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Sublingual Cannabidiol for Chronic Pain

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ClinicalTrials.gov Identifier: NCT03984565
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Staci Gruber, Ph.D., Mclean Hospital

Tracking Information
First Submitted Date  ICMJE June 7, 2019
First Posted Date  ICMJE June 13, 2019
Last Update Posted Date June 13, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • 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).
  • 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).
  • 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.
  • 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".
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sublingual Cannabidiol for Chronic Pain
Official Title  ICMJE Sublingual Cannabidiol for Chronic Pain
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Drug: Cannabidiol
    Cannabidiol sublingual product formulated in coconut oil
    Other Name: CBD
  • Drug: Placebo
    Placebo sublingual product formulated in coconut oil
Study Arms  ICMJE
  • Experimental: Cannabidiol Treatment Arm
    20mg/ml CBD sublingual product administered twice daily for 6 weeks
    Intervention: Drug: Cannabidiol
  • Placebo Comparator: Placebo Treatment Arm
    Placebo sublingual product administered twice daily for 6 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 10, 2019)
55
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Staci Gruber, Ph.D. 617-855-2762 gruber@mclean.harvard.edu
Contact: Rosie Smith, B.S. 617-855-3653 brainstudy@mclean.harvard.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03984565
Other Study ID Numbers  ICMJE 2019P001480
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Staci Gruber, Ph.D., Mclean Hospital
Study Sponsor  ICMJE Staci Gruber, Ph.D.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Staci Gruber, Ph.D. Mclean Hospital
PRS Account Mclean Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP