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

Staci Gruber, Ph.D.

Status and phase: Enrolling; Phase 2

Conditions: Chronic Pain

Treatments: Drug: Placebo; Drug: Cannabidiol

Study type: Interventional

Funder types: Other

Identifiers

NCT03984565

2023P001774

Details and patient eligibility

About

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.

Full 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 a placebo-controlled crossover trial of a hemp-derived high-CBD, low-THC sublingual product in patients with chronic pain; patients will be assessed at baseline and over 69weeks of treatment with CBD or placebo on measures of clinical state, including pain and related symptoms, conventional medication use, and cognition, and provide samples for analysis of inflammatory markers.

Enrollment: 25 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

Cannabidiol Treatment Arm

Experimental group

Description:

High-CBD sublingual product administered three times daily for the treatment period.

Treatment:

Drug: Cannabidiol

Placebo Treatment Arm

Placebo Comparator group

Description:

Placebo sublingual product administered three times daily for the treatment period.

Treatment:

Drug: Placebo