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

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.

Study Overview

• Status: Completed
• Conditions: Recovery; Pain Relief; Muscle Injury
• Intervention / Treatment: Drug: Active CBD; Drug: Vehicle Control (Placebo)

Detailed Description

Current research has shown evidence that phytocannabinoids may have a promising therapeutic potential in a variety of physical and psychological ailments, and cannabidiol (CBD) is of particular interest due to its positive safety profile, non-intoxicating effects and widespread capabilities in a number of musculoskeletal diseases. Three primary reasons people consume CBD on a global basis, in addition to the fact that it is non-intoxicating, are for symptomatic (pain) relief, anxiety reduction, and improved sleep quality. Very little is known about CBD and how it functions in the body from both an efficacy and mechanistic perspective, especially in humans. There is a large consumer base for this product that will be expanding exponentially in the next few years. Most of the evidence available is anecdotal from the personal testimony of consumers. 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 selected doses of 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). Our clinical outcomes include measures of muscular pain and disability along with measures of pain-related fear and anxiety. Our laboratory-based study design is desirable and advantageous because it is a controlled method of tracking individuals using an experimental model of injury that is translatable to clinical populations. This exploratory study will provide preliminary data needed to support the hypotheses of a planned larger scale application.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 31 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: a) male and female adults between the ages of 18-35 years and b) English speaking, and c) both female and male subjects must be currently practicing acceptable methods of birth control, such as abstinence, and methods of contraception (barriers, oral, patch or other prophylactic methods).

Exclusion Criteria: a) current use of cannabis products on a regular basis or positive urine test for cannabis, b) current use of tobacco or nicotine containing products on a regular basis, c) currently taking prescription medication for management of anxiety disorders, depression, or ADHD, d) current use of nutritional or dietary supplements on a daily basis (e.g. ephedra, yohimbine, pro-hormones, creatine or anabolics), e) current use of OTC anti-inflammatory medications (e.g. Advil, Aleve, Aspirin) on a regular basis, f) history of seizure disorder, family history of seizure disorder, current or history of head trauma, liver disease, renal (kidney) disease, cardiovascular disease (including, but not limited to: hypotension, hypertension, tachycardia, and syncope), g) current medical condition that would prevent the participant from performing strenuous resistance exercise, h) weight lifting for the lower extremities (legs) more than twice a week, i) currently experiencing pain in the hips, leg, or knee region, j) pregnancy, lactating or positive urine pregnancy test, k) known allergy to CBD or coconut/sesame oil, l) an allergy to tree nuts (coconut).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle-Control (Placebo); (0mg/30mL hemp extract = no hemp extract)	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).
Experimental: Active CBD-extract; Active Dose (2000mg/30mL hemp extract = 67.5mg/day)	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).; Other Names: 2000mg/30mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Anxiety Symptom Scale - 20 (PASS-20)	20 item, 5-point rating scale that assesses 4 theoretically distinct components of pain-related anxiety including cognitive anxiety (items 1 to 5), fear of pain (items 6 to 10), escape/avoidance behavior (items 11 to 15), and physiological anxiety (items 16 to 20). Each subscale is worth 20 points. Subscales are combined to compute total score. The total scale ranges from 0 to 100; higher scores indicate worse outcome.	Pre-exercise (Day 10)
Pain Anxiety Symptom Scale (PASS-20)	20 item, 5-point rating scale that assesses 4 theoretically distinct components of pain-related anxiety including cognitive anxiety (items 1 to 5), fear of pain (items 6 to 10), escape/avoidance behavior (items 11 to 15), and physiological anxiety (items 16 to 20). Each subscale is worth 20 points. Subscales are combined to compute total score. The total scale ranges from 0 to 100; higher scores indicate worse outcome.	Post-exercise (Day 15)
Pain Catastrophizing Scale (PCS)	13-item, 5-point rating scale used to assess different thoughts that may be associated with experiencing pain. The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. The PCS subscales are computed by summing the responses to the following items: Rumination: Sum of items 8, 9, 10, 11; Magnification: Sum of items 6, 7, 13; and Helplessness: Sum of items 1, 2, 3, 4, 5, 12; higher scores indicate worse outcome.	Baseline (Day 1)
Pain Catastrophizing Scale (PCS)	13-item, 5-point rating scale used to assess different thoughts that may be associated with experiencing pain. The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. The PCS subscales are computed by summing the responses to the following items: Rumination: Sum of items 8, 9, 10, 11; Magnification: Sum of items 6, 7, 13; and Helplessness: Sum of items 1, 2, 3, 4, 5, 12; higher scores indicate worse outcome.	Pre-exercise (Day 10)
Pain Catastrophizing Scale (PCS)	13-item, 5-point rating scale used to assess different thoughts that may be associated with experiencing pain. The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. The PCS subscales are computed by summing the responses to the following items: Rumination: Sum of items 8, 9, 10, 11; Magnification: Sum of items 6, 7, 13; and Helplessness: Sum of items 1, 2, 3, 4, 5, 12; higher scores indicate worse outcome.	Post-exercise (Day 15)
Fear of Pain Questionnaire (FPQ-9)	9-item, 5-point rating scale to quantify fear of specific situations that normally produce pain. Each subscale contains 3 items, so the possible range of scores for each subscale is 3 through 15. Subscales are combined to compute total score. The Total score has a range of 9 through 45; higher scores indicate worse outcome.	Baseline (Day 1)
Fear of Pain Questionnaire (FPQ-9)	9-item, 5-point rating scale to quantify fear of specific situations that normally produce pain. Each subscale contains 3 items, so the possible range of scores for each subscale is 3 through 15. Subscales are combined to compute total score. The Total score has a range of 9 through 45; higher scores indicate worse outcome.	Pre-exercise (Day 10)
Maximal Voluntary Isometric Contraction (MVIC)	maximum voluntary force produced during a static muscle contraction	Pre-exercise (Day 10)
Maximal Voluntary Isometric Contraction (MVIC)	maximum voluntary force produced during a static muscle contraction measured in Newton-meters.	Post-exercise (Day 12)
Maximal Voluntary Isometric Contraction (MVIC)	maximum voluntary force produced during a static muscle contraction measured as Newton-meters.	Post-exercise (Day 15)

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Consortium for Medical Marijuana Clinical Outcomes Research
• Investigators: Principal Investigator: Paul Borsa, PhD, ATC, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): March 21, 2024
• Study Completion (Actual): March 21, 2024

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: IRB201903330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes