Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC)

Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC): Effectiveness, Side Effects and Neurobiological Changes

This is a study comparing the effects of Delta-9-Tetrahydrocannabinol (THC) versus Cannabidiol (CBD) versus a placebo on chronic non-cancer pain.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain, Widespread
• Intervention / Treatment: Drug: Delta-9-Tetrahydrocannabinol; Drug: Cannabidiol; Drug: Placebos

Detailed Description

The overall aim of this study is to examine the effects of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) on chronic pain symptoms, specifically we will examine the effects of different doses of THC/CBD on symptoms of chronic pain and life functioning. Participants will include individuals with chronic pain, who will be randomized into one of three intervention conditions: high THC/low CBD, low THC/high CBD, or placebo. In addition to receiving THC/CBD/placebo, participants also will complete symptom assessments of chronic pain data (intensity, quality, interference/disability) throughout the study. These measures will be gathered prior to and following the fifth doses (dosing will occur once per day for five days) of CBD/THC or placebo. A secondary objective will be to examine the association between clinical and neurocognitive variables and use of CBD/THC, including the potential side effects of THC/CBD. Other secondary objectives include the use of magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS), acquired before and after final administration with CBD/THC or placebo to examine differences in brain metabolism, brain connectivity, and brain structure. Imaging analyses will focus on regional brain changes before and after administration of THC/CBD/placebo.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Matt Hodgkinson, B.S.,RN; Phone Number: 801-213-0658; Email: chronic_pain_study_utah@umail.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • Recruiting
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Age between 18-50 yrs.
2. History of cannabis use.
3. Chronic musculoskeletal and joint pain for at least 3 months or longer.
4. Participants must live within a 60 mile radius of Salt Lake City, Utah to be eligible.

Exclusion criteria:

1. Current or past neurological illness.
2. Substance abuse or dependence within the prior 60 days.
3. Contraindication to brain MRI.
4. Type I and type II diabetes.
5. Unstable medical conditions.
6. Consumption of more than 2 drinks of alcohol per night.
7. Current pregnancy or planning to become pregnant or breastfeeding
8. History of seizures or head trauma
9. Active or history of major mental illness
10. LFT results 3 times greater than the upper limit of normal at screening.
11. Participants may be excluded if the PI feels they do not meet safety criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Delta-9-Tetrahydrocannabinol's (Delta-9-THC) effects on pain; This arm will be testing the analgesic effects of orally dosed Delta-9-Tetrahydrocannabinol on subjects with chronic non-cancer pain.	Drug: Delta-9-Tetrahydrocannabinol; An oral dose of Delta-9-Tetrahydrocannabinol (THC) will be given once a day for five day with pain ratings taken before and after each dose every day.; Other Names: THC; Delta-9-THC
ACTIVE_COMPARATOR: Cannabidiol's (CBD) effects on pain; This arm will be testing the analgesic effects of orally dosed Cannabidiol on subjects with chronic non-cancer pain.	Drug: Cannabidiol; An oral dose of Cannabidiol (CBD) will be given once a day for five day with pain ratings taken before and after each dose every day.; Other Names: CBD
PLACEBO_COMPARATOR: Placebo; This Placebo arm will act as the control as standard of care medications will be continued through the study. This arm will allow us to compare the analgesic effects of the other two arms with the standard of care treatments for chronic non-cancer pain.	Drug: Placebos; An oral placebo will be given once a day for five day with pain ratings taken before and after each dose every day.; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain Changes	Participants will undergo MRI scanning designed to assess white matter microstructure and focal brain activation at the baseline visit (day 1) and visit five (day 5) in order to determine whether the administration of Delta-9-THC, CBD, or Placebo will result in changes to these brain indices in participants with chronic pain.	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in pain relief	Using baseline assessment measures gathered at visit 0 (Screening), assessments collected at visits 1-5 and follow-up will be used to determine wether the administration of Delta-9-THC, CBD, or placebo will improve pain relief in individuals with chronic pain.	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurocognitive performance	Using baseline assessment measures gathered at visit 1, assessments collected at visits 5 and follow-up will be used to determine wether the administration of Delta-9-THC, CBD, or placebo will adversely effect neurocognitive performance in individuals with chronic pain.	3 days

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Deborah Yurgelun-Todd, Ph.D., University of Utah Brain Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2018
• Primary Completion (ANTICIPATED): December 30, 2022
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: July 11, 2017
• First Posted (ACTUAL): July 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Anticonvulsants; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol; Cannabidiol
• Other Study ID Numbers: IRB_00103451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators are still deciding on if and what IPD will be shared and the details involved. The investigators will update when a plan is in place.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No