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Sublingual Cannabidiol for Chronic Pain

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Sponsorid
Staci Gruber, Ph.D.

Märksõnad

Abstraktne

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.

Kirjeldus

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).

Kuupäevad

Viimati kinnitatud: 01/31/2020
Esmalt esitatud: 06/06/2019
Hinnanguline registreerumine on esitatud: 06/09/2019
Esmalt postitatud: 06/12/2019
Viimane värskendus on esitatud: 02/24/2020
Viimati värskendus postitatud: 02/26/2020
Õppe tegelik alguskuupäev: 07/31/2020
Eeldatav esmane lõpetamise kuupäev: 08/30/2022
Eeldatav uuringu lõpetamise kuupäev: 08/30/2022

Seisund või haigus

Chronic Pain

Sekkumine / ravi

Drug: Cannabidiol Treatment Arm

Drug: Placebo Treatment Arm

Faas

Faas 2

Käerühmad

ArmSekkumine / ravi
Experimental: Cannabidiol Treatment Arm
20mg/ml CBD sublingual product administered twice daily for 6 weeks
Drug: Cannabidiol Treatment Arm
Cannabidiol sublingual product formulated in coconut oil
Placebo Comparator: Placebo Treatment Arm
Placebo sublingual product administered twice daily for 6 weeks
Drug: Placebo Treatment Arm
Placebo sublingual product formulated in coconut oil

Abikõlblikkuse kriteeriumid

Õppimiseks sobivad vanused 21 Years To 21 Years
Uuringuks kõlblikud soodAll
Võtab vastu tervislikke vabatahtlikkeJah
Kriteeriumid

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

Tulemus

Esmased tulemusnäitajad

1. Change in pain ratings on the Brief Pain Inventory (BPI) [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.

Sekundaarsed tulemusmõõdud

1. Change in ratings on the Pain Self-Efficacy Questionnaire (PSEQ) [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) [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) [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) [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.

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