PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product

This study is a clinical trial of a high-cannabidiol (CBD) sublingual product for 6 weeks in patients with chronic pain conditions. The study will assess the impact of CBD on chronic pain symptoms, conventional medication use, clinical state, quality of life, and cognition.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: Cannabidiol; Drug: Placebo

Detailed Description

Cannabis sativa has been used medicinally to treat a wide range of disorders for thousands of years. Cannabis is comprised of more than 100 cannabinoids, including D9-tetrahydrocannabinol (THC), the major intoxicating constituent, and cannabidiol (CBD), the major non-intoxicating constituent that has a number of potential therapeutic properties. Although a wide range of medical cannabis (MC) and hemp products (containing less than 0.3% THC) are used by consumers for a variety of medical indications, little is known about the direct impact of individual cannabinoids and constituent ratios on the symptoms that cause patients to seek treatment.

Chronic pain is one of the most common indications for MC use, and several studies have yielded compelling data suggesting that MC and its constituents may have analgesic and anti-inflammatory properties, suggesting that cannabinoids may have the potential to treat chronic pain. This investigation will involve an open-label to double-blind, placebo-controlled trial of a hemp-derived high-CBD, low-THC sublingual product in patients with chronic pain; patients will be assessed at baseline and over 6 weeks of treatment with CBD or placebo on measures of clinical state, including pain and related symptoms, conventional medication use, and cognition.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Staci Gruber, Ph.D.; Phone Number: 617-855-2762; Email: gruber@mclean.harvard.edu
• Study Contact Backup: Name: Rosie Smith, B.S.; Phone Number: 617-855-3338; Email: cbdstudy@mclean.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject has provided informed consent
• Subject is 21 or older
• Subject is fluent in English
• Subject endorses a chronic pain condition including, but not limited to, chronic pain due to injury, musculoskeletal pain, arthritis (including osteoarthritis and rheumatoid arthritis), fibromyalgia, bursitis, endometriosis, etc.

Exclusion Criteria:

• Non-fluent English speakers
• Estimated IQ < 75
• A history of head injury or loss of consciousness greater than 5 minutes
• Currently uses cannabis or CBD products
• Female subjects will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding
• Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease (hyper/hypotension, cardiac disorders), or neurological disorder (including seizure disorder)
• Neuropathic pain or cancer-related pain
• Disclosure of a genetic polymorphism affecting CYP2C9 function

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cannabidiol Treatment Arm; High-CBD sublingual product administered three times daily for 6 weeks	Drug: Cannabidiol; High-CBD, low-THC sublingual product formulated in palm oil; Other Names: CBD
Placebo Comparator: Placebo Treatment Arm; Placebo sublingual product administered three times daily for 6 weeks	Drug: Placebo; Placebo sublingual product formulated in palm oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain ratings on a Numerical Rating Scale (NRS)	The NRS is an 11-point scale on which subjects rate their pain by choosing a number between 0 (no pain) and 10 (worst possible pain). Lower scores indicate less pain.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain ratings on the Brief Pain Inventory (BPI)	The BPI contains 9 questions that assess the severity of pain, how much relief is provided by treatment, and the functional impact of the pain within the last 24 hours. Lower scores are better.	6 weeks
Change in ratings on the Pain Self-Efficacy Questionnaire (PSEQ)	The PSEQ contains several questions assessing the patients' confidence in carrying out certain activities despite their pain on a 7-point scale ranging from 0 (not at all confident) to 6 (completely confident). Higher scores are better.	6 weeks
Change in ratings on the Pain Distress Scale (PDS)	The PDS is an 11-point scale one where subjects rate their pain by level of distress the pain causes on a scale of 0 to 10. Lower scores are better.	6 weeks
Change in ratings on the Pain Disability Index (PDI)	On the PDI, the subject rates how their pain affects 7 different areas of their life on a scale of the level of disability that their pain causes, from "no disability" to "worst disability". Lower scores are better.	6 weeks
Change in Conventional Medication Use	Change in conventional medication use, including opioids, will be assessed and analyzed. Changes in dose and frequency of conventional medication use will be quantified.	6 weeks

Collaborators and Investigators

• Sponsor: Staci Gruber, Ph.D.
• Collaborators: Etheridge Foundation
• Investigators: Principal Investigator: Staci Gruber, Ph.D., McLean Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Cannabidiol; Medical Cannabis; Industrial Hemp
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: 2023P001774

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No