CANNABIDIOL for Post-traumatic stress disorder | Anxiety disorders

Inclusion criteria

• {"criterion_text":"- Dutch uniformed personnel, which are (former) police-officers, firefighters, ambulance paramedics, military personnel or veterans.\n- Age between 18-65\n- Waiting for therapy for the treatment of a trauma and stressor-related and/or an anxiety disorder (as determined by the MINI PLUS psychiatric interview)"}

Exclusion criteria

• {"criterion_text":"- Severe co-morbidity (severe major depressive or bipolar disorder and/or psychosis)\n- Alcohol and/or drug dependence\n- Inability to adequately read or speak Dutch\n- (a history of) epilepsy or brain damage, cardiac, renal or liver abnormalities\n- (a history of) allergies to medication (adverse reactions or rash)\n- Individuals taking certain medications known to have potential interactions with CBD (i.e., steroids, HMG-CoA reductase inhibitors, calcium channel blockers, antihistamines, antivirals, immune modulators, benzodiazepines, anti-arrhythmic, antibiotics, anesthetics, antipsychotics, antidepressants, anti-epileptics, beta blockers, proton pump inhibitors, NSAIDs, angiotensin II blockers, oral hypoglycemic agents, and sulfonylureas)\n- Used cannabis, synthetic cannabinoid, cannabinoid analogue, or any CBD or THC-containing product within 30 days of eligibility screening.\n- Individuals that had been diagnosed with intestinal, liver, or renal diseases that would affect absorption or clearance of CBD\n- For women: pregnant, a wish to become pregnant, or nursing"}

Primary endpoints

• {"endpoint_text":"- Beck’s anxiety index between the first and second week.","definition_or_measurement_approach":"Not specified in the available data."}

Secondary endpoints

• {"endpoint_text":"- Effect of CBD on Fear extinction (i.e. physiological responses and subjective fear)","definition_or_measurement_approach":"Physiological responses and subjective fear (as stated in the endpoint)"}
• {"endpoint_text":"- Effect of CBD on stress regulation with the Maastricht Acute Stress Test (MAST; i.e. Subjective stress, physiological responses, alpha-amylase and cortisol)","definition_or_measurement_approach":"Measured with the Maastricht Acute Stress Test (MAST): subjective stress, physiological responses, alpha-amylase and cortisol (as stated)"}
• {"endpoint_text":"- Effect of CBD on Sleep quality (i.e. questionnaires and a sleep watch)","definition_or_measurement_approach":"Measured by questionnaires and a sleep watch (as stated)"}

Netherlands

Earliest CTIS Part Ii Submission Date

22-10-2024

Latest Decision Or Authorization Date

29-10-2024

Processing Time Days

7

Number Of Sites

1

Number Of Participants

82

Primary sponsor

Full Name

Universitair Medisch Centrum Utrecht

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Brain Research and Innovation Center, Ministry of Defense","duties_or_roles":"Source of monetary support","organisation_type":""}