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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

Must not have

Current severe depression as indicated by a PHQ-9 score of ≥ 17 that includes indicators of significant depressed mood (sum of items #1 and #2 ≥ 5)

Current warfarin, valproate or clobazam use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently experiencing severe depression.

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I am currently taking warfarin, valproate, or clobazam.

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I've had car accidents or close calls because of untreated sleepiness in the last 6 months.

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My blood pressure is not between 90/60 and 180/120 mmHg, or I have fainted due to a sudden drop in blood pressure.

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I experience pain because of my cancer.

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I have had serious heart issues, like a recent heart attack or severe heart failure, in the last 6 months.

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My disability level is significant, needing assistance for most daily activities.

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I work as a commercial driver or in a job involving extreme heights or heavy machinery.

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I am allergic to cannabinoids, Epidiolex®, Dronabinol, or sesame oil.

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I have a history of seizures or head injuries that could increase my risk of seizures.

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I am currently using opioids, but tramadol is okay.

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I have been diagnosed with a sleep disorder through sleep studies.

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My liver function tests are within required limits.

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I am not taking any strong medication that affects liver enzymes or has a narrow safety range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Transition Entropy

Change in Walsh Spectral Entropy

Change in sleep continuity and duration

+4 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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

0 / 15Eligibility criteria met