Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03215940
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Deborah Yurgelun-Todd, University of Utah

Tracking Information
First Submitted Date  ICMJE June 27, 2017
First Posted Date  ICMJE July 12, 2017
Last Update Posted Date November 13, 2019
Actual Study Start Date  ICMJE February 1, 2018
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03215940 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 11, 2017)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC)
Official Title  ICMJE Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC): Effectiveness, Side Effects and Neurobiological Changes
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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain, Widespread
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Delta-9-Tetrahydrocannabinol
  • 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.
    Intervention: Drug: Cannabidiol
  • 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.
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2017)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Matt Hodgkinson, B.S.,RN 801-213-0658 chronic_pain_study_utah@umail.utah.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03215940
Other Study ID Numbers  ICMJE IRB_00103451
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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.
Responsible Party Deborah Yurgelun-Todd, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Deborah Yurgelun-Todd, Ph.D. University of Utah Brain Institute
PRS Account University of Utah
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP