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Phase 2 N=34 Randomized Triple-blind Treatment

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

Muscle Injury · Recovery · Pain Relief

Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Self-report Ratings of Muscle Soreness — 0.0; 0.0 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Active CBD (Drug); Vehicle Control (Placebo) (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of Florida
Primary completion
Mar 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Self-report Ratings of Muscle Soreness
47.8; 61.6
PRIMARY
Self-report Ratings of Muscle Soreness
47.8; 61.6
PRIMARY
Self-report Ratings of Muscle Soreness
47.8; 61.6
PRIMARY
Self-report Ratings of Disability
67.7; 60.1
PRIMARY
Self-report Ratings of Disability
67.7; 60.1
PRIMARY
Self-report Ratings of Disability
67.7; 60.1
SECONDARY
Pain Anxiety Symptom Scale - 20 (PASS-20)
39.5; 49.9
SECONDARY
Pain Anxiety Symptom Scale (PASS-20)
39.1; 47.9
SECONDARY
Pain Catastrophizing Scale (PCS)
21.4; 23.9
SECONDARY
Pain Catastrophizing Scale (PCS)
21.4; 23.9
SECONDARY
Pain Catastrophizing Scale (PCS)
21.4; 23.9
SECONDARY
Fear of Pain Questionnaire (FPQ-9)
21.5; 18.8
SECONDARY
Fear of Pain Questionnaire (FPQ-9)
21.5; 18.8
SECONDARY
Maximal Voluntary Isometric Contraction (MVIC)
128.4; 121.0
SECONDARY
Maximal Voluntary Isometric Contraction (MVIC)
128.4; 121.0
SECONDARY
Maximal Voluntary Isometric Contraction (MVIC)
128.4; 121.0

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.

Eligibility Criteria

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).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04586712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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