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

Early Phase 1

Completed

• Conditions: Chronic Pain, Widespread
• Interventions: Drug: Placebos; Drug: Cannabidiol; Drug: Delta-9-Tetrahydrocannabinol

• Registration Number: NCT03215940
• Lead Sponsor: University of Utah

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.

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 Timeline

• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-12
• Study Start: 2018-02-01
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	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.
Cannabidiol's (CBD) effects on pain	Cannabidiol	This arm will be testing the analgesic effects of orally dosed Cannabidiol on subjects with chronic non-cancer pain.
Delta-9-Tetrahydrocannabinol's (Delta-9-THC) effects on pain	Delta-9-Tetrahydrocannabinol	This arm will be testing the analgesic effects of orally dosed Delta-9-Tetrahydrocannabinol on subjects with chronic non-cancer pain.

Primary Outcome Measures

Name	Time	Method
Brain Changes	5 days	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.

Secondary Outcome Measures

Name	Time	Method
Improvement in pain relief	7 days	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.

Trial Locations

Locations (1)

University Of Utah; 🇺🇸 Salt Lake City, Utah, United States