This clinical trial is focused on studying the effects of a new treatment called VER-01 for patients suffering from chronic non-specific low back pain. This type of pain is persistent and occurs in the lower back without a clear specific cause. The trial aims to understand how different doses of VER-01, which is an oral solution containing dronabinol, can help reduce pain in these patients. The study will also involve a comparison with a placebo to evaluate the effectiveness of the treatment.
Participants in the trial will receive either the VER-01 treatment or a placebo over a period of several weeks. The study will monitor changes in pain levels and assess how the treatment affects the participants’ daily lives, including their sleep and overall well-being. The trial will also track any side effects or adverse reactions to ensure the safety of the treatment.
In addition to VER-01, the study will consider the effects of other medications like ibuprofen, paracetamol, and pantoprazole, which are commonly used for pain relief and other related conditions. The goal is to find the most effective dose of VER-01 that provides significant pain relief for patients who have not found sufficient relief from other non-opioid pain medications. The trial will last for several months, with regular check-ins to evaluate the progress and effectiveness of the treatment.
1initial visit
Upon joining the clinical trial, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as your age, medical history, and current health condition.
You will be asked to provide informed consent, which means you agree to participate in the study after understanding all the details and potential risks involved.
2baseline assessment
A baseline assessment will be conducted to evaluate your current level of pain using a numerical rating scale from 0 to 10. This will help in measuring changes in your pain levels throughout the trial.
You may also be asked to complete questionnaires about your pain and its impact on your daily life.
3treatment phase
During the treatment phase, you will receive the study medication, which could be the full-spectrum Cannabis Extract VER-01 or a placebo. The medication will be administered orally.
The dosage and frequency will be determined by the study protocol, and you will be required to take the medication as instructed for a period of 7 weeks.
4follow-up visits
You will attend regular follow-up visits to monitor your progress and any side effects. These visits are crucial for assessing the effectiveness of the treatment and ensuring your safety.
During these visits, your pain levels will be reassessed, and you may be asked to complete additional questionnaires.
5end of treatment phase
At the end of the 7-week treatment phase, a final assessment will be conducted to evaluate changes in your pain levels and overall health.
You will be asked to provide feedback on your experience during the trial, including any side effects or improvements in your condition.
6wash-out phase
After the treatment phase, there will be a wash-out phase where you will stop taking the study medication. This phase helps to observe any withdrawal symptoms and ensures that the medication is cleared from your system.
You may be asked to complete a questionnaire about any symptoms experienced during this phase.
Who Can Join the Study?
Patient has low back pain that fits into categories 1 to 3 according to the Quebec Task Force (QTF) classification system.
Patient is willing to avoid taking any prohibited medications during the trial. This includes not using additional pain relief medications (both non-opioid and opioid), except for emergency use. Certain medications that affect liver enzymes (CYP2C9 and CYP3A4) are also not allowed.
Patient is a male or female aged 18 years or older.
Patient has voluntarily signed and dated an informed consent form.
For women who can have children and men who can father children: Patient must use a reliable method of birth control starting at least 1 month before the trial, during the trial, and for 3 months after the last dose of the trial medication.
Patient understands the local language and is willing and able to attend scheduled visits, follow the treatment plan, use an electronic diary, and participate in other trial-related activities.
Patient has had chronic (lasting 3 months or more) non-specific pain in the lower back, which means pain without a clear specific cause like a herniated disk or infection.
Patient requires opioid drug treatment because previous treatments with non-opioid pain relievers did not provide enough relief or were not suitable due to side effects or other reasons.
Patient has experienced low back pain with an average intensity of 4 or more on a scale of 0 to 10 in the last 4 weeks before the first visit.
If the patient has been using non-drug therapies (like exercise, acupuncture, or massage) in the 4 weeks before the first visit, these therapies must have remained unchanged and should continue unchanged during the trial.
Who Cannot Join the Study?
Patients who have not experienced sufficient pain relief from previous treatments with non-opioid pain relievers or who cannot use them due to other health reasons.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
VER-01 is a full-spectrum cannabis extract being tested in this clinical trial. It is used to help reduce pain in patients who have chronic non-specific low back pain. This means that the pain is persistent and not caused by a specific condition or injury. The trial is looking to see how well different amounts of VER-01 can help in reducing pain for those who have not found relief with other non-opioid pain medications, or for whom those medications were not suitable due to side effects or other health reasons. The goal is to find out how effective VER-01 is in managing pain and to determine the best amount to use for treatment.
Chronic Non-Specific Low Back Pain – This condition is characterized by persistent pain in the lower back region that does not have a specific identifiable cause. It is termed “non-specific” because the pain is not attributed to any recognizable pathology such as a fracture, infection, or tumor. The pain can vary in intensity and may be accompanied by stiffness and reduced mobility. Over time, the pain may interfere with daily activities and sleep, leading to a decrease in quality of life. The progression of the condition can be influenced by factors such as physical activity, posture, and stress. It is a common condition that can affect individuals of all ages, but is more prevalent in adults.
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