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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

Primary Purpose

Muscle Injury, Recovery, Pain Relief

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
High dose CBD
Low Dose CBD
Vehicle Control Group
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Injury

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Active CBD-extract high dose

Active CBD low dose

Vehicle-Control (Placebo)

Arm Description

High Dose (1000mg/30mL hemp extract = 62.5mg/day)

Low Dose (500mg/30mL hemp-extract = 25mg/day)

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 6, 2020
Last Updated
April 18, 2023
Sponsor
University of Florida
Collaborators
Consortium for Medical Marijuana Clinical Outcomes Research, SunFlora.Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04586712
Brief Title
Efficacy of a Controlled Short-term Trial of Cannabidiol (CBD) Ingestion on Reducing Symptomatic Response and Facilitating Recovery After Induced Muscle Injury
Official Title
Efficacy of a Controlled Short-term Trial of Cannabidiol (CBD) Ingestion on Reducing Symptomatic Response and Facilitating Recovery After Induced Muscle Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 21, 2024 (Anticipated)
Study Completion Date
March 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Consortium for Medical Marijuana Clinical Outcomes Research, SunFlora.Inc

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Injury, Recovery, Pain Relief

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active CBD-extract high dose
Arm Type
Experimental
Arm Description
High Dose (1000mg/30mL hemp extract = 62.5mg/day)
Arm Title
Active CBD low dose
Arm Type
Experimental
Arm Description
Low Dose (500mg/30mL hemp-extract = 25mg/day)
Arm Title
Vehicle-Control (Placebo)
Arm Type
Placebo Comparator
Arm Description
(0mg/30mL hemp extract = no hemp extract)
Intervention Type
Drug
Intervention Name(s)
High dose CBD
Other Intervention Name(s)
1000mg/30mL (high)
Intervention Description
Participants will be provided a viscous liquid in a bottle with a syringe dropper containing CBD-extract oil at concentrations of 1000mg/30mL (high).
Intervention Type
Drug
Intervention Name(s)
Low Dose CBD
Other Intervention Name(s)
500mg/30mL (low)
Intervention Description
Participants will be provided a viscous liquid in a bottle with a syringe dropper containing CBD oil at concentrations of 500mg/30mL (low)
Intervention Type
Drug
Intervention Name(s)
Vehicle Control Group
Intervention Description
Participants will be provided a viscous liquid in a bottle with a syringe dropper containing placebo containing no CBD oil (0mg/30 mL).
Primary Outcome Measure Information:
Title
Self-report ratings of muscle soreness
Description
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.
Time Frame
Baseline (Day 1)
Title
Self-report ratings of muscle soreness
Description
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.
Time Frame
Pre-exercise (Day 11)
Title
Self-report ratings of muscle soreness
Description
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.
Time Frame
Post-exercise (Days 12-15)
Title
Self-report ratings of Disability
Description
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.
Time Frame
Post-exercise (Days 12-15)
Title
Self-report ratings of Disability
Description
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.
Time Frame
Baseline (Day 1)
Title
Self-report ratings of Disability
Description
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.
Time Frame
Pre-exercise (Day 11)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Borsa, PhD, ATC
Phone
352-294-1726
Email
pborsa@hhp.ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
John Stauffer
Phone
908-616-3886
Email
Johnstauffer@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Borsa, PhD, ATC
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul A. Borsa, PhD, ATC

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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