None listed
Conditions
Brief summary
Anxiety disorders are one of the most common mental health conditions in young people, affecting around 7% of adolescents in Australia. Yet, the rate of inadequate treatment response and corresponding functional impairment in anxiety is high. Cannabidiol (CBD), a main component of Cannabis, can effectively reduce anxiety in adults with social anxiety disorder and has found to be safe and well tolerated in children and adolescents with epilepsy. The current study team have previously tested CBD (up to 800 mg/day for 12 weeks) in a pilot study involving in 31 individuals (mean 21 yrs) with treatment resistant anxiety disorders (ACTRN12617000825358). Two-thirds of participants had a >33% reduction in anxiety severity and 40% of participants had >50% reduction at 12 weeks. CBD was well tolerated with no severe, or unexpected adverse events; 94% of participants completed the intervention, indicating high acceptability. Thus, CBD may be a suitable candidate intervention for youth with inadequate response to anxiety treatments. This is a two-armed randomised control trial in 180 young people with a treatment-resistant anxiety disorder aged 12-25 years, randomised to receive CBD (600mg -800mg/d) or placebo equivalent at a 1:1 ratio, for 12 weeks. Ethics approval was received on 24/10/2023.
Interventions
The CANCAN Study is a double-blind, randomised, placebo-controlled two-armed trial investigating the benefits of 600-800mg/day Cannabidiol (CBD) in 180 young people with a current diagnosis of an anxiety disorder without clinically meaningful improvement in response to standard care.
Intervention: CBD or placebo (per oral) – doses of 600-800 mg per day (fixed-flexible schedule) for 12 weeks. Capsules contain 200mg active CBD or placebo. Doses will start at 600 mg per day (1 capsule in the morn
The CANCAN Study is a double-blind, randomised, placebo-controlled two-armed trial investigating the benefits of 600-800mg/day Cannabidiol (CBD) in 180 young people with a current diagnosis of an anxiety disorder without clinically meaningful improvement in response to standard care. Intervention: CBD or placebo (per oral) – doses of 600-800 mg per day (fixed-flexible schedule) for 12 weeks. Capsules contain 200mg active CBD or placebo. Doses will start at 600 mg per day (1 capsule in the morning, 2 capsules at night). Participants are seen by the study doctor every 4 weeks throughout the study. At week 4 or 8, in participants who are considered not “much improved” by the study doctor (i.e., CGI-I score >2) the daily dose will be increased from 3 to 4 capsules if tolerated (2 capsules twice a day). All study participants will also receive psychosocial treatment (here referred to as treatment as usual, TAU) for the duration of the trial. TAU may vary across participants as clinically indicated depending on individual need. The specific type of psychosocial treatment and number of treatment sessions will be documented at every study visit. Adherence to the study medication will be assessed by pill counts upon return of medication to the Research Assistant or pharmacist. Pill count verification will also be conducted by the pharmacy and a subset of this data by the unblinded monitor. Objective quantification of cannabinoid levels will be obtained via regular urine samples throughout the treatment phase.
Sponsors
Orygen Centre for Youth Mental Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
12 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 12-25 (inclusive) at entry; 2. Ability to give informed consent and adhere to study procedures (parental or guardian consent will be obtained for those aged <18 years); 3. Sufficient fluency in English (for assessment purposes); 4. Diagnosis of a DSM-5 anxiety disorder (i.e., social anxiety disorder, panic disorder, separation anxiety disorder, specific phobia, agoraphobia, generalized anxiety disorder); 5. Anxiety symptoms and functional impairment despite receiving TAU for at least 2 months, indicated by a score of greater than or equal to 10 on the OASIS, and lack of clinically meaningful improvement (CGI-I score = 2).
Exclusion criteria
1. Prior sensitivity or allergy to cannabidiol (CBD) or any cannabis-derived product; 2. Current treatment with anxiolytic medication e.g. benzodiazepines or beta blockers; 3. If prescribed permitted psychotropic (e.g. antidepressant medication), the individual has not been on a stable dose for a minimum of 4 weeks; 4. Pregnancy, lactation, or if sexually active, no effective contraception; 5. Clinical blood test findings that might compromise participant safety or confound the trial results; 6. History of DSM-5 schizophrenia spectrum, delusional, bipolar I disorder, or current substance/medication induced psychotic disorder; 7. Acute or unstable systemic medical disorder; 8. Any metabolic, endocrine or other physical illness, e.g. thyroid disease, with neuropsychiatric consequences which may compromise the safety of the participant or the conduct of the trial; 9. Acute suicidality (indicated by a score of 3 on QIDS-A17-C item 13) or severe depression (indicated by a score of >20 on the QIDS-A17-C ); 10. Severe disturbance, such that the person is unable to comply with either the requirements of informed consent or the treatment protocol.
Outcome results
None listed