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| Name | Class |
|---|---|
| Etheridge Foundation | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol Treatment Arm | Experimental | High-CBD sublingual product administered three times daily for the treatment period. |
|
| Placebo Treatment Arm | Placebo Comparator | Placebo sublingual product administered three times daily for the treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug | High-CBD, low-THC sublingual product formulated in palm oil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain ratings on a Numerical Rating Scale (NRS) | The NRS is an 11-point scale on which subjects rate their pain by choosing a number between 0 (no pain) and 10 (worst possible pain). Lower scores indicate less pain. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain ratings on the Brief Pain Inventory (BPI) | The BPI contains 9 questions that assess the severity of pain, how much relief is provided by treatment, and the functional impact of the pain within the last 24 hours. Lower scores are better. | 6 weeks |
| Change in ratings on the Pain Self-Efficacy Questionnaire (PSEQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Staci Gruber, Ph.D. | Contact | 617-855-2762 | gruber@mclean.harvard.edu | |
| Rosie Smith, M.S. | Contact | 617-855-3338 | cbdstudy@mclean.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Staci Gruber, Ph.D. | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Recruiting | Belmont | Massachusetts | 02478 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo sublingual product formulated in palm oil with supplemental terpenes to match CBD product. |
|
The PSEQ contains several questions assessing the patients' confidence in carrying out certain activities despite their pain on a 7-point scale ranging from 0 (not at all confident) to 6 (completely confident). Higher scores are better. |
| 6 weeks |
| Change in ratings on the Pain Distress Scale (PDS) | The PDS is an 11-point scale one where subjects rate their pain by level of distress the pain causes on a scale of 0 to 10. Lower scores are better. | 6 weeks |
| Change in ratings on the Pain Disability Index (PDI) | On the PDI, the subject rates how their pain affects 7 different areas of their life on a scale of the level of disability that their pain causes, from "no disability" to "worst disability". Lower scores are better. | 6 weeks |
| Change in Conventional Medication Use | Change in conventional medication use, including opioids, will be assessed and analyzed. Changes in dose and frequency of conventional medication use will be quantified. | 6 weeks |