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Cannabinoid
CBD + THC for Multiple Sclerosis Symptoms
Phase 2
Recruiting
Led By Tiffany Braley
Research Sponsored by Tiffany J. Braley, MD, MS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of chronic pain defined as moderate to severe pain for at least 3 months, based on a 0-10 numeric rating scale (NRS)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks
Awards & highlights
Study Summary
This trial will study whether CBD, THC, or a combination of the two can improve sleep and reduce pain in people with MS.
Who is the study for?
This trial is for people with multiple sclerosis (MS) who have had moderate to severe chronic pain for at least 3 months. They must be on a stable MS medication without liver issues and agree to keep their pain treatment the same during the study. People can't join if they use certain drugs, have serious heart problems, are pregnant or breastfeeding, have a history of drug abuse or certain mental health conditions, or work in jobs that require alertness.Check my eligibility
What is being tested?
The study tests how CBD and THC affect sleep and pain in MS patients. Participants will receive either CBD, THC, both, or placebos to see if these substances improve sleep quality and reduce pain levels.See study design
What are the potential side effects?
CBD and THC may cause drowsiness, changes in appetite or mood swings. Some might experience dry mouth or dizziness. Side effects vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been experiencing moderate to severe pain for at least 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Transition Entropy
Change in Walsh Spectral Entropy
Change in sleep continuity and duration
+4 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Cannabidiol (CBD)Experimental Treatment2 Interventions
Epidiolex® doses will be 0.5 mL twice daily during the first seven days of active treatment and 1 mL twice daily (b.i.d.) for the remaining days of treatment.
PLUS Placebo Tetrahydrocannabinol (TCH) capsules which contain no active ingredients. Matching placebo capsules will be taken twice per day in the same schedule and manner as active dronabinol.
Group II: Tetrahydrocannabinol (THC)Active Control2 Interventions
The drug dose will be 2.5 mg b.i.d. during the first seven days of active treatment, and 5 mg b.i.d. for the following days of active treatment.
PLUS Placebo CBD (A matching placebo oral solution to Epidiolex® will be used that consists of all of the excipients in the active solution without the cannabidiol component). The placebo will be dosed in the same schedule and manner as active Epidiolex®.
Group III: CBD + THCActive Control2 Interventions
Epidiolex® (CBD) doses will be 0.5 mL twice daily during the first seven days of active treatment and 1 mL twice daily (b.i.d.) for the remaining days of treatment.
The THC dose will be 2.5 mg b.i.d. during the first seven days of active treatment, and 5 mg b.i.d. for the following days of active treatment.
Group IV: Placebo CBD + Placebo THCPlacebo Group2 Interventions
Placebo CBD (A matching placebo oral solution to Epidiolex® will be used that consists of all of the excipients in the active solution without the cannabidiol component). The placebo will be dosed in the same schedule and manner as the active CBD.
Placebo Tetrahydrocannabinol (TCH) capsules which contain no active ingredients. Matching placebo capsules will be taken twice per day in the same schedule and manner as active drug.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
FDA approved
Find a Location
Who is running the clinical trial?
Tiffany J. Braley, MD, MSLead Sponsor
National Center for Complementary and Integrative Health (NCCIH)NIH
832 Previous Clinical Trials
668,807 Total Patients Enrolled
8 Trials studying Multiple Sclerosis
197 Patients Enrolled for Multiple Sclerosis
Tiffany BraleyPrincipal InvestigatorUniversity of Michigan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have MS and have been on a stable medication dose for 3+ months without liver issues.I have multiple sclerosis and have been on a stable medication dose for 3+ months without liver issues.I don't have any health conditions that could risk my safety in the trial.I am currently experiencing severe depression.I am not currently using any strong CYP2C19 drugs, except for certain allowed medications.I am currently taking warfarin, valproate, or clobazam.I've had car accidents or close calls because of untreated sleepiness in the last 6 months.My blood pressure is not between 90/60 and 180/120 mmHg, or I have fainted due to a sudden drop in blood pressure.I experience pain because of my cancer.I have had serious heart issues, like a recent heart attack or severe heart failure, in the last 6 months.I am not using any strong medications that affect liver enzymes, except for short treatments with certain exceptions.My disability level is significant, needing assistance for most daily activities.I work as a commercial driver or in a job involving extreme heights or heavy machinery.I am allergic to cannabinoids, Epidiolex®, Dronabinol, or sesame oil.I have a history of seizures or head injuries that could increase my risk of seizures.I haven't had an MS flare-up in the last 30 days.I am currently using opioids, but tramadol is okay.I have been experiencing moderate to severe pain for at least 3 months.I have been diagnosed with a sleep disorder through sleep studies.My liver function tests are within required limits.I am not taking any strong CYP3A4 or CYP2C19 inducers, except for allowed medications like glucocorticoids or modafinil/armodafinil.I am not taking any strong medication that affects liver enzymes or has a narrow safety range.I have been in moderate to severe pain for at least 3 months.You are willing to maintain stable analgesic regimen during study period.You need to have had a blood test for liver function within the last 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: Cannabidiol (CBD)
- Group 2: Tetrahydrocannabinol (THC)
- Group 3: CBD + THC
- Group 4: Placebo CBD + Placebo THC
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Which patients does this trial seek to enroll?
"This particular clinical trial is testing a new pain medication and is currently looking for 166 participants that aged 18 to 65 years old."
Answered by AI
Will this research be inclusive of elderly patients?
"The age range for eligible patients in this study are individuals who are over 18 but under 65 years old."
Answered by AI
Does this trial currently have any open slots for new participants?
"That is correct, the trial is still recruiting participants. According to the most recent update on clinicaltrials.gov, which was posted on 3/31/2022, this study is looking for 166 individuals at a single site."
Answered by AI
Is there a potential for CBD to be harmful for patients?
"While there is some evidence supporting CBD's safety, it remains unproven whether or not it is an effective medication. For this reason, Power has given it a rating of 2."
Answered by AI
How many people are joining this clinical trial?
"The trial is still looking for enrollees, with the most recent update to the listing on clinicaltrials.gov being on March 31st, 2022. The posting went up on March 25th of the same year and 166 patients are needed from 1 medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
University of Michigan
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