NCT05232123

Brief Summary

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 Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2023

Typical duration for early_phase_1 healthy

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
1.4 years until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

January 11, 2022

Last Update Submit

March 26, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

  • 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.

    Week 5

  • 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.

    Week 5

  • Maximal oxygen consumption (VO2max)

    Maximum oxygen consumption will be calculated during treadmill test (using the Bruce Protocol)

    8 days

  • Heart rate

    Change in heart rate will be assessed throughout session

    through study completion, an average of 4 weeks

Secondary Outcomes (2)

  • Blood pressure

    through study completion, an average of 4 weeks

  • Borg's Category-Ratio Scale for Rating of Perceived Exertion

    8 days

Other Outcomes (5)

  • Change in oxygen saturation

    8 days

  • Blood lactate

    8 days

  • Change in exercise duration

    8 days

  • +2 more other outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Cannabidiol 25 mg

EXPERIMENTAL

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

Drug: Cannabidiol

Cannabidiol 50 mg

EXPERIMENTAL

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

Drug: Cannabidiol

Cannabidiol 200 mg

EXPERIMENTAL

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

Drug: Cannabidiol

Interventions

PlaceboDRUG

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

Placebo
CannabidiolDRUG

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

Also known as: CBD
Cannabidiol 200 mgCannabidiol 25 mgCannabidiol 50 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female
  • + years (aims 3\&4)
  • + 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Castleton University, Jeffords Science Building

Castleton, Vermont, 05735, United States

Location

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals
0

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
Model Details: Each participant will receive a different dose in consecutive weeks (one of which is a placebo), thus serving as their own control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Exercise Science

Study Record Dates

First Submitted

January 11, 2022

First Posted

February 9, 2022

Study Start

July 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

March 27, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)