Topical Cannabidiol Cream and Post-exercise Recovery

NCT05044936 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: CBD2021
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This proposal's objective is to investigate the effects of topical cannabidiol (CBD) cream on exercise-induced muscle damage, exercise-induced inflammatory markers, and subsequent exercise performance after an exercise-induced damage protocol.

Conditions

Muscle Damage

Keywords

Exercise; Resistance training; Canabidiol

Outcome Measures

Primary Outcomes (6)

• Change in indirect markers of muscle damage

  Measuring lactate dehydrogenase blood levels

  24 & 48 hours post-training

• Change in indirect markers of muscle damage

  Measuring creatine kinase blood levels

  24 & 48 hours post-training

• Change in muscle soreness

  Measuring using a soreness visual analog scale from 0-10, where 0 means no soreness, and 10 means extremely high/painful levels of soreness

  24 & 48 hours post-training

• Change in exercise performance

  Measure differences in maximum voluntary contraction.

  24 & 48 hours post-training

• Change in exercise performance

  Measure differences in vertical jump

  24 & 48 hours post-training

• Change in exercise performance

  Measure differences in sprint time

  24 & 48 hours post-training

Study Arms (1)

Training

EXPERIMENTAL

Visit 1: sign consent form, pregnancy tests for females, resting blood pressure, height/weight, body composition, and VO2max test. Visit 2: 1-repetition maximum (RM) test and protocol familiarization. Visit 3: perform a muscle-damaging exercise protocol. Pre-exercise soreness and blood samples will be collected. After, they will perform the pre-exercise testing to assess baselines levels of power and sprint times. Upon completion, they will undergo the muscle-damaging exercise protocol. Post-exercise blood samples and soreness will be collected. The participant will then be given either placebo or CBD cream to rub into their quadriceps. Visit 4 \& 5: collect blood samples and soreness scale measurements. Participants will then be given the same treatment (placebo or CBD cream) as they had on visit 3. Visit 6 will be similar to visit 3, except the participant will be given the opposite treatment (placebo or CBD cream). Visits 7 \& 8 will be similar to visits 4 \& 5, respectively.

Drug: Cannabidiol Oil; Other: Resistance Exercise

Interventions

Cannabidiol Oil DRUG

The dose that will be used for each administration of CBD will be 0.5mg/kg of body mass. As there are no recommendations for CBD from the FDA or through previous research in humans, and especially for CBD cream, the dosage is based on the United Kingdom's governing body recommending maximal amounts of CBD ingestion being 1 mg/kg per day. Further, the "practical" amount that companies "recommend" is anywhere from a "pea size" to a "handful," which can range from high and low amounts. Using 0.5mg/kg of body mass allows for a moderate use of the lotion, as well as leaving extra quantities throughout the day should people want to use CBD outside of their post-workout recovery strategies outside of a laboratory setting. To convert the amount of CBD to the amount of lotion, we will divide the amount of CBD (0.5 mg/kg) by 4.85 (the amount of mg of CBD per gram of lotion). This will calculate the amount (in grams) of lotion each participant will receive.

Also known as: CBD

Training

Resistance Exercise OTHER

Participants will complete eccentric-based leg press (4-s lowering phase and 1-s upward phase) for 10 sets of 8 repetitions at 70% 1RM in order to induce muscle damage using a leg press machine. Three minutes of rest will be permitted between sets. Following the 10th leg press, participants will complete 4 sets of 20 consecutive plyometric lunges using only their body weight. Two minutes of rest will be permitted between sets. The muscle damaging protocol will be done upon completion of the 4th set of plyometric lunges.

