Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04586712
Other study ID # IRB201903330
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 1, 2021
Est. completion date March 21, 2024

Study information

Verified date April 2023
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to determine the efficacy of a controlled short-term trial of CBD ingestion for reducing symptomatic response and facilitating recovery following induced muscle injury. A double-blind, randomized, three-arm study design will be used and participants will be randomly assigned to either a high dose (n=15), low 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.


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. In addition, we aim to identify if the effects are dose-dependent by utilizing a low-dose (25 mg/day), high-dose (62.5 mg/day) and vehicle-control (0 mg/day) ingestion regimen. 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 will be administered orally during a 15-day pre-injury consumption and post-injury recovery phase. A double-blind, randomized, three-arm study design will be used and participants will be randomly assigned to either a high dose (n=15), low 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. Another advantage of this study design is that it will address, in parallel fashion, two of the primary reasons people are consuming CBD - symptomatic relief and anxiety reduction. This exploratory study will provide preliminary data needed to support the hypotheses of a planned larger scale application.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date March 21, 2024
Est. primary completion date March 21, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).
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).

Locations

Country Name City State
United States University of Florida Gainesville Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Florida Consortium for Medical Marijuana Clinical Outcomes Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 11)
Primary 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. Post-exercise (Days 12-15)
Primary 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 (Days 12-15)
Primary 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)
Primary 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 11)
See also
  Status Clinical Trial Phase
Completed NCT03708692 - Menstrual Cycle Phases on Recovery and Cognitive Function
Completed NCT06012747 - Pain After Cesarean Section - A Danish Multicenter Cohort Study.
Recruiting NCT04049942 - Comparing the Impact of Multimodal Prehabilitation to Aerobic Training on Patients Undergoing Thoracoscopic Lobectomy N/A
Completed NCT04564300 - The Influence of Oral Contraceptive Use on Muscle Recovery N/A
Active, not recruiting NCT06160869 - Effect of Acceptance and Commitment Therapy on Psychotic Severity N/A
Completed NCT04082728 - Evaluation of the Added Value of Metamizole to Standard Post-operative Treatment After Ambulant Surgery N/A
Completed NCT03775564 - Effectiveness of the RemedRugby Program N/A
Completed NCT01902147 - Postoperative Quality Recovery Scale (PQRS) N/A
Completed NCT05607875 - The Grow to Recovery Train-the-Trainer Program N/A
Completed NCT05097027 - Blood Flow Restriction and Recovery in Soccer Players N/A
Recruiting NCT04549610 - HMB and Exercise-induced Muscle Damage Phase 2/Phase 3
Withdrawn NCT04125225 - What Are the Experiences of Patients With Pseudomyxoma Peritonei?
Recruiting NCT04092504 - Optimized Recovery After Trauma in Geriatric Patient N/A
Completed NCT06112210 - Effect of Hyperbaric Oxygen Therapy N/A
Active, not recruiting NCT06440343 - Effects of Acute Carbohydrate Intake Intra-training in Crosstraining N/A
Completed NCT05998590 - Pre-sleep Protein Supplementation in British Army Recruits N/A
Active, not recruiting NCT05984186 - Wingate-type Exercise Test to Evaluate the Effect of High Velocity Therapy on Recovery Sensation and Blood Lactate Decline
Recruiting NCT04297852 - The Function of Nutrition Rich Vegan Drink on Inflammatory Bowel Disease N/A
Completed NCT06206798 - Resourcefulness Group Intervention on Recovery and Quality of Life N/A
Completed NCT02132481 - Using Smartphones to Provide Recovery Support Services N/A