← Back to Search

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)

Must not have

Current bacterial or viral infection likely affecting the central nervous system

Use of opioids ≥ 30 mg morphine equivalents on average per month

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

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.

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.

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.

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.

Exclusion Criteria

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

Select...

I have an infection that may be affecting my brain or spinal cord.

Select...

I use opioids equal to or more than 30 mg of morphine a month.

Select...

I am currently taking valproate and clobazam.

Select...

I have not had a major heart problem in the last 10 years.

Select...

I have not had surgery or changed my opioid medication during the study.

Select...

I haven't taken any immunosuppressive drugs in the last 2 weeks.

Select...

I have epilepsy.

Select...

I have been hospitalized for a head injury.

Timeline

Screening ~ 3 weeks3 visits

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

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

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

Primary study objectives

Changes in Neuroinflammation in the Thalamus

Secondary study objectives

Change in Clinical Pain Ratings

Change in Depressive Symptoms

Change in Pain Bothersomeness

+4 more

Other study objectives

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

headache

Blurred Vision

Cold Symptoms

Gastrointestinal Upset

anxiety

100%

80%

60%

40%

20%

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

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

~530

0 / 11Eligibility criteria met