ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001001482

Ethics application status

Approved

Date submitted

25/07/2016

Date registered

28/07/2016

Date last updated

2/03/2022

Date data sharing statement initially provided

16/02/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Cannabiol (CBD) for Cannabis and Mood Disorders in Young Adults (CCAMDYA)

Scientific title

Cannabiol (CBD) for Cannabis and Mood Disorders in Young Adults (CCAMDYA)

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

CCAMDYA

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Mood disorders

Cannabis use

Condition category

Condition code

Mental Health

Depression

Mental Health

Addiction

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This is a double blind placebo controlled RCT consisting of two groups. An intervention and a control group.
The intervention group will receive 800mg of CBD will be administered in 200mg capsules. Participants will be required to take 400mg (i.e. 2 capsules) of CBD twice a day (morning and night) approximately 12 hours apart for a 12 week treatment period. The active ingredient is fully synthetic (99.6% Cannabidiol powder dissolved in corn oil encapsulated in gelatine). It is the equivalent isomer of naturally occurring Cannabidiol. The active ingredient is produced at BioSynthesis Pharma Group FDA and MHRA approved facility in the UK.
The matching placebo will be administered in capsules with same appearance and taste and participants will be required to take of the same number of capsules twice daily as participants in the active arm.
All medications received and dispensed as part of this trial will be inventoried and accounted for throughout the trial on the Investigation Agent Accountability Record (study medication log) by the clinical trials pharmacists. The medication will be dispensed weekly for the first month, and then monthly after that. Patient compliance will be assessed through pill counts when participants return to receive their next lot of medication, as well as through self-report measures and the level of CBD in urine from samples collected at baseline, week 2, week 6 and week 12. At the completion of each participant’s treatment period, any unused medications will be returned to the trial pharmacist, documented, and then subsequently destroyed.
All participants will be provided with six 30-50 minute sessions of manualized therapy based on the Ready 2 Change program developed by Turning Point, Eastern Health. This is a semi-structured program involving one-on-one sessions with a trained addictions counsellor. The first two sessions are held weekly, and follow up sessions may be weekly or fortnightly thereafter. After the 12 week intervention period (or if any participant meets exit or withdrawal criteria), treatment as usual will be provided by Department of Addiction Medicine clinicians. For the purposes of the study analyses, ‘entry’ will be considered to be the date the participant commences the study medication.

Intervention code [1]

Treatment: Drugs

Intervention code [2]

Behaviour

Intervention code [3]

Treatment: Other

Comparator / control treatment

The matching placebo will be administered in capsules with the same appearance and taste as active participants (400 mg of glucose i.e. 2 capsules twice a day (800mg in total) approximately 12 hours apart for a 12 week treatment period) will be required to take of the same number of capsules twice daily as participants in the active arm.
Control participants will be treated exactly as active participants and will also receive the same therapeutic intervention as active group.

Control group

Placebo

Outcomes

Primary outcome [1]

Recruitment rate based on audit of study enrolment logs

Timepoint [1]

duration of trial recruitment is estimated to be 10 months

Primary outcome [2]

Adverse events during treatment. This will be assessed by a self-report Adverse Events Checklist administered by a clinician during assessment.

Timepoint [2]

Adverse events will be assessed weekly during the treatment period and at Week 14 after the trial has ended.

Primary outcome [3]

Treatment completion, defined as completing 12 weeks of treatment with CBD under protocol conditions.
This outcome is assessed by whether or not the patient has finished the full 12 week treatment period. Any exit before this time will be considered as incomplete treatment.

Timepoint [3]

12 week end of treatment

Secondary outcome [1]

At treatment entry, urine profiles of cannabinoid metabolites (THC and its primary metabolite (THC-COOH) and CBD and its primary metabolite (CBD-7-oic acid)) from prior illicit cannabis use (measured at baseline) will be collected. The same measures will be repeated after CBD has been administered to participants (taken on week 1, 2, 6 and 12).

