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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
22/04/2024
Date data sharing statement initially provided
10/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Cannabidiol as an Adjunct for the Treatment of Anorexia Nervosa (CAFTAN): An Open Label Pilot Trial with Extension in Young People
Scientific title
Cannabidiol as an Adjunct for the Treatment of Anorexia Nervosa (CAFTAN): An Open Label Pilot Trial with Extension in Young People
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 open label trial will explore the safety and efficacy of Cannabidiol (CBD) as an adjunctive treatment to Maudsley Family Based Treatment (MFBT) in young persons with anorexia nervosa. Participants aged 12-18 years about to commence MFBT in the community will be invited to take part in an open-label cannabidiol (CBD) trial with the drug administered for the first 12 weeks of MFBT. MFBT will last a total of 20 sessions over 6 months. Participants will have an option to enrol in an extension arm to continue taking CBD until the end of their MFBT treatment. CBD oral capsules will be administered in an ascending dose over 4 weeks, starting on 200mg/day to a maximum dose of 800 mg/day a dose maintained until the end of treatment at week 12 or to continue on a dose of 800mg/day until the end of MFBT if deemed appropriate (e.g. no serious adverse events and patient is responding well to drug) by immediate care team and research team. Medication adherence will be measured by monthly urine samples.

MFBT will proceed as usual in the community by a MFBT clinician. The treatment schedule for MFBT sessions includes two sessions per week for the first 2 weeks, followed by weekly sessions for approximately 10 weeks, graduating, pending progress, to one fortnightly MFBT session until week 24. MFBT includes three active phases of treatment, which addresses core issues related to treating anorexia nervosa in young people.

1. Phase 1 (MFBT sessions 1-10, weeks 1-8): Anorexia nervosa is externalised and parents mobilised to support weight restoration of their child in the home setting to increase and return weight to percent median BMI range prior to the onset of the eating disorder. Parents are seen as a central resource in the process of recovery and notions of familial aetiology of the child’s condition are rejected. Siblings are allied with the patient to assist with distress arising as a result of parental control.
2. Phase 2 (MFBT sessions 11-15, weeks 9-15): Phase 2 is instigated once the child has reached 90% expected body weight and a transition is made from parental to adolescent control of eating. Once the adolescent is eating normally and with age-appropriate independence, Phase 3 commences.
3. Phase 3 (MFBT sessions 16-20, weeks 16-24): Assists the family to restart the normal adolescent life-cycle transition that has been stalled since the onset of the illness.

MFBT clinicians will complete an online fidelity check after each session.

No actual change since registration.
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] 332608 0
Assess effects of CBD on usual average weight gain by session 10 (5.46kg) using digital scales.
Timepoint [1] 332608 0
Week 8 post-intervention commencement.
Secondary outcome [1] 414039 0
Assess effects of CBD+MFBT on eating disorder symptoms compared to baseline using Eating Disorder Examination Self-Report Questionnaire (EDE-Q) and Eating Disorder Examination (EDE).
Timepoint [1] 414039 0
Assessed at baseline (week 0), week 12, final MFBT session (week 24) and 3-months post-intervention commencement.
Secondary outcome [2] 414040 0
Assess effects of CBD on a marker of remission, namely >2kg weight gain using digital scales by session 4 in MFBT) compared to published normative percentage (33-40%).

Le Grange D, Huryk KM, Murray SB, Hughes EK, Sawyer SM, Loeb KL. Variability in remission in family therapy for anorexia nervosa. International Journal of Eating Disorders. 2019;52(9):996-1003.
Timepoint [2] 414040 0
Week 2 post-intervention commencement
Secondary outcome [3] 414041 0
Assess rates of remission (defined as weight >95% Median BMI and Eating Disorder Examination - Self-report Questionnaire (EDE-Q) score within 1SD of published norms) at end of treatment compared to published normative results (<40% at end of treatment). Median BMI will be measured by weight using digital scales and height, using a stadiometer.

