CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 24 enrolled
Drug / intervention
Dextrose +2 moredrug
Likely dose
Dronabinol 7.5 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/NCT04294966
NCT04294966Early Ph 1Completed

Age-Related Effects of THC

University of Chicago·interventional·Posted Mar 4, 2020·Updated Nov 9, 2023

In Brief

A Early Phase 1 clinical trial evaluating Dextrose and Dronabinol for Tolerance and 2 related conditions. Completed, enrolled 24 participants across 2 sites.

Detailed Summary

Increased accessibility to cannabis and its primary psychoactive constituent THC has raised public health concerns. One major concern surrounds the potential risks associated with acute THC intoxication and who might be most at risk. A second major concern is the need to develop sensitive measures that can detect THC intoxication after recent use and enable robust comparisons of intoxication to determine sources of risk. One potential source of risk is age, specifically during the period of adolescence.

Study Details

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

Timeline

Early Ph 1CompletedFinished
2020202120222023202420252026
First PostedMar 4, 2020
Enrollment StartMar 10, 2020
Primary CompletionMay 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 6.3 years ago

Interventions

Dextrosedrug

Administering dextrose to healthy volunteers for our placebo group

Dronabinoldrug

THC (Marinol® \[dronabinol\]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users.

Dronabinoldrug

THC (Marinol® \[dronabinol\]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users.