Timepoint [1]

Weeks 1, 2, 6 and 12

Secondary outcome [2]

To determine whether there is evidence of an interaction with the efficacy of CBD and mental health outcomes at end of treatment. This is a composite secondary outcome which will be assessed through;; Australian Treatment Outcome Profile, CPQ, QIDS, Kessler Psychological Distress Scale, Severity of Dependence Scale, Pittsburgh Sleep Quality Index, Depression Anxiety and Stress Scale, WHO-QoL- BREF, Young Mania Rating Scale, Clinical Global Impressions Scale.

Timepoint [2]

12 week end of treatment

Secondary outcome [3]

Self-reported measures of cannabis use (quantity and frequency) using Time Line Follow Back Method

Timepoint [3]

Weekly for twelve weeks after enrolment in trial

Eligibility

Key inclusion criteria

• At least greater than or equal to 18 years of age & less than 28 years of age at presentation.
• Moderate to severe DSM 5 Cannabis Use Disorder
• Cannabis use on average at least greater than or equal to 3 days per week (over last 28 days).
• Desire to reduce or cease cannabis use
• Moderate to severe depression, indicated by a score greater than or equal to 11 and less than or equal to 20 on the QIDS-C at first contact with the service.
• A diagnosis of a mood disorder with or without psychotic features at baseline using a structured clinical interview.
• Fluent in English.
• Able to give informed consent.
• Agree to participate in all tests, including urine and saliva drug screens.
• Prepared to take trial medications as requested.

Minimum age

18 Years

Maximum age

28 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• More than fortnightly use of an illicit drug in the last 28 days (other than cannabis).
• Dependence on a substance other than cannabis and tobacco.
• Acute suicidal behaviour.
• Evidence of severe medical condition (including, severe hepatic (LFTs more than 5 times normal) and/or renal impairment (estimated GFR <60) or cardiovascular disease (hx of congential heart disease), or cognitive impairment (documented evidence of neuropsychological impairment)).
• People with current prescriptions (within past month) for antipsychotic medications or tricyclic antidepressants.
• Known or suspected allergy to cannabinoids, propylene glycol, ethanol, peppermint oil, corn oil or gelatine.
• Females who are pregnant, lactating, or not using adequate contraception.
• Males who are not using adequate contraception.

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)

Before trial commencement, allocation to treatment will be concealed and carried out by a clinical trial pharmacist at SVHM uninvolved with the conduct of the participant assessment. Each of the participant’s identifying numbers (CBD_CA_MD_01 to CBD_CA_MD_30) will be randomised by the clinical trial pharmacist via a computer-generated algorithm to one of two possible treatment groups (placebo group or CBD group) and recorded on the Treatment Allocation form. The participants, treating clinicians, and research personnel will remain blinded to treatment allocation until database lock.
The DoAM staff will assist in identifying potential participants. Individuals will be assessed for eligibility at initial contact with DoAM by a clinician as part of routine clinical assessment. Once a potential participant has been identified as fitting each of the eligibility criteria, they will be recruited by an investigator into the study and allocated the next Identifying Number on the Master Index list. Access to un-blinding will be available through the clinical trial pharmacist who will have access to the Treatment Allocation form, and the Chief Investigator who will have access to the thirty individually sealed envelopes with each participant’s treatment allocation at SVHM Department of Addiction Medicine. The individual participant’s treatment allocation will be made available and validated for emergency situations.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Primary analyses will be undertaken on an intention to treat basis, including all participants as randomised, regardless of treatment actually received.
Count variables (AEs, number of counselling sessions, retention i.e. weeks in treatment) will be compared between treatment arms using Fishers exact test. All tests will be conducted using a two-sided alpha level of 0.05 and 95% confidence intervals.
Analysis of total days of cannabis use across the 12 weeks of treatment will be analysed using the chi-square test to compare the proportion between the two treatment arms (active versus placebo).
Effectiveness of CBD on other secondary outcome variables will be established using a planned contrast of change from baseline to the week 12 end point in the active compared with placebo condition within a mixed model repeated measures analysis.
All statistical analyses will be conducted with Stata/SE 15.1. Any deviation from planned statistical analyses will be described in detail and reported in the final report, along with justification of the amendment(s).

