Assessing the impact of a novel cannabinoid product on chronic pain
PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product
PHASE2 · Mclean Hospital · NCT03984565
This study is testing a new CBD product to see if it can help people with chronic pain feel better compared to a placebo.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Mclean Hospital (other) |
| Locations | 1 site (Belmont, Massachusetts) |
| Trial ID | NCT03984565 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a high-cannabidiol (CBD) sublingual product against a placebo over 9 weeks in patients suffering from chronic pain conditions. The study aims to measure the effects of CBD on pain symptoms, medication use, quality of life, cognition, and biomarkers. Participants will undergo assessments at baseline and throughout the treatment period to gather comprehensive data on the efficacy of the cannabinoid product. The trial is designed as a placebo-controlled crossover study, allowing for direct comparison of the treatment effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with musculoskeletal chronic pain conditions such as arthritis or chronic pain due to injury.
Not a fit: Patients with primary neuropathic pain, cancer-related pain, or serious medical illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel therapeutic option for managing chronic pain with fewer side effects compared to traditional medications.
How similar studies have performed: Previous studies have shown promising results for the use of cannabinoids in treating chronic pain, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Belmont, Massachusetts
- McLean Hospital — Belmont, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Staci Gruber, Ph.D. — Mclean Hospital
- Study coordinator: Staci Gruber, Ph.D.
- Email: gruber@mclean.harvard.edu
- Phone: 617-855-2762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Pain, Cannabidiol, Medical Cannabis, Industrial Hemp