Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Multicenter, double-blind, randomized, placebo-controlled, dose-response trial with the full-spectrum Cannabis Extract VER-01 in patients with chronic non-specific low back pain

This study is looking into a new cannabis-based medicine called VER-01 for people who suffer from long-term lower back pain. We're interested in those whose pain hasn't improved enough with standard non-opioid pain relief, or who can't take those medicines. The main goal is to see if VER-01 can reduce back pain more effectively than a dummy pill (placebo). Participants will be given either VER-01 or a placebo, alongside common pain medications like paracetamol or ibuprofen if needed. We'll be carefully tracking pain levels, sleep quality, and any side effects. This is an early-stage study (Phase II) to help us understand the right dose and how well it works before larger studies. It's designed to be safe and help us learn more about treating persistent back pain.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Vertanical GmbH

Enrolment target

767

Start

12 Jan 2024

What is this study about?

This study is designed to explore a new potential treatment for people with ongoing lower back pain. Many people live with this kind of pain, and sometimes common pain relievers don't offer enough relief, or they can't be used due to other health reasons. This study is testing a new medicine called VER-01, which is a full-spectrum cannabis extract. It's hoped that VER-01 might offer a new option for managing this kind of pain.

The main aim of the study is to see if VER-01 can reduce your pain more than a dummy pill (called a placebo). A placebo looks exactly like the study medicine but doesn't contain any active drug. This helps researchers work out if any changes in pain are truly from the new medicine or just from other factors. We'll be measuring your pain levels using a simple scale before you start treatment and again after about seven weeks to see if there's a difference. We'll also look at how pain affects your sleep and your overall feeling of improvement.

Alongside checking pain, we will also very carefully monitor your safety. This includes looking out for any side effects you might experience. We will also check if the medicine affects your sleep in a positive way, how satisfied you are with the treatment, and if there are any signs of addiction or withdrawal symptoms when the treatment stops. This in-depth look helps us understand if VER-01 is not only effective but also safe and well-tolerated for people with chronic lower back pain.

Key takeaways

Tests a new cannabis-based medicine (VER-01) for long-term back pain.
Compares VER-01 to a dummy pill (placebo) to see if it reduces pain.
Aims to find out if VER-01 is safe and effective.
Suitable for adults whose pain hasn't improved with other non-opioid medicines.
Participation involves regular clinic visits for monitoring and questionnaires.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 years or older. The study is open to both men and women.

The most important requirement is that you have ongoing lower back pain that isn't caused by a specific disease, injury, or nerve problem, but is more general and long-lasting. You must have tried standard pain medicines that don't contain strong opioids (like paracetamol or ibuprofen) and found they either haven't helped enough or you couldn't take them due to side effects or other health reasons.

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.

Are you 18 years old or older?
Do you have chronic (long-lasting) lower back pain?
Has your back pain not been caused by a specific injury or condition?
Have standard non-opioid pain medicines not helped your pain enough, or can you not take them?
Are you willing to attend regular clinic visits?

Answer every question to see your result.

What does participation involve?

If you join this study, your journey will involve a few stages over several weeks. You will be randomly assigned to receive either the active study medicine (VER-01) or a placebo (a dummy pill). You and your study doctor won't know which one you're taking, which is called 'double-blind'.

You'll have regular visits to the study clinic where doctors and nurses will monitor your health, pain levels, and any side effects. You'll complete questionnaires about your pain, sleep, and overall well-being. You might also be given standard pain relief like paracetamol or ibuprofen to take if needed, and we'll keep track of how much you use.

The main treatment phase lasts for about seven weeks. Before this, there will be an initial assessment week, and afterwards, there's a period where you'll stop taking the study medicine so we can see how your body reacts. Throughout the study, we'll collect information to understand how the medicine works and if it's safe. The total duration of your involvement will be confirmed by the study team, typically spanning a few months from start to finish.

Potential risks and benefits

Taking part in this study could potentially offer you a new way to manage your ongoing lower back pain, especially if other treatments haven't worked. You might experience a reduction in your pain levels and an improvement in your sleep. However, there's no guarantee that you will receive the active medication or that it will help your pain. Like all medicines, VER-01 could have side effects, which the study team will monitor closely. These will be fully explained before you decide to join. There might also be a small risk related to study procedures, like blood tests. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Germany
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Unverified
Czechia
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Unverified
Spain
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Unverified
Poland

Common questions

What is 'chronic non-specific low back pain'?

It means long-lasting lower back pain that isn't linked to a known cause like a fracture, infection, or specific nerve damage. It's very common.

What does 'placebo-controlled' mean?

Some people in the study will get the new medicine, and others will get a 'dummy pill' (placebo) that looks the same but has no active ingredient. This helps us see if the new medicine really works better than no treatment.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor the study doctor will know. This is called 'double-blind' and is a standard way to ensure fair results.

What are 'rescue medications'?

These are extra pain relievers, like paracetamol or ibuprofen, that you can take if your study medication isn't fully controlling your pain. We track how much you use.

What is a 'Phase II' clinical trial?

This is an early stage of testing where we look at the safety of the new medicine and see if it has a positive effect on the condition. We also try to find the best dose to use in later, larger studies.