Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-21

Study Completion Date

2027-06-30

Brief Summary

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Chronic neuropathic pain (CNP) is disabling. Research on frontline treatments for CNP, shows inconsistent outcomes and dissatisfaction among Veterans. Veterans and clinicians have shown significant interest in cannabis derivatives (THC, CBD) for neuropathic pain control, but there are no well-controlled trials guiding expectations for benefit and adverse outcomes associated with cannabis for CNP. Because Veterans are likely to present with pain and pain-related polymorbidity significantly differing from that of civilians, a well-structured clinical trial of cannabinoids for Veterans with CNP is vital.

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Detailed Description

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Chronic pain is a significant burden to United States Veterans and is a particular concern for Veterans. One of the causes of pain is chronic neuropathic pain (CNP). Frontline treatment for CNP, show inconsistent outcomes and have significant side effects. The ongoing opioid crisis has led to significant interest in safe and effective alternatives for pain control, and there is a significant need for research on desirable options for pain control that are likely to improve treatment adherence and outcomes. Veterans groups and Veterans Affairs clinicians have expressed significant interest in cannabis and its principal constituents (delta-9-tetrahydrocannabinol, THC; cannabidiol, CBD) for pain management, but the extant research describing the potential risks and benefits of cannabis for pain is weak. This randomized trial was developed as a proof of concept study to determine if cannabis constituents (THC, CBD, and THC+CBD) are superior to placebo in reducing pain in Veterans with CNP. The study is to recruit a sample of 320 adult Veterans who meet diagnostic criteria for high-impact CNP, are on stable treatment(s) for CNP, are not current cannabis users and who do not meet diagnostic criteria for Cannabis Use Disorder. This randomized phase II, 4-arm clinical trial aims to determine if cannabis constituents (THC, CBD) or their combination (THC+CBD) are superior to placebo in reducing pain in Veterans with CNP. This trial will offer the first evidence describing the potential benefits and adverse effects of cannabinoids for CNP in Veterans.

Conditions

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Diabetic Neuropathic Pain Peripheral Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind, randomized, placebo-controlled, parallel group Phase II study with randomization to one of the four treatment arms: 1) 10 mg mg THC , 2) 800 mg CBD , 3) 10.8 mg THC + 10 mg CBD , and 4) placebo. The 8-week treatment phase comprises a 2-week up-titration, 4 weeks maintenance on the target dose followed by 2 weeks down-titration, to minimize cannabis withdrawal syndrome. The two-weeks up titration phase is to minimize side effects and improve tolerability. Efficacy will be assessed by responses during the 4-week target dose phase.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Placebo

Intervention Type DRUG

Placebo

Interventions

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THC (Syndros)

Participants will receive a target dose of 10mg per day of THC (Syndros).

Intervention Type DRUG

CBD (Epidolex)

Participants will receive a target dose of 800 mg per day of CBD (Epidolex).

Intervention Type DRUG

THC + CBD (Nabiximols)

Participants will receive a target dose of 10.8 mg / 10 mg per day of THC + CBD (Nabiximols).

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Able to provide written consent
* Veterans 21 years and older at the date of screening
* Meet diagnostic criteria for neuropathic pain as defined by the Neuropathic Pain Special Interest Group of the International Association for the Study of Pain (NeuPSIG)
* Meet criteria for persistent, high-impact pain criteria.
* Presence of allodynia confirmed by one of the screening dynamic brush tests

Exclusion Criteria

* Peripheral neuropathy is not a primary source of neuropathic pain
* Hypersensitivity to THC, CBD, or THC/CBD
* Self-report of cannabis use during screening phase confirmed by positive urine toxicology for THC-COOH as measured and resulted at visit 5 before randomization
* Unwilling to refrain from using cannabis or cannabis-based products through the entire duration of the study
* Diagnosis of DSM-5 Cannabis Use Disorder in the past 6 months
* Current DSM-5 diagnosis of cannabis use disorder, substance use disorder or serious psychiatric disorders
* Actual change or intent to change is greater than a 20% change (increase or decrease) in any other medication for pain or non-pharmacological treatment from 4 weeks before the screening appointment until completion of study (i.e., visit 13)
* Opioid doses \> 400 mg MME (morphine milligram equivalent)
* Women who are pregnant or breastfeeding, or who intend to become pregnant in the 12 weeks from enrollment
* Any current unstable or concerning medical condition that would place the patient at increased risk, including hepatic, respiratory, immunological, cardiovascular, endocrine, or renal disease, or in the opinion of the investigator, prevents adherence with the protocol
* Need for immediate psychiatric hospitalization
* Enrolled in a medical marijuana program
* Federal employee

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No