PTSD and anxiety disorders
Conditions
Interventions
Product Name: Cannabidiol (CBD)
Pharmaceutical Form: Capsule
INN or Proposed INN: Cannabidiol
CAS Number: 13956-29-1
Other descriptive name: CANNABIDIOL
Concentration unit: mg milligram(s)
Concentrati
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Dutch military personnel or veteran • Age between 18-65 • Waiting for therapy for the treatment of PTSD and/or anxiety disorders Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 82 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Severe co-morbidity (severe major depressive or bipolar disorder and/or psychosis) • Alcohol and/or drug dependence • Inability to adequately read or speak Dutch • (a history of) epilepsy or brain damage, cardiac, renal or liver abnormalities • (a history of) allergies to medication (adverse reactions or rash) • 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) • Used cannabis, synthetic cannabinoid, cannabinoid analogue, or any CBD or THC-containing product within 30 days of eligibility screening. • Individuals that had been diagnosed with intestinal, liver, or renal diseases that would affect absorption or clearance of CBD • For women: pregnant, a wish to become pregnant, or nursing
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The effect of CBD on fear extinction and consolidation - This will be measured pre and post waitlist - Parameters are subjective fear and expectancy, skin conductance response and startle response The effect of CBD on stress regulation - This will be measured post waitlist - Parameters are subjective stress, skin conductance, cortisol response and heart rate. The effect of CBD on sleep - This will be measured subjectively pre and post waitlist - This will be measured objectively with a actiwatch during the weeks of CBD administration ;Secondary end point(s): The secondary endpoint of the study are: - The effect of CBD on fear extinction and consolidation - The effect of CBD on stress regulation - The effect of CBD on sleep | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this project is to investigate CBD as a new medicine to target the ECS in the reduction of anxiety symptoms. ;Secondary Objective: Subsidiary aims of the project are to investigate the effects of CBD on fear extinction and extinction consolidation, stress regulation and sleep. ;Primary end point(s): The primary endpoint of the study is the effects of CBD on anxiety symptoms as measured with the Beck Anxiety Inventory (BAI).;Timepoint(s) of evaluation of this end point: This will be measured pre waitlist, 1 week after CBD administration, post waitlist and at 3 month follow up. For the main analysis we compare the pre and post waitlist score on anxiety symptoms. | — |
Countries
Netherlands
Contacts
Public ContactElbert Geuze
The Brain Research and Innovation Centre / University Medical Center Utrecht
Outcome results
None listed