CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 14 enrolled
Drug / intervention
dl-Methylphenidate plus Cannabidiol +1 moredrug
Likely dose
dl-Methylphenidate plus Cannabidiol 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04603391
NCT04603391Phase 4Completed

An Assessment of the Drug Interaction Potential Between Oral Cannabidiol (Epidiolex®) and the CES1 Substrate Methylphenidate in Healthy Volunteers

University of Florida·interventional·Posted Oct 26, 2020·Updated Jul 18, 2024

In Brief

A Phase 4 clinical trial evaluating dl-Methylphenidate plus Cannabidiol and dl-Methylphenidate plus Cannabidiol Placebo solution for Drug Interaction. Completed, enrolled 14 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedOct 26, 2020
Enrollment StartFeb 25, 2021
Primary CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.7 years ago

Interventions

dl-Methylphenidate plus Cannabidioldrug

Subjects will be administered one 10 mg tablet of dl-methylphenidate (Ritalin®) plus 7.5 mL Epidiolex® solution

dl-Methylphenidate plus Cannabidiol Placebo solutiondrug

Subjects will be administered one 10 mg tablet of dl-methylphenidate (Ritalin®) plus 7.5 mL of Epidiolex® placebo solution