Not recruiting

Study on Cannabidiol for Reducing Anxiety and PTSD Symptoms in Dutch Uniformed Personnel

Verified siteInvestigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for individuals experiencing symptoms of anxiety disorders and Post-Traumatic Stress Disorder (PTSD). The treatment being tested is a substance called Cannabidiol (CBD), which is a chemical compound found in cannabis plants. In this study, CBD is administered in the form of capsules. The purpose of the study is to explore how a two-week course of CBD might help reduce anxiety symptoms before starting therapy for anxiety or PTSD.

The study involves participants who are Dutch uniformed personnel, such as police officers, firefighters, ambulance paramedics, military personnel, or veterans. Participants will take CBD capsules daily for two weeks. During this period, researchers will monitor changes in anxiety levels using a tool called Beck’s anxiety index. Additionally, the study will assess how CBD affects fear responses, stress regulation, and sleep quality. These assessments will involve questionnaires, physiological measurements, and a sleep watch to gather comprehensive data on the effects of CBD.

By examining these factors, the study aims to provide insights into whether CBD can be beneficial in managing anxiety symptoms and improving overall well-being before starting traditional therapy for anxiety or PTSD. The findings could potentially lead to new approaches in preparing individuals for therapy, enhancing their treatment outcomes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the purpose and procedures of the trial. You will be asked to provide consent to participate.
You will be assessed to ensure you meet the criteria for participation, which includes being a member of the Dutch uniformed personnel, aged between 18-65, and waiting for therapy for trauma or anxiety-related disorders.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your anxiety levels using Beck's anxiety index. This will help establish a baseline for your anxiety symptoms.
Step 3
Medication administration
You will begin a 2-week course of cannabidiol (CBD) treatment. The medication will be provided in the form of capsules, taken orally.
The dosage and frequency of the CBD capsules will be explained to you by the study team. It is important to follow the instructions carefully for the duration of the 2-week period.
Step 4
Weekly assessments
During the 2-week period, your anxiety levels will be monitored weekly using Beck's anxiety index to observe any changes.
Additional assessments will be conducted to evaluate the effects of CBD on fear responses, stress regulation, and sleep quality. These may include questionnaires, physiological measurements, and the use of a sleep watch.
Step 5
Completion of trial
At the end of the 2-week period, a final assessment will be conducted to evaluate the overall effects of the CBD treatment on your anxiety symptoms.
You will be provided with information on the next steps and any follow-up that may be required.

Who can join the trial?

3 criteria

Must be a member of the Dutch uniformed personnel, such as (former) police officers, firefighters, ambulance paramedics, military personnel, or veterans.
Must be between the ages of 18 and 65.
Must be waiting for therapy to treat a trauma and stressor-related disorder or an anxiety disorder. This is determined by a psychiatric interview called the MINI PLUS.

Who cannot join the trial?

4 criteria

People with certain psychological disorders such as PTSD (Post-Traumatic Stress Disorder) or anxiety disorders cannot participate.
Individuals who are not within the specified age range for the study.
Participants who do not belong to the specified clinical trial groups.
Individuals who are considered part of a vulnerable population, which means they might need special protection or care, are not eligible.

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Universitair Medisch Centrum Utrecht
Responsive
Utrecht, The Netherlands

Trial locations

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Investigated drugs

Cannabidiol (CBD) is a natural compound found in the cannabis plant. It is often used for its potential calming effects and is being studied for its ability to help reduce anxiety symptoms. In this clinical trial, CBD is being given to participants for two weeks to see if it can help ease anxiety symptoms before they start other treatments for anxiety or PTSD. The goal is to see if CBD can make these symptoms more manageable for people who work in high-stress jobs, like those in uniformed services in the Netherlands.

Cannabidiol

What is already known about the treatment

Cannabidiol (CBD) – Cannabidiol, commonly known as CBD, is administered orally, often in the form of oils, capsules, or edibles. It is currently being studied for its potential benefits in treating psychological disorders such as PTSD and anxiety disorders. The main therapeutic indication for CBD in this context is to alleviate anxiety symptoms, particularly in individuals undergoing treatment for anxiety or PTSD. At the molecular level, CBD interacts with the body's endocannabinoid system, which plays a role in regulating mood and stress responses. It is classified pharmacologically as a cannabinoid, a type of compound found in cannabis plants.

Investigated diseases

Post-Traumatic Stress Disorder (PTSD)
PTSD is a psychological disorder that can develop after experiencing or witnessing a traumatic event. It is characterized by persistent and intrusive memories of the trauma, which can lead to severe emotional distress. Individuals with PTSD may experience flashbacks, nightmares, and severe anxiety. They often avoid situations or stimuli that remind them of the traumatic event. Over time, PTSD can lead to changes in mood and cognition, including feelings of detachment and negative thoughts about oneself or the world. The disorder can also cause heightened arousal responses, such as being easily startled or having difficulty sleeping.
Anxiety Disorders
Anxiety disorders encompass a range of mental health conditions characterized by excessive fear or worry. These disorders can manifest as generalized anxiety disorder, panic disorder, social anxiety disorder, and specific phobias, among others. Individuals with anxiety disorders often experience intense, prolonged feelings of nervousness or dread. Physical symptoms may include increased heart rate, sweating, trembling, and fatigue. Anxiety disorders can interfere with daily activities and relationships, as the fear or worry can be overwhelming and difficult to control. The progression of these disorders varies, with symptoms potentially fluctuating in intensity over time.