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

NCT04586712 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB201903330
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Self-report Ratings of Muscle Soreness

  A muscle soreness inventory will be used to self-report the level of soreness. The muscle soreness inventory consists of rating soreness on a visual analog scale (VAS). A 10cm line is drawn with 0 (no soreness) on the left pole and 10 (extreme soreness) on the right pole.

  Baseline (Day 1)

• Self-report Ratings of Muscle Soreness

  A muscle soreness inventory will be used to self-report the level of soreness. The muscle soreness inventory consists of rating soreness on a visual analog scale (VAS). A 10cm line is drawn with 0 (no soreness) on the left pole and 10 (extreme soreness) on the right pole.

  Pre-exercise (Day 10)

• Self-report Ratings of Muscle Soreness

  A muscle soreness inventory will be used to self-report the level of soreness. The muscle soreness inventory consists of rating soreness on a visual analog scale (VAS). A 100mm line is drawn with 0 (no soreness) on the left pole and 100 (extreme soreness) on the right pole.

  Post-exercise (Day 12)

• Self-report Ratings of Disability

  Disability will be measured using the Lower Extremity Functional Scale (LEFS). LEFS score = SUM (points for all 20 activities) Interpretation: Minimum score: 0 Maximum score: 80 The lower the score the greater the disability.

  Baseline (Day 1)

• Self-report Ratings of Disability

  Disability will be measured using the Lower Extremity Functional Scale (LEFS). LEFS score = SUM (points for all 20 activities) Interpretation: Minimum score: 0 Maximum score: 80 The lower the score the greater the disability.

  Pre-exercise (Day 10)

• Self-report Ratings of Disability

  Disability will be measured using the Lower Extremity Functional Scale (LEFS). LEFS score = SUM (points for all 20 activities) Interpretation: Minimum score: 0 Maximum score: 80 The lower the score the greater the disability.

  Post-exercise (Day 12)

Secondary Outcomes (10)

• Pain Anxiety Symptom Scale - 20 (PASS-20)

  Pre-exercise (Day 10)

• Pain Anxiety Symptom Scale (PASS-20)

  Post-exercise (Day 15)

• Pain Catastrophizing Scale (PCS)

  Baseline (Day 1)

• Pain Catastrophizing Scale (PCS)

  Pre-exercise (Day 10)

• Pain Catastrophizing Scale (PCS)

  Post-exercise (Day 15)

Study Arms (2)

Active CBD-extract

EXPERIMENTAL

Active Dose (2000mg/30mL hemp extract = 67.5mg/day)

Drug: Active CBD

Vehicle-Control (Placebo)

PLACEBO COMPARATOR

(0mg/30mL hemp extract = no hemp extract)

Drug: Vehicle Control (Placebo)

Interventions

Active CBD DRUG

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

Also known as: 2000mg/30mL

Active CBD-extract

Vehicle Control (Placebo) DRUG

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

Vehicle-Control (Placebo)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• University of Florida: lead
• Consortium for Medical Marijuana Clinical Outcomes Research: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Results Point of Contact

• Title: Dr. Paul Borsa
• Organization: University of Florida

pborsa@ufl.edu

352-294-1726

Study Officials

• Paul Borsa, PhD, ATC

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: March 1, 2021
• Primary Completion: March 21, 2024
• Study Completion: March 21, 2024
• Last Updated: August 6, 2025
• Results First Posted: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)