PAIN: a Project Assessing the Impact of a Novel Cannabinoid Product
NCT ID: NCT03984565
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
25 participants
INTERVENTIONAL
2024-06-27
2026-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Cannabidiol Treatment Arm
High-CBD sublingual product administered three times daily for the treatment period.
Cannabidiol
High-CBD, low-THC sublingual product formulated in palm oil
Placebo Treatment Arm
Placebo sublingual product administered three times daily for the treatment period.
Placebo
Placebo sublingual product formulated in palm oil with supplemental terpenes to match CBD product.
Interventions
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Cannabidiol
High-CBD, low-THC sublingual product formulated in palm oil
Placebo
Placebo sublingual product formulated in palm oil with supplemental terpenes to match CBD product.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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Etheridge Foundation
UNKNOWN
Staci Gruber, Ph.D.
OTHER
Responsible Party
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Staci Gruber, Ph.D.
Director, Marijuana Investigations for Neuroscientific Discovery; Director, Cognitive and Clinical Neuroimaging Core; Associate Professor of Psychiatry, Harvard Medical School
Principal Investigators
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Staci Gruber, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mclean Hospital
Locations
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McLean Hospital
Belmont, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023P001774
Identifier Type: -
Identifier Source: org_study_id
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