Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001306707
Ethics application status
Approved
Date submitted
23/09/2022
Date registered
10/10/2022
Date last updated
22/06/2025
Date data sharing statement initially provided
10/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Cannabidiol for the Treatment of Anorexia Nervosa (CAFTAN)
Scientific title
Cannabidiol for the Treatment of Anorexia Nervosa (CAFTAN) in 12-65 years old
Secondary ID [1] 308021 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CAFTAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia nervosa 327702 0
Condition category
Condition code
Mental Health 324782 324782 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will explore the safety and preliminary efficacy of Cannabidiol (CBD) as an adjunctive treatment in people with AN. Participants aged 12-65 years who are engaged in any outpatient psychological treatment for their ED (e.g. MFBT, CBT, DBT) will be invited to take part in an open-label cannabidiol (CBD) trial with the drug administered for 12 weeks, followed by gradual weaning for one week. Dosing will follow a fixed-flexible schedule, starting with 200mg per day for all participants. Doses will be subsequently increased in 200mg increments if participants do not show clinically meaningful improvement (operationalised as a score of 3 or higher on the CGI-I). The maximum dose will be 400mg per day at Week 2, 600mg per day at Week 4 and 800mg at Week 8.
Intervention code [1] 324477 0
Treatment: Drugs
Intervention code [2] 324567 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341902 0
Feasibility of CBD
Timepoint [1] 341902 0
Feasibility will be assessed throughout the 12-week study period, based on the number of eligible participants who choose to enrol and successfully complete the study. This will be determined using enrolment and withdrawal logs.
Primary outcome [2] 332608 0
Assess safety of CBD for the treatment of AN
Timepoint [2] 332608 0
Tolerability of the study medication will be assessed throughout the 12 weeks of the study after each dose increase and fortnightly with a study-specific questionnaire
Secondary outcome [1] 414419 0
Determine effects of CBD on quality of life using either The EQ-5D-Y for young person’s up to the age of 15 years or EQ-5D-5L for those older than 15 years. Both are self-report questionnaires.
Timepoint [1] 414419 0
Assessed at baseline (week 0), week 4, 8, 12 and 3-months post intervention commencement.
Secondary outcome [2] 448913 0
Assess CBD on effects of anxiety - Fear of Food Measure (FOFM)
Timepoint [2] 448913 0
Baseline (week 0), week 4, 8, 12, 3 months follow-up post intervention commencement
Secondary outcome [3] 414420 0
Determine effects of CBD on obsessive and compulsive symptoms using the Yale-Brown-Cornell Eating Disorders Scale self-report questionnaire
Timepoint [3] 414420 0
Assessed at baseline (week 0), week 4, 8, 12 and 3-months post intervention commencement.
Secondary outcome [4] 414039 0
Assess effects of CBD effects on anxiety with OASIS (Overall Anxiety Severity and Impairment Scale )
Timepoint [4] 414039 0
Assessed at baseline (week 0), week 12, final MFBT session (week 24) and 3-months post-intervention commencement.
Secondary outcome [5] 414418 0
Determine effects of CBD on depression using Beck Depression Inventory, a self-report questionnaire
Timepoint [5] 414418 0
Assessed at baseline (week 0), week 4, 8, 12 and 3-months post intervention commencement.
Secondary outcome [6] 414040 0
determine effects of CBD on eating disorder psychopathology (EDE-Q -Eating Disorder Examination – Self-Report Questionnaire )
Timepoint [6] 414040 0
Assessed at baseline (week 0), week 4, 8, 12 and 3-month follow-up
Secondary outcome [7] 414041 0
determine effects of CBD on weight gain by monthly weigh in by GP shared with research team
Timepoint [7] 414041 0
Assessed at baseline (week 0), week 4, 8, 12 and 3-months post intervention commencement.

