Optic

ID

Name

IRB20-0112

Description

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.

Trial arms

Trial start

2020-03-10

Estimated PCD

2021-05-01

Trial end

2021-05-01

Status

Completed

Phase

Early phase I

Treatment

Dextrose

Administering dextrose to healthy volunteers for our placebo group

Arms:

Placebo

Dronabinol

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.

Arms:

7.5 mg THC

Dronabinol

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.

Arms:

15 mg THC

Size

24

Primary endpoint

Change From Baseline in Profile of Mood States (POMS)

Through Study Completion, an average of 3 weeks (Baseline - time 0 to Time point 9 (Study Completion))

Eligibility criteria

Inclusion Criteria: * 18-20 years old OR 30-40 years old * Body Mass Index 19-26 * High school education, fluent in English * Occasional cannabis users ( 0 times in past 30 days AND used cannabis no more than 20 times in lifetime) Exclusion Criteria: * History of daily cannabis use * Past or present severe substance use disorder * Current or past diagnosis with drug treatment for psychosis/bipolar/schizophrenia * Cardiovascular illness, high blood pressure, abnormal electrocardiogram * Current medications * Pregnant or planning to become pregnant

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

Updated at

2023-11-09

Organization

University of Chicago

Product

Indication

Indication

Indication

Product

Age-Related Effects of THC