Investigation of the Pharmacokinetic Profile of CBD

ID#: NCT05023070

Age: 18 - 65 years

Gender: All

Healthy Subjects: Accepts Healthy Volunteers

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: July 22, 2021

End Date: December 31, 2022

Contact Information:
Yasmin Hurd
(212) 585-4662
Summary: The goal of the current study is to evaluate the bioavaibiltiy of CBD in normal healthy Individuals. This is an open cross-over design study in healthy individuals to assess the safety and pharmacokinetic (PK) effects of cannabidiol.

Inclusion Criteria:

1. Ability to understand and give informed consent;

2. Individuals between 18 and 65 years old; Sex is used a biological factor (50% of individuals recruited will be females, allowing sex comparisons).

3. English speakers.

4. 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.

5. Healthy volunteers who are medication- and drug-free, including free from nicotine and any prescribed medications.

Exclusion Criteria:

1. 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

2. 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);

3. Positive urine drug screen (cocaine, opiates, benzodiazepines, barbiturates, amphetamines, morphine, methadone, methamphetamines, oxycodone, phencyclidine, tricyclic antidepressant, tetrahydrocannabinol, buprenorphine, methylenedioxymethamphetamine, propoxyphene);

4. Having a history of hypersensitivity to cannabinoids or any of the ingredients in the product (gelatin and/or sesame oil);

5. Being pregnant or breastfeeding;

6. 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);

7. Participating in another pharmacotherapeutic trial in the past 3 months;

8. History of impaired renal function or elevated liver enzymes at prescreening. The exclusionary lab values are: 3x nl AST/ALT, 1.5x bilirubin or 50% reduction in eGFR.

9. 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.