Trial Outcomes & Findings for CBD for Chronic Radicular Pain on Chronic Opioid Therapy (COT) (NCT NCT04760613)

Last Updated: 2024-09-19

Results Overview

Opioid (i.e. the particular opioid used by a participant) analgesic plasma levels will be determined via High Performance Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Baseline, Week 2 Post-Initiation of Treatment

Results posted on

2024-09-19

Participant Flow

There were n=8 participants who were enrolled but failed screening/did not start the trial. Thus, the total number of participants who started the trial is n=6.

Participant milestones

Participant milestones
Measure	Cannabidiol (CBD) Cannabidiol: 600 mg oral daily use (each capsule of active drug contains 50 mg of CBD)	Placebo (PCB) Placebo: identical capsules containing placebo (taken daily by mouth)
Overall Study STARTED	5	1
Overall Study COMPLETED	5	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CBD for Chronic Radicular Pain on Chronic Opioid Therapy (COT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cannabidiol (CBD) n=5 Participants Cannabidiol: 600 mg oral daily use (each capsule of active drug contains 50 mg of CBD)	Placebo (PCB) n=1 Participants Placebo: identical capsules containing placebo (taken daily by mouth)	Total n=6 Participants Total of all reporting groups
Age, Continuous	65.8 years STANDARD_DEVIATION 10.533 • n=5 Participants	54 years STANDARD_DEVIATION NA • n=7 Participants	59.9 years STANDARD_DEVIATION 10.533 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	1 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 2 Post-Initiation of Treatment

Opioid (i.e. the particular opioid used by a participant) analgesic plasma levels will be determined via High Performance Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS).

Outcome measures

Outcome measures
Measure	Cannabidiol (CBD) n=5 Participants Cannabidiol: 600 mg oral daily use (each capsule of active drug contains 50 mg of CBD)	Placebo (PCB) n=1 Participants Placebo: identical capsules containing placebo (taken daily by mouth)
Change in Opioid Analgesic Plasma Levels	10.86 ng/mL Standard Deviation 14.35	-11.4 ng/mL Standard Deviation NA 1 Participant - standard deviation cannot be calculated.

PRIMARY outcome

Timeframe: Day 1 Post-Initiation of Treatment, Week 2 Post-Initiation of Treatment

CBD plasma levels will be determined via High Performance Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS).

Outcome measures

Outcome measures
Measure	Cannabidiol (CBD) n=5 Participants Cannabidiol: 600 mg oral daily use (each capsule of active drug contains 50 mg of CBD)	Placebo (PCB) n=1 Participants Placebo: identical capsules containing placebo (taken daily by mouth)
Change in CBD Plasma Levels	38.28 ng/mL Standard Deviation 31.44	0 ng/mL Standard Deviation NA 1 Participant - standard deviation cannot be calculated.

SECONDARY outcome

Timeframe: Baseline, Week 2 Post-Initiation of Treatment

Population: The participant in the Placebo (PCB) arm did not complete the PCS questionnaire at the Week 2 timepoint so change data was not collected

PCS consists of 13 statements describing different thoughts and feelings that may be associated with pain. The degree to which one has these thoughts and feelings when experiencing pain is indicated on a scale of 0 (not at all) to 4 (all the time). The total range of score is 0-52, with a higher score indicating more frequent negative thoughts.

Outcome measures

Outcome measures
Measure	Cannabidiol (CBD) n=5 Participants Cannabidiol: 600 mg oral daily use (each capsule of active drug contains 50 mg of CBD)	Placebo (PCB) Placebo: identical capsules containing placebo (taken daily by mouth)
Change in Score on Pain Catastrophizing Scale (PCS)	0.6 score on a scale Standard Deviation 8.65	—

SECONDARY outcome

Timeframe: Baseline, Week 2 Post-Initiation of Treatment

Population: The participant in the Placebo (PCB) arm did not complete the PCS questionnaire at the Week 2 timepoint so change data was not collected.

BPI - Short Form is a self-administered questionnaire. It evaluates: 1. Pain intensity: 4 questions answered on a Likert scale of 0 (no pain) to 10 (pain as bad as you can imagine). 2. Pain-related interference: 7 categories answered on a Likert scale of 0 (does not interfere) to 10 (completely interferes). The composite mean of these scores is used as the total pain interference score: the total score ranges from 0-55; higher scores indicate greater pain interference.

