Cannabidiol and Autonomic Function at Rest

NCT04731779 | Completed Early Phase 1

• 1 other identifier: VRBN Pilot 2021_Corcoran
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Cannabidiol (CBD) is one of 700 chemicals derived from the Cannabis sativa plant and is both legal and widespread for distribution in the state of Vermont. The central hypothesis of this proposal is that in apparently healthy adults, acute CBD favorably affects the autonomic nervous system and that this will be evident by an increase in heart rate variability. The overall goal is to understand how CBD affects the autonomic and cardiovascular systems at rest, and when perturbed. The investigators will study a narrow age range of adults, administer varying acute doses of CBD, characterize baseline cardiovascular variables, and record responses to autonomic challenge maneuvers. This will provide the framework to assess potential therapies and/or risk factors of CBD, particularly as it relates to healthy individuals. More information that is so widely taken, especially one that targets receptors known to be involved in cardiovascular signaling pathways is imperative.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

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

  Time-domain measurements quantify the amount of variability of the heart's interbeat (RR) intervals and include the metric: standard deviation of RR intervals (SDNN). Higher values indicate greater HRV.

  4 weeks

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

  Time-domain measurements quantify the amount of variability of the heart's interbeat (RR) intervals and include the metric: root mean square of successive differences (RMSSD). Higher values indicate greater HRV.

  4 weeks

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

  Frequency-domain measurements estimate the distribution of absolute or relative power into four heart rate oscillation frequency bands: ultra-low-frequency (ULF), very-low-frequency (VLF), low-frequency (LF) and high-frequency (HF). A high HF reflects parasympathetic dominance.

  4 weeks

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

  Frequency-domain measurements estimate the distribution of absolute or relative power into four heart rate oscillation frequency bands: ultra-low-frequency (ULF), very-low-frequency (VLF), low-frequency (LF) and high-frequency (HF). LF reflects both sympathetic and parasympathetic activity.

  4 weeks

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

  A low LF/HF ratio reflects parasympathetic dominance, whereas a high LF/HF ratio reflects sympathetic dominance.

  4 weeks

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

  Responses to autonomic stress test include a change in blood pressure if sympathetic outflow is activated. The magnitude of change will be compared before and after CBD ingestion.

  1 day

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

  Responses to autonomic stress test include a change in heart rate if parasympathetic outflow is activated. The magnitude of change will be compared before and after CBD ingestion.

  1 day

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants will ingest 3ml of non-CBD containing MCT (medium-chain triglycerides) oil.

Drug: Placebo

25 mg

EXPERIMENTAL

Participants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 25 mg of CBD.

Drug: cannabidiol

50 mg

EXPERIMENTAL

Participants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 50 mg of CBD.

Drug: cannabidiol

200 mg

EXPERIMENTAL

Participants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 200 mg of CBD.

Drug: cannabidiol

Interventions

cannabidiol DRUG

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

Also known as: CBD

200 mg; 25 mg; 50 mg

Placebo DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female, 18-35 years of age.
• Participants must agree to fast and abstain from food or beverages containing alcohol, caffeine, or CBD for 12 hours prior to each experimental session.
• Completion of Health History Questionnaire with report indicating overall good health.
• The ability to comprehend and satisfactorily comply with protocol requirements.
• Written informed consent given prior to beginning the study.

You may not qualify if:

• Current medications that might influence the cardiovascular and/or autonomic systems.
• Women who are pregnant or lactating.
• Participants who have a history of adverse reactions to cannabidiol will be excluded.

Sponsors & Collaborators

• Castleton University: lead

Study Sites (1)

Castleton University, Jeffords Science Building

Castleton, Vermont, 05735, United States

Location

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Exercise Science

Model Details: Each participant will receive a different dose in consecutive weeks (4 doses total, one of which is a placebo), thus serving as their own control.

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 1, 2021
• Study Start: August 30, 2021
• Primary Completion: November 29, 2021
• Study Completion: November 29, 2021
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)