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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 below
Select...
I have been experiencing moderate to severe pain for at least 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks for reporting.

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 more

Trial 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
831 Previous Clinical Trials
668,767 Total Patients Enrolled
8 Trials studying Multiple Sclerosis
197 Patients Enrolled for Multiple Sclerosis
Tiffany BraleyPrincipal InvestigatorUniversity of Michigan

Media Library

Cannabidiol (CBD) (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05269628 — Phase 2
Multiple Sclerosis Research Study Groups: Cannabidiol (CBD), Tetrahydrocannabinol (THC), CBD + THC, Placebo CBD + Placebo THC
Multiple Sclerosis Clinical Trial 2023: Cannabidiol (CBD) Highlights & Side Effects. Trial Name: NCT05269628 — Phase 2
Cannabidiol (CBD) (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05269628 — Phase 2

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
~83 spots leftby Jun 2026