Outcome measures

Outcome measures
Measure	Cannabidiol (CBD) n=5 Participants Cannabidiol: 600 mg oral daily use (each capsule of active drug contains 50 mg of CBD)	Placebo (PCB) Placebo: identical capsules containing placebo (taken daily by mouth)
Change in Brief Pain Inventory (BPI) Score	-1.52 score on a scale Standard Deviation 1.49	—

Adverse Events

Cannabidiol (CBD)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo (PCB)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cannabidiol (CBD) n=5 participants at risk Cannabidiol: 600 mg oral daily use (each capsule of active drug contains 50 mg of CBD)	Placebo (PCB) n=1 participants at risk Placebo: identical capsules containing placebo (taken daily by mouth)
Renal and urinary disorders Left nephrolithiasis/pyelonephritis (requiring hospitalization)	0.00% 0/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	100.0% 1/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.

Other adverse events

Additional Information

Stephen Ross, MD

NYU Langone health

Phone: 212-263-6289

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cannabidiol (CBD) n=5 participants at risk Cannabidiol: 600 mg oral daily use (each capsule of active drug contains 50 mg of CBD)	Placebo (PCB) n=1 participants at risk Placebo: identical capsules containing placebo (taken daily by mouth)
Renal and urinary disorders Urinary Tract Infection	0.00% 0/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	100.0% 1/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Gastrointestinal disorders Vomiting	0.00% 0/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	100.0% 1/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Respiratory, thoracic and mediastinal disorders Sore Throat	0.00% 0/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	100.0% 1/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Renal and urinary disorders Left flank pain due to kidney stone	0.00% 0/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	100.0% 1/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Gastrointestinal disorders Diarrhea	40.0% 2/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	100.0% 1/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Cardiac disorders Abnormal EKG	0.00% 0/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	100.0% 1/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Nervous system disorders Headache	40.0% 2/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	100.0% 1/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Injury, poisoning and procedural complications Bruise at IV site	60.0% 3/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	100.0% 1/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Blood and lymphatic system disorders Anemia	0.00% 0/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	100.0% 1/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Blood and lymphatic system disorders Hypoalbuminemia	0.00% 0/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	100.0% 1/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	100.0% 1/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Psychiatric disorders Opiate Withdrawal	0.00% 0/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	100.0% 1/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Cardiac disorders Heart Palpitations	0.00% 0/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	100.0% 1/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Nervous system disorders Somnolence	40.0% 2/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	0.00% 0/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Gastrointestinal disorders Nausea	40.0% 2/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	0.00% 0/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Nervous system disorders Interrupted Sleep	20.0% 1/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	0.00% 0/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Skin and subcutaneous tissue disorders Pruritis	20.0% 1/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	0.00% 0/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Injury, poisoning and procedural complications Bruise at IV Site	60.0% 3/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	0.00% 0/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Cardiac disorders Tachycardia	20.0% 1/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	0.00% 0/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Nervous system disorders Imbalance	20.0% 1/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	0.00% 0/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Nervous system disorders Lightheadedness	40.0% 2/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	0.00% 0/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Cardiac disorders Hypotension	20.0% 1/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	0.00% 0/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Cardiac disorders Bradycardia	20.0% 1/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	0.00% 0/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Gastrointestinal disorders Loose Stool	20.0% 1/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	0.00% 0/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Injury, poisoning and procedural complications Pain at IV site	20.0% 1/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	0.00% 0/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Renal and urinary disorders Increased urination frequency	20.0% 1/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	0.00% 0/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Metabolism and nutrition disorders Decreased appetite	20.0% 1/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	0.00% 0/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Cardiac disorders Hypertension	40.0% 2/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	0.00% 0/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.
Gastrointestinal disorders Abdominal Discomfort	20.0% 1/5 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.	0.00% 0/1 • 2 weeks Safety and toxicity monitoring will be performed throughout the study for all participants. Safety variables to be assessed include AEs, vital signs, and safety laboratory values, when collected.