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 : February 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: Cannabidiol Drug: Placebo||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|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)|
|Official Title:||Sublingual Cannabidiol for Chronic Pain|
|Estimated Study Start Date :||July 2021|
|Estimated Primary Completion Date :||July 31, 2023|
|Estimated Study Completion Date :||July 31, 2023|
Experimental: Cannabidiol Treatment Arm
20mg/ml CBD sublingual product administered twice daily for 6 weeks
Cannabidiol sublingual product formulated in coconut oil
Other Name: CBD
Placebo Comparator: Placebo Treatment Arm
Placebo sublingual product administered twice daily for 6 weeks
Placebo sublingual product formulated in coconut oil
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Staci Gruber, Ph.D.||firstname.lastname@example.org|
|Contact: Rosie Smith, B.S.||email@example.com|
|Principal Investigator:||Staci Gruber, Ph.D.||Mclean Hospital|