Clinical trial NCT03984565: PAIN: a Project Assessing the Impact of a Novel Cannabinoid Product
Official title: PAIN: a Project Assessing the Impact of a Novel Cannabinoid Product
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Pain
Keywords: Cannabidiol
Medical Cannabis
Industrial Hemp
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Etheridge Foundation
First posted: 2019-06-13
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain ratings on a Numerical Rating Scale (NRS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in pain ratings on the Brief Pain Inventory (BPI)
timeFrame: 6 weeks
measure: Change in ratings on the Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: 6 weeks
measure: Change in ratings on the Pain Distress Scale (PDS)
timeFrame: 6 weeks
measure: Change in ratings on the Pain Disability Index (PDI)
timeFrame: 6 weeks
measure: Change in Conventional Medication Use
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Staci Gruber, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: