The Pharmacokinetics and Pharmacodynamics of a Single Acute Dose of a Hemp-derived Oral Product With a 1:1 Ratio of CBD:CBD-A

NCT05049733 | Completed Phase 1 FDA Drug

• 1 other identifier: IRB00290381
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the pharmacokinetics and pharmacodynamics of a hemp-derived oral product containing cannabidiol (CBD) and cannabidiolic acid (CBD-A) at a 1:1 ratio.

Conditions

Cannabis

Outcome Measures

Primary Outcomes (12)

• Pharmacokinetics - maximum concentration (CMax) for CBD

  Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentration (Cmax) is determined as the highest concentration (in nanogram per milliliter, ng/mL) reached for each individual.

  48 hrs

• Pharmacokinetics - maximum concentration (CMax) for CBD-A

  Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentration (Cmax) is determined as the highest concentration (in nanogram per milliliter, ng/mL) reached for each individual.

  48 hrs

• Pharmacokinetics - maximum concentration (CMax) for THC

  Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentration (Cmax) is determined as the highest concentration (in nanogram per milliliter, ng/mL) reached for each individual.

  48 hrs

• Pharmacokinetics - maximum concentration (CMax) for THC-A

  Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentration (Cmax) is determined as the highest concentration (in nanogram per milliliter, ng/mL) reached for each individual.

  48 hrs

• Pharmacokinetics - AUC for CBD

  Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.

  48 hrs

• Pharmacokinetics - AUC for CBD-A

  Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.

  48 hrs

• Pharmacokinetics - AUC for THC

  Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.

  48 hrs

• Pharmacokinetics - AUC for THC-A

  Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.

  48 hrs

• Pharmacokinetics - Tmax for CBD

  Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The Tmax, or time to reach maximum concentration, is the timepoint at which the Cmax is observed.

  48 hrs

• Pharmacokinetics - Tmax for CBD-A

  Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The Tmax, or time to reach maximum concentration, is the timepoint at which the Cmax is observed.

  48 hrs

• Pharmacokinetics - Tmax for THC

  Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The Tmax, or time to reach maximum concentration, is the timepoint at which the Cmax is observed.

  48 hrs

• Pharmacokinetics - Tmax for THC-A

  Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The Tmax, or time to reach maximum concentration, is the timepoint at which the Cmax is observed.

  48 hrs

Secondary Outcomes (5)

• Driving Under the Influence of Drugs (DRUID) application global impairment score

  8 hrs

• Number of Correct Trials on Paced Auditory Serial Addition Task (PASAT)

  8 hrs

• Number of Correct Trials on the Digit Symbol Substitution Task (DSST)

  8 hrs

• Distance from Central Stimulus on the Divided Attention Task (DAT)

  8 hrs

• Feel Drug Effect as assessed by the Drug Effect Questionnaire (DEQ)

  8 hrs

Study Arms (4)

Arm 1

EXPERIMENTAL

Participants will start with ingestion of soft gel tablets high in CBD and CBD-A, but low in THC and THC-A. The total amount of cannabinoids ingested will be 1 mg/kg and then switch to other doses after washout periods.

Drug: CBD 1mg/Kg; Drug: CBD 2mg/Kg; Drug: CBD 4mg/Kg; Drug: Placebo CBD

Arm 2

EXPERIMENTAL

Participants will start with ingestion of soft gel tablets high in CBD and CBD-A, but low in THC and THC-A. The total amount of cannabinoids ingested will be 2 mg/kg and then switch to other doses after washout periods.

Drug: CBD 1mg/Kg; Drug: CBD 2mg/Kg; Drug: CBD 4mg/Kg; Drug: Placebo CBD

Arm 3

EXPERIMENTAL

Participants will start with ingestion of soft gel tablets high in CBD and CBD-A, but low in THC and THC-A. The total amount of cannabinoids ingested will be 4 mg/kg and then switch to other doses after washout periods.

Drug: CBD 1mg/Kg; Drug: CBD 2mg/Kg; Drug: CBD 4mg/Kg; Drug: Placebo CBD

Arm 4

PLACEBO COMPARATOR

Participants will begin with ingestion of placebo soft gel tablets that do not contain cannabinoids and then switch to other doses after washout periods.

Drug: CBD 1mg/Kg; Drug: CBD 2mg/Kg; Drug: CBD 4mg/Kg; Drug: Placebo CBD

Interventions

CBD 1mg/Kg DRUG

Participants will ingest soft gel tablets containing CBD 1mg/Kg

Arm 1; Arm 2; Arm 3; Arm 4

CBD 2mg/Kg DRUG

Participants will ingest soft gel tablets containing CBD 2mg/Kg

Arm 1; Arm 2; Arm 3; Arm 4

CBD 4mg/Kg DRUG

Participants will ingest soft gel tablets containing CBD 4mg/Kg

Arm 1; Arm 2; Arm 3; Arm 4

Placebo CBD DRUG

Participants will ingest soft gel tablets containing placebo for CBD

Arm 1; Arm 2; Arm 3; Arm 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have provided written informed consent
• Be between the ages of 18 and 55
• Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
• Test negative for recent cannabis use in urine at the screening visit and again upon admission for each experimental session
• Test negative for other drugs of abuse, including alcohol, at the screening visit and upon arrival for the experimental session
• Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission
• Weigh between 110 lbs (50 kg) and 220 lbs (100 kg)
• Blood pressure at screening visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
• Self-report prior experience using cannabis or CBD products, but no cannabis, cannabinoid, or hemp product use in the prior 30 days
• Have not donated blood in the prior 30 days
• For women of children bearing potential and men with female partners of child-bearing potential, must be willing to use an effective form of contraception during the study and for at least 30 days after the last drug administration session

You may not qualify if:

• Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the past 30 days
• History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures
• Use of an over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days (or 5 half-lives for that specific drug) of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the participant
• Use of a prescription medication (with the exception of birth control prescriptions) within 14 days (or 5 half-lives for that specific drug) of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the participant. This includes any medication metabolized via CYP2D6, CYP2C9, CYP2B10, or which induce/inhibit CYP3A4 enzymes.
• History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina)
• Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing
• Epilepsy or a history of seizures.
• Individuals with anemia for whom, in the opinion of the study team, participation would pose increased medical risk.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Cultivate Biologics: collaborator

Study Sites (1)

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Tory Spindle, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind (Participant, Outcomes Assessor), placebo controlled
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will complete all dose conditions (study arms) in a randomized order

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 20, 2021
• Study Start: March 7, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)