Cannabidiol and CES1 Interactions in Healthy Subjects

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The proposed study will assess the drug interaction potential between oral cannabidiol (Epidiolex®) and the carboxylesterase 1 (CES1) substrate methylphenidate (Ritalin®) in 12 healthy research subjects

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Florida
• Collaborator: State of Florida Consortium for Medical Marijuana Clinical Outcomes Research
• Treatments: Cannabidiol; Epidiolex; Methylphenidate

Criteria

Inclusion Criteria:

• Signed Informed Consent

• Age: 21-45 years

• Gender: males and females (50:50)

• Race or ethnicity: no restrictions

• Body Mass Index (BMI) between 18.5 to 28 kg/m2 (inclusive)

• Satisfactory completion of the screening medical history, physical exam, and laboratory evaluations.

• Females of child-bearing potential must have a negative urine pregnancy test prior to enrollment and avoid pregnancy during study participation.

• With the exception of oral contraceptives, subjects must not be taking prescription or OTC medication for the duration of study participation

• Subjects must have no ongoing use of any botanical/nutritional supplement, vitamin, or energy drink for the duration of study participation

Exclusion Criteria:

• The presence of a known allergy, hypersensitivity, or adverse reaction to CBD or cannabis, or sesame seed oil

• The presence of a known allergy, hypersensitivity, or adverse reaction to methylphenidate or dexmethylphenidate (Focalin®)

• A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurologic disease will render subjects ineligible for the study.

• The presence of any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion including;

1. Gastric bezoar

2. Swallowing disorders

3. Strictures

4. Fistulas

5. GI obstruction

6. Severe dsyphasgia

7. Crohn's disease

8. Diverticulitis

9. A positive urine pregnancy test.

10. A positive Urine Drug Screen

11. Any concomitant prescription medication, OTC medication, herbal or other dietary supplement or vitamins during the study period.

All subjects must be medication-free from 7 Days before initiation of the first active study day, through the duration of the study. This exclusion the use of vitamins, herbal preparations and OTC supplements.