dosage of cbd oil for chronic back pain

A Study of Cybis™ 10:25 THC:CBD Oil in Adults With Chronic Back/Neck Pain (CYDEPS)

This is a non-randomised, single arm, open-label study of Cybis™ 10:25 in participants with chronic back or neck pain in which participants receive escalating doses of Cybis™ 10:25.

The purpose of the study is to demonstrate the safety and tolerability of Cybis™ 10:25 in participants with moderate to severe chronic back or neck pain that is unresponsive to over-the-counter non-opioid analgesics.

Participants will undergo a screening visit, then seven clinic visits (Day 1, 2, 8, 15, 22, 29, and 35). Cybis™ 10:25 will be administered oromucosally at doses varying from 0.5 mL once daily to 1.5 mL twice daily. Total duration of dosing is 28 days.

Layout table for study information

Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dose-ranging Study to Examine the Pharmacokinetics, Safety, Tolerability and Efficacy of Cybis™ 10:25 THC:CBD Oil in Adults With Chronic Back/Neck Pain
Actual Study Start Date : September 20, 2021
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : April 30, 2022
    To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses. [ Time Frame: Safety and tolerability will be assessed throughout the trial. Up to 35 days. ]
    To investigate the pharmacokinetics of Cybis™ 10:25 in participants with chronic back and neck pain following single and repeated doses. Peak plasma concentration (Cmax) of THC in plasma. [ Time Frame: Up to 29 days. Samples collected at baseline 0 (pre-dose), 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 9.0, 12.0, and 24.0 hours post dosing. Day 8, 15, 22 and 29 trough levels. ]

To investigate the dose-response relationship between Cybis™ 10:25 and pain response as measured by the change from baseline in Numerical Pain Rating Scale (NPRS).

The NPRS is an 11-point scale between 0 (no pain) and 10 (worst pain ever possible). The minimum clinically significant change in NPRS is two points. The NPRS has been validated for use in participant with low back pain.

Baseline pain levels are considered the NPRS at Day 1, irrespective of dose cohort. Change from baseline will be calculated as the pain level at the end of a dose cohort (Day 8 for 0.5 mL once daily; Day 15 for 0.5 mL bd; Day 22 for 1.0 mL bd; or Day 29 for 1.5 mL bd) minus the Day 1 value.

To investigate the dose-response relationship between Cybis™ 10:25 and pain response as measured by the change from baseline in Brief Pain Inventory – Short Form.

The Brief Pain Inventory-Short Form is a questionnaire that assesses worst pain in the last 24 hours, least pain in the last 24 hours, average pain, and pain ‘right now’ along with the interference the pain causes on general activity, mood, walking ability, normal work, relations with others, sleep and enjoyment of life. It will be scored according to its scoring manual [24]. Scores will be summarised at baseline, Day 8, 15, 22, 29 and 35.

To investigate the dose-response relationship between Cybis™ 10:25 and quality of life as measured by the change from baseline in Depression Anxiety Stress Scale.

The Depression Anxiety Stress Scale (DASS) is a 21-item self-report instrument used to measure depression, anxiety and stress. The DASS will be scored according to its scoring manual. Participants will be categorised as having normal, mild, moderate, severe, or extremely severe symptoms. Lower scores indicate normal symptoms, whereas higher scores indicate severe symptoms.

Changes from baseline in DASS subscale scores will be used to investigate the dose-response relationship.

To investigate the dose-response relationship between Cybis™ 10:25 and quality of life as measured by the change from baseline in Medical Outcomes Sleep Survey.

The Medical Outcomes Sleep Scale is a 12-item scale that assesses sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. It will be scored according to its scoring manual.

The change in MOS Sleep Problems Index will be used to investigate the dose-response relationship.

To investigate the dose-response relationship between Cybis™ 10:25 and quality of life as measured by the change from baseline in in Self-Assessment of Treatment (SAT-II) scale.

