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

NCT03215940 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB_00103451
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pain, Widespread

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement in pain relief

  7 days

Other Outcomes (1)

• Neurocognitive performance

  3 days

Study Arms (3)

Delta-9-Tetrahydrocannabinol's (Delta-9-THC) effects on pain

ACTIVE COMPARATOR

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

Cannabidiol's (CBD) effects on pain

ACTIVE COMPARATOR

This arm will be testing the analgesic effects of orally dosed Cannabidiol on subjects with chronic non-cancer pain.

Drug: Cannabidiol

Placebo

PLACEBO COMPARATOR

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

Interventions

Delta-9-Tetrahydrocannabinol DRUG

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.

Also known as: THC, Delta-9-THC

Delta-9-Tetrahydrocannabinol's (Delta-9-THC) effects on pain

Cannabidiol DRUG

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.

Also known as: CBD

Cannabidiol's (CBD) effects on pain

Placebos DRUG

An oral placebo will be given once a day for five day with pain ratings taken before and after each dose every day.

Also known as: placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University Of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Dronabinol; Cannabidiol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Deborah Yurgelun-Todd, Ph.D.

  University of Utah Brain Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Brain Institute

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 12, 2017
• Study Start: February 1, 2018
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

US (1)