PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cannabidiol, Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Pain. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Cannabidiol
High-CBD, low-THC sublingual product formulated in palm oil - Drug Placebo
Placebo sublingual product formulated in palm oil with supplemental terpenes to match CBD product.
Primary outcome measures
- Change in pain ratings on a Numerical Rating Scale (NRS) [Time frame: 6 weeks]
Secondary outcome measures (5)
- Change in pain ratings on the Brief Pain Inventory (BPI) [Time frame: 6 weeks]
- Change in ratings on the Pain Self-Efficacy Questionnaire (PSEQ) [Time frame: 6 weeks]
- Change in ratings on the Pain Distress Scale (PDS) [Time frame: 6 weeks]
- Change in ratings on the Pain Disability Index (PDI) [Time frame: 6 weeks]
- Change in Conventional Medication Use [Time frame: 6 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- McLean Hospital — Belmont
Identifiers
NCT: NCT03984565 · 2023P001774