The Self-Assessment of Treatment is a 9-item scale that measures treatment satisfaction in the previous seven days. It assesses pain, self-care activities, daily activities, physical activities, emotional well-being, sleep and social functioning, all assessed on a 5-point Likert scale. It also captures how likely the respondent would be willing to receive the study treatment again, and how study treatment compares to other treatments. The SAT-II has been validated, and is considered an acceptable endpoint for pain studies. The change in Self-Assessment of Treatment score will be used to investigate the dose-response relationship.

To investigate rescue medication use in participants prescribed Cybis™ 10:25 for chronic back and neck pain.

The proportion of patients requiring rescue medication and the number of doses of rescue medication required will be analysed descriptively. The time to first dose of rescue medication will be calculated using Kaplan-Meier methods.

CBD’s Role in Managing Pain

You’ve probably heard talk about CBD, or cannabidiol, if not tried it yourself for any number of conditions it is advertised to help. If you’re wondering what CBD is, if CBD helps control or lessen acute or chronic pain, and how to take or use CBD, you’ve come to the right place.

CBD is a chemical found in marijuana plants. This chemical does not contain the psychoactive ingredients also found in marijuana called THC, or tetrahydrocannabinol, therefore, CBD will not produce the “high” that most people associate with marijuana use. CBD mostly comes in an oil formulation, but it is also sold in extract, capsule, or a vaporized liquid format. If you do a Google search for CBD products for sale, you’d find most of your search inquiries are companies selling CBD infused beauty, food, and drink products. You’d also see that most of these companies advertise that their products can most remarkably help people with anxiety, depression, post-traumatic stress disorder, problems sleeping, and pain.

Can CBD really help reduce or manage pain? There have been studies that demonstrate that CBD may affectively alleviate pain by affecting the receptors of the endocannabinoid system, which is how the body regulates mood, memory, and most notably, pain. However, there are also many studies that are inconclusive on CBD’s effect on pain relief, and at the present time, the only form of CBD that is FDA approved is in a prescription oil called Epidiolex, which is approved to treat forms of Epilepsy. CBD is currently being studied not only for it’s potential to alleviate pain, but also to treat other conditions such as Parkinson’s, diabetes, multiple sclerosis, schizophrenia, anxiety, and many more. While empirical evidence is valued over anecdotal evidence in the medical community, it should at least be noted that there are thousands of people who claim that CBD products have helped greatly with their pain management. While the research and studies on CBD don’t yet exist to make the same claims, anyone who is wondering if CBD would work to help control their pain may want to consider that CBD has been effective in this arena for many people.

Though CBD isn’t FDA approved for pain management, the side effects are minimal enough to warrant giving CBD a try if you’re looking for a way to manage your pain outside of common prescription pain drugs. Most people tolerate CBD very well and experience little to no side effects. The few people that experience side effects from CBD use usually see these side effects in the form of dry mouth, diarrhea, reduced appetite, drowsiness, and fatigue. Medical professionals also caution people against potential negative reactions between CBD and other medications they are taking since there is not enough research on this aspect to state definitively that CBD does not react negatively with other medications.

If you’re going to give CBD a try, you’ll need to know how to take it or use it in your daily routine. CBD consumption can take place in a number of different ways, The most popular way to consume CBD is orally in the form of oil, capsules, or edible goods, but there are also many CBD products in the form of lotions, creams, oils, etc. that are used externally on your skin. As far as dosage, it’s recommended to start with a minimal dose and increase as needed. Proper dosage is dependent on many factors, including your weight, your individual body chemistry, what condition you’re trying to treat, and the concentration in the CBD formula you’re consuming. General recommendations say to start with 20-40 mg and increase by 5 mg a week until you feel that the CBD is effectively treating our condition. However, these are general guidelines and it’s always strongly recommended that you speak to your doctor for guidance on your personal CBD use and dosage.

What’s the bottom line when it comes to CBD and pain management? In a nutshell, CBD isn’t FDA approved for pain management, but it’s risks and side effects are so minimal, and so many people have stories about how well CBD has worked for them, that it may be worth a try- with the approval of your doctor. The medical community is looking forward to seeing what current and future research and studies on CBD will conclude, but in the present, CBD remains experimental and it’s positive effects are solely anecdotal.

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