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

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ClinicalTrials.gov Identifier: NCT03215940
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Deborah Yurgelun-Todd, 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.

Condition or disease Intervention/treatment Phase
Chronic Pain, Widespread Drug: Delta-9-Tetrahydrocannabinol Drug: Cannabidiol Drug: Placebos Early Phase 1

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  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC): Effectiveness, Side Effects and Neurobiological Changes
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
Drug Information available for: Dronabinol

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 Name: 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 Name: placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215940


Contacts
Contact: Matt Hodgkinson, B.S.,RN 801-213-0658 chronic_pain_study_utah@umail.utah.edu

Locations
United States, Utah
University Of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Deborah Yurgelun-Todd, Ph.D. University of Utah Brain Institute

Responsible Party: Deborah Yurgelun-Todd, Director of the Brain Institute, University of Utah
ClinicalTrials.gov Identifier: NCT03215940     History of Changes
Other Study ID Numbers: IRB_00103451
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists