Status:
COMPLETED
Investigation of the Pharmacokinetic Profile of CBD
Lead Sponsor:
Yasmin Hurd
Conditions:
Opioid Use Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 pharmacoki...
Detailed Description
The goal of this study is to determine the pharmacokinetics and pharmacodynamic profile of CBD in normal healthy individuals under standard and high fat fed conditions. CBD has recently gained signif...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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.
- 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.
Key Trial Info
Start Date :
May 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05269706
Start Date
May 18 2022
End Date
February 16 2023
Last Update
February 14 2025
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029