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/03/2022

Actual

17/02/2022

Date of last participant enrolment

Anticipated

1/11/2022

Actual

Date of last data collection

Anticipated

1/05/2023

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment postcode(s) [1]

3065 - Fitzroy

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St Vincent's Hospital Melbourne

Address [1]

55 Victoria Parade, Fitzroy Victoria Australia 3065

Country [1]

Australia

Primary sponsor type

Hospital

Name

St Vincent's Hospital Melbourne

Address

55 Victoria Parade Fitzroy Vic 3065

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Other Collaborative groups

Name [1]

Australian Centre for Cannabinoid Clinical and Research Excellence (ACRE)

Address [1]

Hunter Medical Research Institute
C/- The University of Newcastle
University Drive
Callaghan NSW 2308
Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital Melbourne HREC

Ethics committee address [1]

55 Victoria Parade Fitzroy Victoria 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/08/2018

Approval date [1]

06/03/2019

Ethics approval number [1]

HREC 188/18

Summary

Brief summary

The primary objectives of the study is to examine the feasibility, safety and efficacy of cannabidiol (CBD) in the management of concurrent mood and cannabis use disorders in young people, in a randomized controlled study. Specifically, the study will assess recruitment rates,  retention rates, adverse events, the quantity and frequency of cannabis use, and the impact of CBD on patient mental health outcomes and well-being. 
Current treatments for anxiety and depression are of limited efficacy in a considerable proportion of patients (30% of depressed patients are pharmacoresistant) and are associated with troublesome side effects that reduce compliance; the development of novel, improved therapeutic treatments would fill a considerable unmet medical need. CBD has emerged as one of the most promising candidates in treating psychiatric disorders. Research suggests that greater rates of mental health problems in cannabis users are related to increased use of high THC/low CBD varieties of cannabis. In various animal and human laboratory and clinical studies, CBD has been found to reduce the intoxicating and psychotomimetic effects of THC, while CBD given alone has also been found to relieve anxiety and nausea and to have anti-inflammatory and antipsychotic effects.
Thirty participants (male and female) will be recruited over a period of 9 months. The study will be conducted in the Department of Addiction Medicine at St Vincent's Hospital Melbourne. Participants will complete an initial assessment  as per normal clinical practice. Eligible participants will be contacted to attend a baseline assessment and informed consent..  Participants will be randomized into either a CBD or placebo treatment group for a period of 12 weeks with follow-up at 14 weeks. All participants will be offered up to 6 sessions of manualised psychotherapy as per standard clinical practice.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Yvonne Bonomo

Address

Department of Addiction Medicine
St Vincent's Hospital Melbourne
55 Victoria Parade
Fitzroy Victoria 3065

Country

Australia

Phone

+61 3 92316940

Fax

yvonne.bonomo@svha.org.au

Contact person for public queries

Name

Amanda Norman

Address

Department of Addiction Medicine
St Vincent's Hospital Melbourne
55 Victoria Parade
Fitzroy Victoria 3065

Country

Australia

Phone

+61 3 92316947

Fax

amanda.norman@svha.org.au

Contact person for scientific queries

Name

Amanda Norman

Address

Department of Addiction Medicine
St Vincent's Hospital Melbourne
55 Victoria Parade
Fitzroy Victoria 3065

Country

Australia

Phone

+61 3 92316947

Fax

amanda.norman@svha.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Email
15115	Study protocol	amanda.norman@svha.org.au
15116	Informed consent form	amanda.norman@svha.org.au
15117	Ethical approval	amanda.norman@svha.org.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Cannabidiol for Mood Disorders: A Call for More Research.	2021	https://dx.doi.org/10.1177/0706743720926798

N.B. These documents automatically identified may not have been verified by the study sponsor.

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