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THC for chronic neuropathic pain
EU CTIS ID: 2022-502343-35-00
What this study is testing
To investigate the analgesic effects of THC 2% oil in patients with chronic neuropathic pain. To investigate the difference in analgesic effects of THC 2% oil between phenotypical subgroups of patients with chronic neuropathic pain as defined by QST.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Signed informed consent prior to any study-mandated procedure
- 2. Male or female subjects aged 18 years or older, inclusive at screening.
- 4. Presence of any chronic (at least 3 months) neuropathic pain with a numeric rating scale (NRS) > 4, disregarding etiology. Possible etiologies include, but are not restricted to: a. Peripheral neuropathic pain syndromes (e.g., painful (diabetic) polyneuropathy, , peripheral nerve injury pain, postamputation pain and persisting post-radiculopathy pain without evidence of current root compression); b. Central neuropathic pain syndromes (e.g., neuropathic pain associated with spinal injury, central poststroke pain, central neuropathic pain associated with multiple sclerosis); c. Complex regional pain syndrome type 2 (with evidence of nerve damage).
- 5. Score of ≥4 on the Douleur Neuropathic 4 (DN4) questionnaire.
- 7. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
You likely can't join if
- 1. Evidence of any active or chronic disease or condition that is likely to interfere with, or for which the treatment is likely to interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead electrocardiogram (ECG)). Deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.
- 5. History of alcohol or substance use disorder or current use of more than 21 units of alcohol per week, or regular unprescribed use of sedatives, hypnotics, tranquilizers, or other addictive agents such as cocaine and non-prescribed amphetamines. The use of controlled substances, for example pain or sleep medication, will be allowed if prescribed by a registered physician. Documentation must be provided to confirm this.
- 6. Current or recent (<4 weeks prior to screening) recreational or medicinal use of cannabis.
- 10. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or current psychiatric disease.
- 11. History of cannabis-induced psychosis, schizophrenia or other clinically relevant psychiatric disorders, as judged by the investigator.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.