Le Grange D, Hughes EK, Court A, Yeo M, Crosby RD, Sawyer SM. Randomized clinical trial of parent-focused treatment and family-based treatment for adolescent anorexia nervosa. J Am Acad Child Adolesc Psychiatry. 2016;55(8):683-92.
Timepoint [3] 414041 0
Week 24 post-intervention commencement.
Secondary outcome [4] 414042 0
Determine effects of CBD+MFBT on anxiety using the State-Trait Anxiety Inventory, a self-report questionnaire.
Timepoint [4] 414042 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+MFBT on depression using Beck Depression Inventory, a self-report questionnaire.
Timepoint [5] 414418 0
Assessed at baseline (week 0), week 12, final MFBT session (week 24) and 3-months post intervention commencement.
Secondary outcome [6] 414419 0
Determine effects of CBD+MFBT 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 [6] 414419 0
Assessed at baseline (week 0), week 12, final MFBT session (week 24) and 3-months post intervention commencement.
Secondary outcome [7] 414420 0
Determine effects of CBD+MFBT on obsessive and compulsive symptoms using the Yale-Brown-Cornell Eating Disorders Scale self-report questionnaire.
Timepoint [7] 414420 0
Assessed at baseline (week 0), week 12, final MFBT session (week 24) and 3-months post intervention commencement.

Eligibility
Key inclusion criteria
(a) Females and males aged 12-18 years old
(b) DSM-5 diagnosis of anorexia nervosa
(c) Referral from MFBT clinician and about to commence MFBT
(d) In care of a local GP who agrees to medically monitor patient for the duration of the trial
(e) Willingness to provide informed consent and willingness to participate and comply with all the study requirements (Including full medical examination by general practitioner (GP), agree to be monitored by a study doctor via telemedicine, and urine sampling.
(f) Ability to read, write and understand English.
(g) Availability for the duration of the study.
(h) Referral to a MFBT therapist and about to commence routine MFBT (if the young person and family are already engaged in already in MFBT and have not progressed beyond Phase 1, and are willing to change therapist and restart to session 1 of MFBT they may be eligible to be included in the trial).
(i) Under an eating disorder plan.
Minimum age
12 Years
Maximum age
18 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). 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
6. Participants who have previously completed MFBT
7. Participants currently in MFBT who have progressed to Phase 2
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 8 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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/02/2023
Actual
8/03/2023
Date of last participant enrolment
Anticipated
1/03/2025
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
30
Accrual to date
1
Final
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
King George V Building, Level 9 Missenden Rd, Camperdown NSW 2050
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
Background:
Anorexia Nervosa (AN) has one of the highest mortality rates of any mental illness and very low treatment success rates. AN is characterised by high anxiety around food and weight gain, often beginning in adolescence. Even with the most evidence-based treatment, Maudsley Family-Based Therapy (MFBT), many do not recover. The first phase of MFBT (sessions 1-10), where parents are responsible for re-feeding their child is a universally anxiety provoking phase of treatment, where the child is exposed to increased nutritional intake. CBD has shown promising anti-anxiety effects in young persons with severe anxiety. Participants who are due to commence MFBT in the community will be invited to a simultaneous open-label Cannabidiol (CBD) trial. This trial will explore the safety and efficacy of CBD as an adjunctive treatment to MFBT for young persons aged 12-18 years with AN to determine if outcomes can be improved reducing the anxiety around food and weight-gain, improving compliance to treatment and rates of recovery.

Study Aim:
To determine if CBD treatment is a safe and a well-tolerated intervention in young persons with AN. Moreover, to elucidate whether CBD is an effective adjunct to MFBT in community application. This may improve rates of remission in AN, mediated via a reduction in anxiety.

Hypothesis:
We hypothesise that CBD will reduce anxiety improving the response to MFBT (>5.46kg weight gain by session 10), facilitating nutritional intake prior to the weight maintenance stages during phases 2 and 3 of MFBT. Furthermore we hypothesise that CBD will improve eating disorder psychopathology, rates of remission, depression, obsessive and compulsive symptoms and quality of life.
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 4 03224986
Fax 121876 0
Email 121876 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided 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

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