Investigation of the Pharmacokinetic Profile of CBD

NCT05269706 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: STUDY-19-00681
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the current study is to evaluate the bioavailability of CBD in normal healthy Individuals. This is an open cross-overdesign study in healthy individuals to assess the safety and pharmacokinetic (PK) effects of cannabidiol.

Conditions

Opioid Use Disorder

Keywords

Methadone; Buprenorphine; Opioid Use Disorder

Outcome Measures

Primary Outcomes (3)

• Systematic Assessment for Treatment Emergent Events (SAFTEE)

  Systematic Assessment for Treatment Emergent Events (SAFTEE) to measure safety and adverse events.

  up to 24 hours post-treatment

• Peak Plasma Concentration (Cmax)

  Peak plasma concentration of CBD and its metabolites

  up to 24 hours post-treatment

• Area under the plasma concentration curve (AUC)

  Area under the plasma concentration versus time curve

  up to 24 hours post-treatment

Secondary Outcomes (2)

• Peak urine concentration of CBD (Umax)

  up to 24 hours post-treatment

• Area under the urine concentration curve (AUC)

  up to 24 hours post-treatment

Study Arms (2)

Standard Meal

EXPERIMENTAL

Participants taking a standard meal.

Drug: Cannabidiol 200mg; Drug: Epidiolex; Drug: Cannabidiol 400mg; Drug: Placebo

High Fat Meal

EXPERIMENTAL

Participants taking a high fat meal.

Drug: Cannabidiol 200mg; Drug: Epidiolex; Drug: Cannabidiol 400mg; Drug: Placebo

Interventions

Cannabidiol 200mg DRUG

Cannabidiol 200mg (twice daily)

Also known as: BSPG CBD

High Fat Meal; Standard Meal

Epidiolex DRUG

Epidiolex 400mg (twice daily)

High Fat Meal; Standard Meal

Cannabidiol 400mg DRUG

Cannabidiol 400mg (twice daily)

Also known as: BSPG CBD

High Fat Meal; Standard Meal

Placebo DRUG

Matching Placebo (Twice Daily)

High Fat Meal; Standard Meal

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and give informed consent;
• Individuals between 18 and 65 years old; Sex is used a biological factor (50% of individuals recruited will be females, allowing sex comparisons).
• English speakers.
• Being healthy as determined by study physician according to screening medical and psychiatric history, physical examination, vitals, ECG and safety laboratory values. Only healthy volunteers with normal hepatic laboratory values will be enrolled.
• Healthy volunteers who are medication- and drug-free, including free from nicotine and any prescribed medications.

You may not qualify if:

• Having present or past medical conditions, including a DSM-5 Axis I psychiatric disorder, history of cardiac disease, arrhythmias, neurological disease of central origin, head trauma, and seizures
• Using any psychoactive drug (other than nicotine) in at least the past 7 days (determined by lack of acute-opioid or other drugs related withdrawal symptoms and the negative result of a urine drug screen including an opioid drug metabolite test, and alcohol breathalyzer to detect alcohol intoxication);
• Positive urine drug screen (cocaine, opiates, benzodiazepines, barbiturates, amphetamines, morphine, methadone, methamphetamines, oxycodone, phencyclidine, tricyclic antidepressant, tetrahydrocannabinol, buprenorphine, methylenedioxymethamphetamine, propoxyphene);
• Having a history of hypersensitivity to cannabinoids or any of the ingredients in the product (gelatin and/or sesame oil);
• Being pregnant or breastfeeding;
• Not using an appropriate method of contraception such as hormonal contraception (oral hormonal contraceptives, Depo-Provera, Nuva-Ring), intrauterine device (IUD), sterilization, or double barrier method (combination of any two barrier methods used simultaneously, i.e. condom, spermicide, diaphragm);
• Participating in another pharmacotherapeutic trial in the past 3 months;
• Participants who have used any medication, dietary supplements (and/or grape fruit juice), or combination of medications and supplements known to alter the metabolism of, or interact with CBD (bupropion, rifampin, barbiturates, phenothiazines, cimetidine, etc.) 14 days prior to and during the duration of the study.

Sponsors & Collaborators

• Yasmin Hurd: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Yasmin Hurd, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Study will be conducted using a cross-over design, separated by a 1-week washout period.

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 8, 2022
• Study Start: May 18, 2022
• Primary Completion: February 16, 2023
• Study Completion: February 16, 2023
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

US (1)