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RecruitingTherapeutic exploratory (Phase II)Interventional

BOOSTCAMP - Boosting the endocannabinoid system before the treatment of anxiety symptoms

Anxiety disorders and post-traumatic stress disorder (PTSD) can be challenging to live with and treat. The BOOSTCAMP clinical trial is exploring whether cannabidiol (CBD) can help calm the body's stress response before standard anxiety treatment begins. CBD is a natural compound found in cannabis plants, but unlike THC, it does not cause a 'high'. In this Phase II study, adults experiencing anxiety or PTSD will take either CBD or an inactive matching substance (a placebo) for two weeks. Researchers will measure anxiety levels using standard symptom questionnaires at the end of the first and second weeks. They will also look at how CBD affects sleep quality using a wearable sleep tracker, and check how the body handles stress by measuring stress hormones in saliva. The goal is to see if CBD can prepare the mind and body for better recovery.

At a glance

Status
Recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Universitair Medisch Centrum Utrecht
Enrolment target
82
Start
29 Oct 2024

What is this study about?

Living with severe anxiety or post-traumatic stress disorder (PTSD) can make everyday life feel exhausting. Common symptoms include constant worry, panic, poor sleep, and physical tension. While talking therapies and existing medicines can be very helpful, they do not work for everyone, and finding relief can take a long time. Researchers are searching for new, gentle ways to help the brain and body respond better to anxiety care.

This trial focuses on the body's 'endocannabinoid system'. This is an internal network of chemical signals that naturally helps balance our mood, stress levels, fear, and sleep patterns. The study tests whether giving cannabidiol (CBD) can support this system. CBD is an active part of the cannabis plant that has calming properties without being addictive or causing any intoxicating effects.

During the study, researchers will assess whether CBD helps reduce overall anxiety scores over two weeks. They will also check if it helps people let go of fearful memories, stay calmer during brief stress tests, and enjoy deeper, more restful sleep.

If the trial shows positive results, CBD could become a helpful tool used alongside existing treatments to help people feel calmer and get more benefit from therapy.

Key takeaways

  • Tests whether cannabidiol (CBD) helps reduce anxiety and PTSD symptoms over two weeks.
  • Open to adults aged 18 and over with anxiety disorders or PTSD.
  • Involves taking either CBD or a placebo and filling out questionnaires.
  • Checks how your body responds to stress and tracks your sleep with a wrist device.
  • Taking part is completely voluntary and will not affect your usual NHS treatment.

Who may be eligible?

This study is open to adults aged 18 and older who are experiencing symptoms of an anxiety disorder or post-traumatic stress disorder (PTSD). Both men and women can take part.

Because this is an early-stage study, the research team will check your medical history to make sure it is safe for you to join. People who are pregnant, breastfeeding, or taking certain medicines that could interact with CBD may not be able to participate.

A doctor or research nurse from the study team will speak with you directly to review your symptoms and confirm whether the trial is a good and safe match for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you aged 18 or over?
  2. Do you have a diagnosis of, or ongoing symptoms of, an anxiety disorder or PTSD?
  3. Are you able to take study medication daily for two weeks?
  4. Are you willing to complete mood questionnaires and wear a sleep tracker?
  5. Are you currently not pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given either CBD or an inactive comparison substance (placebo) to take for two weeks. You will have clinic appointments where the research team will check on your health and ask you to fill in simple questionnaires about your anxiety levels.

You will also take part in tests to see how your body handles stress. This includes giving small saliva samples so the team can measure natural stress hormones such as cortisol. In addition, you will be given a comfortable sleep watch (similar to a fitness tracker) to wear at home so researchers can monitor your sleep quality. The entire study lasts only a few weeks, and the research team will support you throughout.

Potential risks and benefits

Taking part might help you understand your anxiety better, and some people may notice an improvement in their stress or sleep, although benefits cannot be guaranteed. CBD is generally well tolerated, but it can sometimes cause mild side effects such as tiredness, dry mouth, changes in appetite, or an upset stomach. The stress tests might also cause brief, temporary discomfort. Taking part is entirely voluntary, and you are free to leave the study at any time without giving a reason and without affecting your normal NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    Netherlands

Common questions

Will taking CBD make me feel high?

No. CBD does not contain the substance (THC) that causes a 'high', and it is not addictive.

What is a placebo?

A placebo is a dummy treatment that looks and tastes like the real study drug but contains no active medicine. It helps researchers see if the real medicine actually works.

Do I have to pay to take part?

No. You will never be asked to pay to take part in a clinical trial, and the study medication is provided free of charge.

What is the sleep watch used for?

It is a small, lightweight device worn on your wrist that measures your movement during the night to help researchers understand how well you are sleeping.

Can I leave the study if I change my mind?

Yes. You can leave the trial at any point without needing to explain why, and it will not affect your standard medical care in any way.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "BOOSTCAMP - Boosting the endocannabinoid system before the t…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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