None listed
Conditions
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. There are no pharmacotherapies approved for the treatment of anorexia nervosa (AN) and a need to find novel interventions to improve outcomes. Cannabidiol (CBD) has shown promising anxiolytic therapeutic effects in young people (12-25 years) with severe anxiety as well as young adults with social anxiety disorder. Anxiety is both a major feature of AN and highly prevalent during active treatment of the disorder, providing a strong incentive to explore CBD in people with AN. In an open label design, CBD capsules will be administered as an adjunctive intervention alongside an outpatient psychological intervention for 12 weeks. Safety and preliminary efficacy will be determined in people with AN. Study Aim: To determine if CBD treatment is a safe and a well-tolerated intervention in persons with AN. Moreover, to elucidate whether CBD is effective to reduce anxiety Hypothesis: We hypothesise that CBD is highly tolerable with a high safety profile, with no associated serious adverse events reported in relation to the investigational product. We hypothesise that CBD will reduce anxiety scores throughout the study and at follow-up. Furthermore we hypothesise that CBD will improve eating disorder psychopathology, depression, obsessive and compulsive symptoms and quality of life.
Interventions
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. D
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.
Sponsors
University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
12 Years to 65 Years
Healthy volunteers
No
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)
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.
Outcome results
None listed