CBD for Chronic Radicular Pain on Chronic Opioid Therapy (COT)
|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: NCT04760613|
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : August 29, 2022
|Condition or disease||Intervention/treatment||Phase|
|Radiculopathy||Drug: Cannabidiol Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||The trial will employ a double-blind pharmacologic intervention methodology where the investigational drug (CBD) and matched placebo oral pills will be masked in identically appearing capsules provided by the drug sponsor.|
|Official Title:||A Phase I/II, Randomized, Double-blind, Placebo-controlled, Single-center Study of the Effects of Cannabidiol (CBD) on Opioid Plasma Levels in Participants With Chronic Radiculopathic Pain Syndromes Maintained on Chronic Opioid Therapy (COT)|
|Actual Study Start Date :||February 3, 2022|
|Estimated Primary Completion Date :||June 1, 2023|
|Estimated Study Completion Date :||August 1, 2023|
|Active Comparator: Cannabidiol (CBD)||
600 mg oral daily use (each capsule of active drug contains 50 mg of CBD)
|Placebo Comparator: Placebo (PCB)||
identical capsules containing placebo (taken daily by mouth)
- Change in Opioid Analgesic Plasma Levels [ Time Frame: Week 0, Week 2 ]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).
- Change in CBD Plasma Levels [ Time Frame: Week 0, Week 2 ]CBD plasma levels will be determined via High Performance Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS).
- Change in Score on Pain Catastrophizing Scale (PCS) [ Time Frame: Week 0, Week 2 ]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.
- Change in Brief Pain Inventory (BPI) Score [ Time Frame: Week 0, Week 2 ]
BPI - Short Form is a self-administered questionnaire. It evaluates:
- Pain intensity: 4 questions answered on a Likert scale of 0 (no pain) to 10 (pain as bad as you can imagine). Total range of score is 0-40, where a higher score indicates more intense pain.
- Pain-related interference: 7 categories answered on a Likert scale of 0 (does not interfere) to 10 (completely interferes). Total range of score is 0-70, where a higher score indicates more pain-related interference.
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): NCT04760613
|Contact: Stephen Ross, MD||212-263-6289||Stephen.email@example.com|
|Contact: Angela West, MAfirstname.lastname@example.org|
|United States, New York|
|NYU Langone Health||Recruiting|
|New York, New York, United States, 10016|
|Contact: Angela West, MA 212-263-6283 email@example.com|
|Principal Investigator: Stephen Ross, MD|
|Principal Investigator:||Stephen Ross, MD||NYU Langone Health|