Trial Outcomes & Findings for Efficacy of a Controlled Short-term Trial of Cannabidiol (CBD) Ingestion on Reducing Symptomatic Response and Facilitating Recovery After Induced Muscle Injury (NCT NCT04586712)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Baseline (Day 1)

Results posted on

2025-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	Active CBD-extract Active Dose (2000mg/30mL hemp extract = 67.5mg/day) 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) (0mg/30mL hemp extract = no hemp extract) 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).
Overall Study STARTED	17	17
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active CBD-extract n=15 Participants Active Dose (2000mg/30mL hemp extract = 67.5mg/day) 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) n=14 Participants (0mg/30mL hemp extract = no hemp extract) 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).	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=93 Participants	14 Participants n=4 Participants	29 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	20.1 years STANDARD_DEVIATION 1.4 • n=93 Participants	19.8 years STANDARD_DEVIATION 1.6 • n=4 Participants	20.0 years STANDARD_DEVIATION 1.5 • n=27 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	10 Participants n=4 Participants	20 Participants n=27 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	4 Participants n=4 Participants	9 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=93 Participants	13 Participants n=4 Participants	25 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	8 Participants n=93 Participants	9 Participants n=4 Participants	17 Participants n=27 Participants
Race (NIH/OMB) More than one race	6 Participants n=93 Participants	5 Participants n=4 Participants	11 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	15 participants n=93 Participants	14 participants n=4 Participants	29 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1)

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.

Outcome measures

Outcome measures
Measure	Active CBD-extract n=15 Participants Active Dose (2000mg/30mL hemp extract = 67.5mg/day) 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) n=13 Participants (0mg/30mL hemp extract = no hemp extract) 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).
Self-report Ratings of Muscle Soreness	0.0 score on a scale Standard Deviation 0	0.0 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: Pre-exercise (Day 10)

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.

Outcome measures

Outcome measures
Measure	Active CBD-extract n=15 Participants Active Dose (2000mg/30mL hemp extract = 67.5mg/day) 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) n=13 Participants (0mg/30mL hemp extract = no hemp extract) 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).
Self-report Ratings of Muscle Soreness	4.0 score on a scale Standard Deviation 7.4	2.3 score on a scale Standard Deviation 5.9

PRIMARY outcome

Timeframe: Post-exercise (Day 12)

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.

Outcome measures

Outcome measures
Measure	Active CBD-extract n=15 Participants Active Dose (2000mg/30mL hemp extract = 67.5mg/day) 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) n=13 Participants (0mg/30mL hemp extract = no hemp extract) 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).
Self-report Ratings of Muscle Soreness	47.8 score on a scale Standard Deviation 27.3	61.6 score on a scale Standard Deviation 22.3

PRIMARY outcome

Timeframe: Baseline (Day 1)

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.

Outcome measures

Outcome measures
Measure	Active CBD-extract n=15 Participants Active Dose (2000mg/30mL hemp extract = 67.5mg/day) 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) n=15 Participants (0mg/30mL hemp extract = no hemp extract) 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).
Self-report Ratings of Disability	77.2 score on a scale Standard Deviation 5.4	76.7 score on a scale Standard Deviation 4.6

PRIMARY outcome

Timeframe: Pre-exercise (Day 10)

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.

Outcome measures

Outcome measures
Measure	Active CBD-extract n=15 Participants Active Dose (2000mg/30mL hemp extract = 67.5mg/day) 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) n=15 Participants (0mg/30mL hemp extract = no hemp extract) 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).
Self-report Ratings of Disability	77.1 score on a scale Standard Deviation 4.8	75.9 score on a scale Standard Deviation 5.4

PRIMARY outcome

Timeframe: Post-exercise (Day 12)

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.

Outcome measures

Outcome measures
Measure	Active CBD-extract n=15 Participants Active Dose (2000mg/30mL hemp extract = 67.5mg/day) 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) n=15 Participants (0mg/30mL hemp extract = no hemp extract) 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).
Self-report Ratings of Disability	67.7 score on a scale Standard Deviation 13.2	60.1 score on a scale Standard Deviation 27.4

SECONDARY outcome

Timeframe: Pre-exercise (Day 10)

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.

Outcome measures

Outcome measures
Measure	Active CBD-extract n=15 Participants Active Dose (2000mg/30mL hemp extract = 67.5mg/day) 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) n=13 Participants (0mg/30mL hemp extract = no hemp extract) 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).
Pain Anxiety Symptom Scale - 20 (PASS-20)	39.5 score on a scale Standard Deviation 15.4	49.9 score on a scale Standard Deviation 22.1

SECONDARY outcome

Timeframe: Post-exercise (Day 15)

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.

