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Cannabinoid

CBD for Chronic Low Back Pain (CBD Trial)

Phase 2
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Average worst daily pain of at least 4 on a 0-10 scale of pain intensity, present for at least 50% of days during a typical week
High or mixed affinity binding to [11C]PBR28 identified by the Ala147Thr TSPO polymorphism in the TSPO gene (rs6971)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from average score of the 7 days prior to initiation of treatment to average score of the 7 days of week 4
Awards & highlights

CBD Trial Summary

This trial will study whether CBD, a non-intoxicating compound found in cannabis, can help relieve chronic low back pain and depression.

Who is the study for?
This trial is for English-speaking adults aged 18-75 with chronic low back pain lasting at least 6 months, experiencing significant daily pain. Participants must be on stable pain treatment and not using high opioid doses, recreational drugs, or have certain medical conditions like major cardiac events in the past decade.Check my eligibility
What is being tested?
The study tests if CBD can reduce brain inflammation in patients with chronic low back pain, with or without mild-to-moderate depression. It compares the effects of CBD against a placebo to see if it helps manage their condition.See study design
What are the potential side effects?
Potential side effects may include allergic reactions due to sesame oil in Epidiolex (a form of CBD), liver enzyme elevations especially when combined with valproate and clobazam, and possibly other unknown risks associated with CBD.

CBD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My worst daily pain is at least a 4 on a scale of 0-10, and it happens most days of the week.
Select...
My genetic test shows I have a specific marker (Ala147Thr) for a study.
Select...
I am between 18 and 75 years old.

CBD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from average score of the 7 days prior to initiation of treatment to average score of the 7 days of week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from average score of the 7 days prior to initiation of treatment to average score of the 7 days of week 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Neuroinflammation in the Thalamus
Secondary outcome measures
Change in Clinical Pain Ratings
Change in Depressive Symptoms
Change in Pain Bothersomeness
+4 more
Other outcome measures
Change in Depression [Exploratory]
Change in Disability Related to Low Back Pain [Exploratory]
Change in Functional Brain Reward Circuitry [Exploratory]
+8 more

Side effects data

From 2014 Phase 2 trial • 50 Patients • NCT01844687
2%
headache
2%
Blurred Vision
2%
Cold Symptoms
2%
Gastrointestinal Upset
2%
anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active MJ With 0 mg CBD
Active MJ With 200 mg CBD
Active MJ With 400 mg CBD
Active MJ With 800 mg CBD
Inactive MJ With 0 mg CBD
Inactive MJ With 200 mg CBD
Inactive MJ With 400 mg CBD
Inactive MJ With 800 mg CBD

CBD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cannabidiol (CBD)Experimental Treatment1 Intervention
The recommended starting dosage is 2.5mg/kg taken twice daily. The titration schedule recommended in the EPIDIOLEX label will be followed, with 2.5 mg/kg twice daily in week 1, 5 mg/kg twice daily in week 2, 7.5 mg/kg twice daily in week 3, and 10 mg/kg twice daily in week 4 with the second PET scan conducted after one week at the maximum labeled dose. Any participant not tolerating a given dose can either go back down to the next lowest dose or delay uptitration at any week in the protocol. Participants will be instructed to take Epidiolex with a meal rather than in a fasted state. Participants will be treated for 4 weeks in total.
Group II: PlaceboPlacebo Group1 Intervention
The placebo will be taken at identical doses to the active drug condition.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CBD
2016
Completed Phase 2
~460

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,946 Previous Clinical Trials
13,204,544 Total Patients Enrolled
9 Trials studying Back Pain
1,075 Patients Enrolled for Back Pain

Media Library

Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05066308 — Phase 2
~38 spots leftby Sep 2026
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