive screen for hepatitis B surface antigen, Hepatitis C Virus and Human Immunodeficiency Virus;
- Any condition, which in the doctor’s opinion, puts the participant at significant risk, could confound the study results or may interfere significantly with the participant’s participation in the study;
- Received oral pharmacotherapy for methamphetamine relapse prevention in the past 14 days;
- Received naltrexone implant pharmacotherapy in the past 6 months; or,
- Anticipated need for surgery or hospitalisation during the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Matched-control group
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 305524 0
Charities/Societies/Foundations
Name [1] 305524 0
Medical Cannabis Research Australia (Limited)
Address [1] 305524 0
67 Howe Street
Osborne Park
WA 6017
Country [1] 305524 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Cannabis Research Australia (Limited)
Address
67 Howe Street
Osborne Park
WA 6017
Country
Australia
Secondary sponsor category [1] 306408 0
University
Name [1] 306408 0
Edith Cowan University
Address [1] 306408 0
270 Joondlaup Drive
Joondalup
WA 6030
Country [1] 306408 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305836 0
North Metro Mental Health Human Research Ethics Committee
Ethics committee address [1] 305836 0
NMHS Mental Health REGO
Executive Officer
Gascoyne House, Graylands Campus
Locked Bag No. 1
PO CLAREMONT WA 6919
Ethics committee country [1] 305836 0
Australia
Date submitted for ethics approval [1] 305836 0
31/07/2020
Approval date [1] 305836 0
Ethics approval number [1] 305836 0

Summary
Brief summary
The primary objective of this open-label matched control trial is to examine the safety and efficacy of enriched CBD oil for reducing relapse among people accessing treatment for methamphetamine use disorder. The effect of enriched CBD oil on depression, anxiety and sleep will also be evaluated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101766 0
Dr Stephen Bright
Address 101766 0
Edith Cowan University
270 Joondalup Dr
Joondalup WA 6027
Country 101766 0
Australia
Phone 101766 0
+61 08 6304 2597
Fax 101766 0
Email 101766 0
s.bright@ecu.edu.au
Contact person for public queries
Name 101767 0
Dr Stephen Bright
Address 101767 0
Edith Cowan University
270 Joondalup Dr
Joondalup WA 6027
Country 101767 0
Australia
Phone 101767 0
+61 08 6304 2597
Fax 101767 0
Email 101767 0
s.bright@ecu.edu.au
Contact person for scientific queries
Name 101768 0
Dr Stephen Bright
Address 101768 0
Edith Cowan University
270 Joondalup Dr
Joondalup WA 6027
Country 101768 0
Australia
Phone 101768 0
+61 08 6304 2597
Fax 101768 0
Email 101768 0
s.bright@ecu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results