Outcome measures

Outcome measures
Measure	Active CBD-extract n=15 Participants Active Dose (2000mg/30mL hemp extract = 67.5mg/day) 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) n=13 Participants (0mg/30mL hemp extract = no hemp extract) 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).
Pain Anxiety Symptom Scale (PASS-20)	39.1 score on a scale Standard Deviation 16.9	47.9 score on a scale Standard Deviation 21.4

SECONDARY outcome

Timeframe: Baseline (Day 1)

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.

Outcome measures

Outcome measures
Measure	Active CBD-extract n=15 Participants Active Dose (2000mg/30mL hemp extract = 67.5mg/day) 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) n=13 Participants (0mg/30mL hemp extract = no hemp extract) 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).
Pain Catastrophizing Scale (PCS)	21.1 score on a scale Standard Deviation 6.5	26.4 score on a scale Standard Deviation 11.7

SECONDARY outcome

Timeframe: Pre-exercise (Day 10)

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.

Outcome measures

Outcome measures
Measure	Active CBD-extract n=15 Participants Active Dose (2000mg/30mL hemp extract = 67.5mg/day) 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) n=13 Participants (0mg/30mL hemp extract = no hemp extract) 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).
Pain Catastrophizing Scale (PCS)	21.3 score on a scale Standard Deviation 7.5	25.4 score on a scale Standard Deviation 11.2

SECONDARY outcome

Timeframe: Post-exercise (Day 15)

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.

Outcome measures

Outcome measures
Measure	Active CBD-extract n=15 Participants Active Dose (2000mg/30mL hemp extract = 67.5mg/day) 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) n=13 Participants (0mg/30mL hemp extract = no hemp extract) 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).
Pain Catastrophizing Scale (PCS)	21.4 score on a scale Standard Deviation 10.1	23.9 score on a scale Standard Deviation 10.3

SECONDARY outcome

Timeframe: Baseline (Day 1)

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.

Outcome measures

Outcome measures
Measure	Active CBD-extract n=15 Participants Active Dose (2000mg/30mL hemp extract = 67.5mg/day) 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) n=13 Participants (0mg/30mL hemp extract = no hemp extract) 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).
Fear of Pain Questionnaire (FPQ-9)	23.8 score on a scale Standard Deviation 5.4	21.3 score on a scale Standard Deviation 5.7

SECONDARY outcome

Timeframe: Pre-exercise (Day 10)

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.

Outcome measures

Outcome measures
Measure	Active CBD-extract n=15 Participants Active Dose (2000mg/30mL hemp extract = 67.5mg/day) 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) n=13 Participants (0mg/30mL hemp extract = no hemp extract) 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).
Fear of Pain Questionnaire (FPQ-9)	21.5 score on a scale Standard Deviation 5.0	18.8 score on a scale Standard Deviation 7.1

SECONDARY outcome

Timeframe: Pre-exercise (Day 10)

maximum voluntary force produced during a static muscle contraction

Outcome measures

Outcome measures
Measure	Active CBD-extract n=13 Participants Active Dose (2000mg/30mL hemp extract = 67.5mg/day) 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) n=12 Participants (0mg/30mL hemp extract = no hemp extract) 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).
Maximal Voluntary Isometric Contraction (MVIC)	138.5 Newton-meters Standard Deviation 23.3	129.3 Newton-meters Standard Deviation 42.1

SECONDARY outcome

Timeframe: Post-exercise (Day 12)

maximum voluntary force produced during a static muscle contraction measured in Newton-meters.

Outcome measures

Outcome measures
Measure	Active CBD-extract n=13 Participants Active Dose (2000mg/30mL hemp extract = 67.5mg/day) 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) n=12 Participants (0mg/30mL hemp extract = no hemp extract) 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).
Maximal Voluntary Isometric Contraction (MVIC)	122.4 force output in Newton-meters Standard Deviation 41.2	102.4 force output in Newton-meters Standard Deviation 32.6

SECONDARY outcome

Timeframe: Post-exercise (Day 15)

maximum voluntary force produced during a static muscle contraction measured as Newton-meters.

Outcome measures

Outcome measures
Measure	Active CBD-extract n=13 Participants Active Dose (2000mg/30mL hemp extract = 67.5mg/day) 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) n=12 Participants (0mg/30mL hemp extract = no hemp extract) 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).
Maximal Voluntary Isometric Contraction (MVIC)	128.4 force output in Newton-meters Standard Deviation 50.2	121.0 force output in Newton-meters Standard Deviation 44.7

Adverse Events

Active CBD-extract

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle-Control (Placebo)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Paul Borsa

University of Florida

Phone: 352-294-1726

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place