Eligibility
Key inclusion criteria
• Females and males aged 12-65 years old
• DSM-5 diagnosis of AN
• Referral from a medical practitioner (general practitioner or paediatrician)
• In care of a medical practitioner who agrees to medically monitor patient for the duration of the trial
• Currently under the care of a psychological provider and receiving a psychological intervention (e.g CBT, FBT, DBT etc)
Minimum age
12 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants with a known hypersensitivity or allergy to cannabinoids, including prior clinically significant side effects to cannabis, cannabinoid products or synthetic cannabinoids.
2. Participants with BMI less than 14.
3. Participants with co-occurring physical health conditions (e.g. diabetes, hyperthyroidism, bowel disease, liver disease, liver function tests (LFTs) > 2 x ULN). For the purpose of this study, defined as the presence of an uncontrolled, physical health condition as assessed by a medical doctor (i.e., via a verbal medical history and physical examination).
4. Participants with a past or present history of cannabis dependence as per the ICD-10 criteria.
5. The following medication(s) can possibly have drug-drug interactions with CBD and may cause side effects. Participants on such medications will be excluded from participating in this clinical trial:
• Clobazam
• Valproate
• Topiramate
• Zonisamde
• Rufinamide
• Esclicarbezepine
• Amiodraone
• Levothyroxine
• Other anti-epileptic drugs (AEDS)
• Other medications that are major inducers or inhibitors of CYP enzyme systems
8. Participants with a history or active major psychiatric disorder associated with schizophrenia, psychosis, bipolar disorders or suicide risk.
9. Participants with a current treatment of antipsychotic medication or mood stabilisers.
10. If on antidepressant medication, participants who are not on a stable dose for a minimum of 6 weeks prior to start of the study.
11. Participants treated under the Mental Health Act or under compulsory treatment orders.
12. Participants with a history of drug or alcohol dependency or abuse within the past 2 years.
13. Participants with a history of confirmed seizures or other neurological disorders.
14. Lactating or pregnant women or women intending or attempting to conceive during the trial period
15. Participants with cognitive impairment or insufficient English or literacy to complete study processes.
16. If participant continues to display medical instability, with hospitalisations, investigational drug intervention will be discontinued.
17. Participants required to complete mandatory drug testing for cannabis (e.g., workplace testing, court order).
18. Participants who have been enrolled in a clinical trial and received an investigational medicinal product within the last 3 months.

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
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
10/02/2023
Actual
30/04/2025
Date of last participant enrolment
Anticipated
1/03/2025
Actual
30/04/2025
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
30
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312283 0
University
Name [1] 312283 0
Lambert Initiative for Cannabinoid Therapeutics, University of Sydney
Country [1] 312283 0
Australia
Funding source category [2] 312285 0
University
Name [2] 312285 0
InsideOut Institute for Eating Disorders, University of Sydney
Country [2] 312285 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 313827 0
None
Name [1] 313827 0
Address [1] 313827 0
Country [1] 313827 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311655 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 311655 0
Ethics committee country [1] 311655 0
Australia
Date submitted for ethics approval [1] 311655 0
24/11/2021
Approval date [1] 311655 0
12/05/2022
Ethics approval number [1] 311655 0
2022/ETH00234

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121874 0
Prof Iain McGregor
Address 121874 0
University of Sydney, Level 6, Brain and Mind Centre, 94 Mallett Street, Camperdown, NSW, 2050
Country 121874 0
Australia
Phone 121874 0
+61 2 9351 3571
Fax 121874 0
Email 121874 0
[email protected]
Contact person for public queries
Name 121875 0
Sarah-Catherine Rodan
Address 121875 0
University of Sydney, Level 6, Brain and Mind Centre, 94 Mallett Street, Camperdown, NSW, 2050
Country 121875 0
Australia
Phone 121875 0
+61 4 03224986
Fax 121875 0
Email 121875 0
[email protected]
Contact person for scientific queries
Name 121876 0
Sarah-Catherine Rodan
Address 121876 0
University of Sydney, Level 6, Brain and Mind Centre, 94 Mallett Street, Camperdown, NSW, 2050
Country 121876 0
Australia
Phone 121876 0
+61 477222500
Fax 121876 0
Email 121876 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: All original research data will remain strictly confidential. The de-identified research data will be disseminated in aggregate via conference presentations, peer-reviewed journal publications and media, as applicable, at the completion of the trial. Individual participant data will not be available. There are no commercial interests that are likely to delay or restrict the dissemination of these results. Eligible authors of publications will include investigators who provide substantial contribution to the conception and design of the study, or the acquisition, analysis, or interpretation of data for the work; and drafting the work or revising it critically for important intellectual content; and final approval of the version to be published.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.