Effects of CBD/CBD-A Oral Extract on Resting-state EEG and Neuropathic Pain Symptoms After SCI

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT05630235
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

  • Neuropathic Pain
  • SCI - Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • CBD/CBD-A — DRUG
    Participants will be administered a one-time dose of 204.6 mg of CBD/CBD-A orally.
  • Placebo — OTHER
    The placebo equivalent of the CBD/CBD-A dose administered orally.

Study Details

The main purposes of this study are to (1) measure the effect of CBD/CBD-A on pain symptoms, pain intensity, pain unpleasantness, and skin sensitivity to hot and cold temperatures; and (2) measure the effect of CBD on brain electrical activity with electroencephalography (EEG).

Key Dates

Start date
Jun 16, 2025
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: CBD/CBD-A followed by placebo group
    Participants in this group will receive a one time dose of CBD/CBD-A on visit 2, followed by a placebo on visit 3 after a two-week period.
  • Experimental: Placebo followed by CBD/CBD-A group
    Participants in this group will receive a placebo on visit 2, followed by a one time of CBD/CBD-A on visit 3 after a two-week period.

Primary Outcome Measure

Change in neuropathic pain intensity or unpleasantness. [ Time Frame: Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lynn Rehabilitation CenterMiamiFlorida33136
Eva Widerstrom-Noga, PhD, DDS
305-243-7125
Eva Widerstrom-Noga, PhD, DDS (PRINCIPAL_INVESTIGATOR)

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