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Completed

NCT Number: NCT03215940

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

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

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Key information

Conditions

Chronic Pain, Widespread Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University Of Utah

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: THC, Delta-9-THC

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.

Other names: CBD

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.

Other names: placebo

Primary outcomes

  1. Brain Changes

    Time frame: 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 outcomes

  1. Improvement in pain relief

    Time frame: 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.

Other outcomes

  1. Neurocognitive performance

    Time frame: 3 days

    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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2017
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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