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Sublingual Cannabidiol for Chronic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03984565
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : March 15, 2023
Sponsor:
Information provided by (Responsible Party):
Staci Gruber, Ph.D., Mclean Hospital

Study Description
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Brief Summary:
This study involves taking a high-cannabidiol (CBD) sublingual product for 6 weeks in order to assess the impact of CBD on chronic pain, conventional medication use, clinical state, quality of life, cognition, and where applicable, brain structure and function via neuroimaging.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Cannabidiol Drug: Placebo Phase 2

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 psychoactive constituent, and cannabidiol (CBD), the major non-intoxicating constituent that has demonstrated significant medicinal properties for a variety of disorders. Currently, 33 states and the District of Columbia have enacted full medical marijuana (MMJ) programs, and 14 states allow limited access to CBD-containing products. MMJ products can vary drastically in their cannabinoid constituent quantities and ratios, ranging from high THC products with very little CBD, to 1:1 ratios of THC to CBD, to high CBD products with very little THC. Although a wide range of products exist and are being actively used by consumers with a variety of medical indications, little is known about the direct impact of certain cannabinoids and constituent ratios on the symptoms that cause patients to seek treatment.

Chronic pain is one of the most common indications for MMJ use, and several studies have yielded compelling data suggesting that MMJ and its constituents may have analgesic and anti-inflammatory properties, suggesting that particular cannabinoids may have the potential to treat chronic pain. To date, no clinical trials have been conducted assessing the effects of a high-CBD, low-THC product for chronic pain. This investigation will involve a an open-label to double-blind, placebo-controlled trial of a high-CBD sublingual product; patients will be assessed at baseline and over 6 weeks of treatment with CBD or placebo on measures of clinical state, including pain and related symptoms, conventional medication use, cognition, and brain imaging (as appropriate).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study consists of two phases: an open-label phase followed by a double-blind, placebo-controlled, randomized trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sublingual Cannabidiol for Chronic Pain
Estimated Study Start Date : June 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
Drug Information available for: Cannabidiol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cannabidiol Treatment Arm
20mg/ml CBD sublingual product administered twice daily for 6 weeks
 Drug: Cannabidiol
Cannabidiol sublingual product formulated in coconut oil
Other Name: CBD
Placebo Comparator: Placebo Treatment Arm
Placebo sublingual product administered twice daily for 6 weeks
 Drug: Placebo
Placebo sublingual product formulated in coconut oil


Outcome Measures
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Primary Outcome Measures :
  1. Change in pain ratings on the Brief Pain Inventory (BPI) [ Time Frame: 6 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in ratings on the Pain Self-Efficacy Questionnaire (PSEQ) [ Time Frame: 6 weeks ]
    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.

  2. Change in pain ratings on the Numerical Rating Scale (NRS) [ Time Frame: 6 weeks ]
    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 are better.

  3. Change in ratings on the Pain Distress Scale (PDS) [ Time Frame: 6 weeks ]
    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.

  4. Change in ratings on the Pain Disability Index (PDI) [ Time Frame: 6 weeks ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has provided informed consent
  • Subject is 21 or older
  • Subject is a native English speaker or acquired English prior to age 5
  • Subject endorses a chronic pain condition including, but not limited to, chronic pain due to injury, musculoskeletal pain, arthritis (including osteoarthritis and rheumatoid arthritis), fibromyalgia, bursitis, endometriosis, etc.

Exclusion Criteria:

  • Non-native English speakers
  • Estimated IQ < 75
  • A history of head injury or loss of consciousness greater than 5 minutes
  • Currently uses marijuana or CBD products
  • 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 medical illness, including liver, kidney, or cardiovascular disease (hyper/hypotension, cardiac disorders), or neurological disorder (including seizure disorder)
  • Neuropathic pain or cancer-related pain
  • Disclosure of a genetic polymorphism affecting CYP2C9 function
  • Coconut allergy, as the product is formulated in coconut oil
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984565


Contacts
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Contact: Staci Gruber, Ph.D. 617-855-2762 gruber@mclean.harvard.edu
Contact: Rosie Smith, B.S. 617-855-3653 brainstudy@mclean.harvard.edu

Sponsors and Collaborators
Staci Gruber, Ph.D.
Investigators
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Principal Investigator: Staci Gruber, Ph.D. Mclean Hospital
More Information
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Responsible Party: Staci Gruber, Ph.D., Director, Marijuana Investigations for Neuroscientific Discovery; Director, Cognitive and Clinical Neuroimaging Core; Associate Professor of Psychiatry, Harvard Medical School, Mclean Hospital
ClinicalTrials.gov Identifier: NCT03984565    
Other Study ID Numbers: 2019P001480
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: March 15, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Staci Gruber, Ph.D., Mclean Hospital:
Cannabidiol
Medical Marijuana
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Cannabidiol
Anticonvulsants