This study has been transitioned to CTIS with ID 2024-514783-78-00 check the CTIS register for the current data. The aim of this project is to investigate CBD as a new medicine to target the ECS in the reduction of anxiety symptoms. Subsidiary aims…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters regarding the effects of CBD on anxiety symptoms are
measured PRE-waitlist, POST-waitlist and at 3 months FU.
Secondary outcome
Secondary parameters (effects on fear extinction and consolidation, and stress
regulation) are measured PRE and/or POST-waitlist. Sleep will be measured daily
during the waiting list period with an actiwatch. Further, blood will be
extracted PRE- and POST-waitlist in order to determine AEA, 2-AG and CBD
levels.
Background summary
Uniformed personnel display higher risks of anxiety symptoms due to increased
exposure to potential traumatic events. Those who seek help rarely receive
immediate access to treatment due to treatment waiting lists. Waiting lists
within mental health care institutes can reach 4 months, which might lead to
an increase of symptom severity and the need for more intense and longer
treatments.
The endocannabinoid system (ECS) plays a role in anxiety, but also in other
symptoms such as an enhanced stress reactivity and sleep difficulties.
Enhancement of the ECS with cannabidiol (CBD) as evidenced by increases of
endogenous cannabinoids anandamide (AEA) and 2-Arachidonoylglycerol (2-AG) may
help alleviate these symptoms in patients and prevent increase in symptom
severity in patients who are waiting for their treatment.
Study objective
This study has been transitioned to CTIS with ID 2024-514783-78-00 check the CTIS register for the current data.
The aim of this project is to investigate CBD as a new medicine to target the
ECS in the reduction of anxiety symptoms. Subsidiary aims of the project are to
investigate the effects of CBD on fear extinction and extinction consolidation,
stress regulation and sleep.
Study design
A clinical randomized placebo-controlled between-subjects trial in Dutch
uniformed personnel, amongst others (former) police officers, firefighters,
ambulance paramedics, military personnell or veterans.
Intervention
During a period of 2 weeks, before the start of the initial treatment,
participants of the study will receive either CBD (3 x 200 mg; oral capsules)
or matched placebo*s on a daily basis.
Study burden and risks
This study can make a contribution to a better understanding of the effects of
CBD on anxiety symptoms and corresponding relevant mechanisms. It is expected
that this study will bring little harm to patients since the risk for adverse
events to CBD are low. Occurrence of possible side effects will be closely
monitored. The main burden is that patients will be requested to invest time (a
total 7 hours, distributed over 3 days).
Lundlaan 1
Utrecht 3584 EZ
NL
Lundlaan 1
Utrecht 3584 EZ
NL
Listed location countries
Age
Inclusion criteria
• Dutch uniformed personnel (i.e. (former) police officers, firefighters,
ambulance paramedics, military personnel or veterans
• Age between 18-65
• Waiting for therapy for the treatment of a trauma and stressor-related and/or
an anxiety disorder
Exclusion criteria
• 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-514783-78-00 |
| EudraCT | EUCTR2020-003739-62-NL |
| CCMO | NL74835.041.21 |