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NIDA-CPU-0011

Division
DTMC
HEAL Study
No
Investigator(s)
Louis Cantilena, Jr., M.D, Ph.D.
Title
Ph1 Marinol Interaction Study - Part 1
Short Description
Phase 1 Pilot Study To Examine The Cardiovascular Effects Of Smoked Marijuana, Interactions With Oral Dronabinol, And Effects Of Dronabinol On Withdrawal In Marijuana Dependent Volunteers - Part 1
Release Date
Nov 30, 2022
Description

This study will examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant drug interactions before conducting outpatient studies. Part One is a pilot study to characterize the cardiovascular effects/safety, subjective effects, and PK of smoked marijuana and to familiarize study staff with the conduct of controlled smoking sessions.

Keywords
phase 1a
dronabinol
marijuana
Assessments
Blood Study Agent Level
Marijuana Withdrawal Symptom Checklist
Urine THC Level
Visual Analog Scales
Vital Signs Monitoring
Accessibility Notice

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Study Links
ClinicalTrials.gov Link
CPU-0011 in NIH clinical trials registry