RecruitingPhase 2NCT03984565

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

Sponsor

Staci Gruber, Ph.D.

Enrollment

25 participants

Start Date

Jun 27, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Pain

Summary

This study is a clinical trial of a high-cannabidiol (CBD) sublingual product compared to placebo for 9 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, cognition, and biomarkers.

Eligibility

Min Age: 21 Years

Inclusion Criteria4

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

Exclusion Criteria8

Non-fluent English speakers
Estimated IQ < 75
A history of head injury or loss of consciousness greater than 5 minutes
Currently uses CBD products regularly
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)
Primary neuropathic pain or cancer-related pain; patients experiencing neuropathic pain secondary to musculoskeletal pain will be allowed to enter the study
Disclosure of a genetic polymorphism affecting CYP2C9 function

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Interventions

DRUGCannabidiol

High-CBD, low-THC sublingual product formulated in palm oil

DRUGPlacebo

Placebo sublingual product formulated in palm oil with supplemental terpenes to match CBD product.

Locations(1)

McLean Hospital

Belmont, Massachusetts, United States

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NCT03984565

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