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Efficacy of a Controlled Short-term Trial of Cannabidiol (CBD) Ingestion on Reducing Symptomatic Response and Facilitating Recovery After Induced Muscle Injury

NCT04586712 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-08-06

Study results available
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Summary

We aim to determine the efficacy of a controlled short-term trial of CBD ingestion for reducing symptomatic response and facilitating recovery following induced muscle injury. We will assess, in serial fashion, symptomatic response, functional limitations and recovery of the quadriceps muscle following induced injury in which CBD oil (or placebo) will be delivered using a sublingual route of administration during a 15-day pre-injury consumption and post-injury recovery phase. A double-blind, randomized, two-arm study design will be used and participants will be randomly assigned to either an active dose (n=15) or vehicle control group (n=15). The clinical outcomes include measures of muscular pain and disability along with measures of pain-related fear and anxiety.

Conditions

  • Muscle Injury
  • Recovery
  • Pain Relief

Interventions

DRUG

Active CBD

Participants will be provided a viscous liquid in a bottle with a syringe dropper containing CBD-extract oil at concentrations of 2000mg/30mL (high).

DRUG

Vehicle Control (Placebo)

Participants will be provided a viscous liquid in a bottle with a syringe dropper containing placebo containing no CBD oil (0mg/30 mL).

Sponsors & Collaborators

  • Consortium for Medical Marijuana Clinical Outcomes Research

    collaborator OTHER

  • University of Florida

    lead OTHER

Principal Investigators

  • Paul Borsa, PhD, ATC · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2024-03-21
Completion
2024-03-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04586712 on ClinicalTrials.gov