Also known as: Exercise

Training

Eligibility Criteria

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

You may qualify if:

• Healthy, recreationally trained young adult-aged females and males
• Been engaging in resistance training (\> 2 days/weeks for \> 6 months)
• Classified as "low risk" according to criteria put forth by American College of Sports Medicine

You may not qualify if:

• Cardiovascular, metabolic, viral, kidney, liver disease, or acute orthopedic injuries
• Pregnant or planning to become pregnant during the study
• Unable to consent
• Under 18 years of age
• Over 35 years of age
• Prisoners
• Participants with cognitive impairment or with legally authorized representative

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

UNM Exercise Physiology Lab

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (11)

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  PMID: 29114823 BACKGROUND

• Burstein S. Cannabidiol (CBD) and its analogs: a review of their effects on inflammation. Bioorg Med Chem. 2015 Apr 1;23(7):1377-85. doi: 10.1016/j.bmc.2015.01.059. Epub 2015 Feb 7.

  PMID: 25703248 BACKGROUND

• Cavuoto P, McAinch AJ, Hatzinikolas G, Cameron-Smith D, Wittert GA. Effects of cannabinoid receptors on skeletal muscle oxidative pathways. Mol Cell Endocrinol. 2007 Mar 15;267(1-2):63-9. doi: 10.1016/j.mce.2006.12.038. Epub 2006 Dec 21.

  PMID: 17270342 BACKGROUND

• Clarkson PM, Nosaka K, Braun B. Muscle function after exercise-induced muscle damage and rapid adaptation. Med Sci Sports Exerc. 1992 May;24(5):512-20.

  PMID: 1569847 BACKGROUND

• Cochrane-Snyman KC, Cruz C, Morales J, Coles M. The Effects of Cannabidiol Oil on Noninvasive Measures of Muscle Damage in Men. Med Sci Sports Exerc. 2021 Jul 1;53(7):1460-1472. doi: 10.1249/MSS.0000000000002606.

  PMID: 33481484 BACKGROUND

• Fatouros IG, Jamurtas AZ. Insights into the molecular etiology of exercise-induced inflammation: opportunities for optimizing performance. J Inflamm Res. 2016 Oct 21;9:175-186. doi: 10.2147/JIR.S114635. eCollection 2016.

  PMID: 27799809 BACKGROUND

• Hammell DC, Zhang LP, Ma F, Abshire SM, McIlwrath SL, Stinchcomb AL, Westlund KN. Transdermal cannabidiol reduces inflammation and pain-related behaviours in a rat model of arthritis. Eur J Pain. 2016 Jul;20(6):936-48. doi: 10.1002/ejp.818. Epub 2015 Oct 30.

  PMID: 26517407 BACKGROUND

• Iannotti FA, Pagano E, Moriello AS, Alvino FG, Sorrentino NC, D'Orsi L, Gazzerro E, Capasso R, De Leonibus E, De Petrocellis L, Di Marzo V. Effects of non-euphoric plant cannabinoids on muscle quality and performance of dystrophic mdx mice. Br J Pharmacol. 2019 May;176(10):1568-1584. doi: 10.1111/bph.14460. Epub 2018 Sep 9.

  PMID: 30074247 BACKGROUND

• Mechoulam R, Hanus L. Cannabidiol: an overview of some chemical and pharmacological aspects. Part I: chemical aspects. Chem Phys Lipids. 2002 Dec 31;121(1-2):35-43. doi: 10.1016/s0009-3084(02)00144-5.

  PMID: 12505688 BACKGROUND

• Peres FF, Lima AC, Hallak JEC, Crippa JA, Silva RH, Abilio VC. Cannabidiol as a Promising Strategy to Treat and Prevent Movement Disorders? Front Pharmacol. 2018 May 11;9:482. doi: 10.3389/fphar.2018.00482. eCollection 2018.

  PMID: 29867488 BACKGROUND

• Taylor L, Gidal B, Blakey G, Tayo B, Morrison G. A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Dose, and Food Effect Trial of the Safety, Tolerability and Pharmacokinetics of Highly Purified Cannabidiol in Healthy Subjects. CNS Drugs. 2018 Nov;32(11):1053-1067. doi: 10.1007/s40263-018-0578-5.

  PMID: 30374683 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Cannabidiol; Resistance Training; Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Fabiano Amorim, PhD

  University of New Meixoco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Repeated Measures

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: September 16, 2021
• Study Start: May 15, 2023
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)