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Study on the Effects of THC 2% Oil for Patients with Chronic Neuropathic Pain

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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 chronic neuropathic pain, a condition where people experience ongoing pain due to nerve damage. The treatment being tested is called Clinican THC 2% oil, which contains an active ingredient known as dronabinol. This study aims to understand how effective this oil is in reducing pain for individuals suffering from this type of chronic pain.

Participants in the study will receive either the Clinican THC 2% oil or a placebo, which looks like the treatment but does not contain the active ingredient. The study is designed to compare the effects of the oil with the placebo to see if there is a significant difference in pain relief. The study will also explore how different groups of patients respond to the treatment, which may help identify which patients benefit the most from the oil.

Throughout the study, participants will be asked to take the treatment under the tongue, a method known as sublingual use. The study will last for a period of time, during which participants will regularly report their pain levels and other experiences. This information will help researchers determine the effectiveness of the treatment and gather insights into its impact on quality of life, sleep, anxiety, and other factors related to chronic neuropathic pain.

The research process

The trial runs in 6 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 asked to provide your signed informed consent. This means you agree to participate in the study after understanding all the details and requirements.
You will need to confirm that you are 18 years or older and have been experiencing chronic neuropathic pain for at least 3 months with a pain score greater than 4 on a numeric rating scale.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your pain levels and other health parameters. This may include completing questionnaires about your pain, sleep quality, anxiety, and depression.
Your ability to communicate in Dutch and willingness to comply with study restrictions will also be assessed.
Step 3
Treatment phase 1
You will receive either the Clinican THC 2% oil or a placebo for sublingual use. Sublingual use means placing the oil under your tongue.
The dosage and frequency of administration will be explained to you by the study team. This phase will last for a specified period, during which you will be required to record your pain levels daily.
Step 4
Crossover phase
After completing the first treatment phase, there will be a crossover to the other treatment. If you initially received the THC oil, you will now receive the placebo, and vice versa.
This phase will also last for a specified period, and you will continue to record your pain levels daily.
Step 5
Ongoing assessments
Throughout the study, you will undergo regular assessments to monitor your pain severity, sleep quality, anxiety, depression, and overall quality of life.
You will also be asked about any side effects or other medications you are taking.
Step 6
Study completion
At the end of the study, a final assessment will be conducted to evaluate the overall effects of the treatment on your chronic neuropathic pain.
You will be asked to return any unused medication and provide feedback on your experience during the study.

Who can join the trial?

5 criteria

Must provide a signed informed consent before any study-related procedures begin.
Must be a male or female aged 18 years or older.
Must have had chronic neuropathic pain for at least 3 months. This is a type of pain caused by nerve damage. The pain must be rated higher than 4 on a scale from 0 to 10, where 10 is the worst pain imaginable.
Must have a score of 4 or higher on the Douleur Neuropathic 4 (DN4) questionnaire. This is a tool used to identify neuropathic pain.
Must be able to communicate well with the study team in Dutch and be willing to follow the study rules.

Who cannot join the trial?

10 criteria

Patients who are not experiencing chronic neuropathic pain cannot participate. This type of pain is caused by damage to the nerves and lasts for a long time.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. The study is designed for specific groups of people.
Patients who are not willing to follow the study procedures and requirements cannot participate.
Patients who have certain medical conditions that might interfere with the study cannot participate. These conditions will be assessed by the study team.
Patients who are taking medications that might interfere with the study cannot participate. The study team will review current medications.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of substance abuse or addiction cannot participate.
Patients who have participated in another clinical trial recently cannot participate.
Patients who have allergies to the study medication or its ingredients cannot participate.

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Academisch Ziekenhuis Leiden
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Leiden, The Netherlands

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Investigated drugs

THC 2% oil is a treatment being studied for its potential to relieve chronic neuropathic pain. THC, or tetrahydrocannabinol, is a compound found in cannabis plants. In this trial, it is used in the form of an oil that contains 2% THC. The goal is to see if this oil can help reduce pain in people who suffer from long-term nerve pain. Researchers are also interested in understanding if certain groups of patients respond better to this treatment than others. This study aims to find out how effective THC oil is in managing pain and to identify which patients might benefit the most from it.

Dronabinol

What is already known about the treatment

THC 2% oil – This medication is administered as an oil, typically applied under the tongue for absorption. It is currently being studied in clinical trials for its potential to relieve chronic neuropathic pain, a condition characterized by persistent nerve pain. THC, or tetrahydrocannabinol, works by interacting with the body's endocannabinoid system, which plays a role in regulating pain and inflammation. It is classified as a cannabinoid, a type of compound found in cannabis plants.

Investigated diseases

Chronic Neuropathic Pain – Chronic neuropathic pain is a persistent pain condition resulting from damage or dysfunction in the nervous system. It is characterized by sensations such as burning, tingling, or shooting pain, often occurring without an obvious cause. This type of pain can arise from various conditions, including diabetes, shingles, or nerve injuries. Over time, the pain may become more intense and widespread, affecting daily activities and quality of life. The progression of chronic neuropathic pain can lead to increased sensitivity to stimuli, where even light touch or temperature changes can cause significant discomfort. It often requires ongoing management to help alleviate symptoms and improve function.