Clinical trial

Cannabidiol Effects on Cardiovascular System and Exercise Responses

Name

VBRN Project 2022_Corcoran

Description

To identify the autonomic effects of recreationally-relevant doses of cannabidiol (CBD) in an older population, and to evaluate the effect of CBD on exercise performance and recovery.

Trial arms

Trial start

2023-07-01

Estimated PCD

2024-12-01

Trial end

2024-12-01

Status

Withdrawn

Phase

Early phase I

Treatment

Placebo

Placebo oral product formulated in MCT (medium chain triglyceride) oil

Arms:

Placebo

Cannabidiol

Cannabidiol oral product formulated in MCT (medium chain triglyceride) oil

Arms:

Cannabidiol 200 mg, Cannabidiol 25 mg, Cannabidiol 50 mg

Other names:

CBD

Primary endpoint

Change in heart rate variability (HRV) as assessed by time-domain analysis: standard deviation of RR intervals.

4 weeks

Change in heart rate variability (HRV) as assessed by time-domain analysis: root mean square of successive differences.

4 weeks

Change in heart rate variability (HRV) as assessed by frequency-domain analysis: high-frequency (HF).

4 weeks

Change in heart rate variability (HRV) as assessed by frequency-domain analysis: low-frequency (LF).

4 weeks

Change in heart rate variability (HRV) as assessed by frequency-domain analysis: LF/HF ratio.

4 weeks

Change in magnitude of autonomic stress test responses as assessed by changes in blood pressure.

Week 5

Change in magnitude of autonomic stress test responses as assessed by changes in heart rate.

Week 5

Maximal oxygen consumption (VO2max)

8 days

Heart rate

through study completion, an average of 4 weeks

Eligibility criteria

Inclusion Criteria: * male or female * 18+ years (aims 3\&4) * 50+ years (aims 1\&2) * participants must agree to fast for 4 hours and abstain from food or beverages containing alcohol, caffeine, or CBD for 12 hours prior to each experimental session * participants must agree to avoid exercise for 6 hours prior to each experimental session * completion of Health History Screening Questionnaire with report indicating overall good health * ability to comprehend and satisfactorily comply with protocol requirements * written informed consent given prior to study participation * low-risk for VO2max testing (aims 3\&4) Exclusion Criteria: * women who are pregnant or lactating * participants who have a history of adverse reactions to cannabidiol * current medications that might influence the cardiovascular and/or autonomic systems * any cardiac, pulmonary, renal, or metabolic disease * walking difficulty (aims 3\&4) * waiting for a stress test for a medical reason (aims 3\&4) * medical contraindication to performing a treadmill stress test (aims 3\&4)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each participant will receive a different dose in consecutive weeks (one of which is a placebo), thus serving as their own control.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

Updated at

2024-03-27

1 organization

2 drugs

1 indication

Organization

Drug

Indication

Drug