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

Sponsor
University of Utah (Other)
Overall Status
Recruiting
CT.gov ID
NCT03215940
Collaborator
(none)
75
Enrollment
1
Location
3
Arms
60.9
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2018
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Other Outcome Measures

    1. Neurocognitive performance [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Of Utah 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Deborah Yurgelun-Todd, Director of the Brain Institute, University of Utah
    ClinicalTrials.gov Identifier:
    NCT03215940
    Other Study ID Numbers:
    • IRB_00103451
    First Posted:
    Jul 12, 2017
    Last Update Posted:
    Mar 10, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Dronabinol
    Cannabidiol

    Study Results

    No Results Posted as of Mar 10, 2022