NCT04294966

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

March 10, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

November 9, 2023

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

February 27, 2020

Results QC Date

April 20, 2022

Last Update Submit

November 6, 2023

Conditions

ToleranceAdolescent BehaviorTHC

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Profile of Mood States (POMS)

    The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS consists of 72 mood adjectives rated on a Likert scale from 0 (not at all) to 4 (extremely), divided into 8 subscales: Friendliness, Anxiety, Elation, Anger, Fatigue, Depression, Confusion and Vigor, and two composite scales: Positive Mood (Elation minus Depression) and Arousal (Vigor plus Anxiety minus Confusion plus Fatigue). Scoring of this instrument provides a global score of 0 to 120 or individual domain scores of 0 to 20. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.

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

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Drug: Dextrose

7.5 mg THC

ACTIVE COMPARATOR
Drug: Dronabinol

15 mg THC

ACTIVE COMPARATOR
Drug: Dronabinol

Interventions

DextroseDRUG

Administering dextrose to healthy volunteers for our placebo group

Placebo
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.

7.5 mg THC

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Chicago Hospital

Chicago, Illinois, 60637, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Adolescent Behavior

Interventions

GlucoseDronabinol

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesCannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Harriet de Wit
Organization
University of Chicago
dewitlab@yoda.bsd.uchicago.edu
7737023560

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2020

First Posted

March 4, 2020

Study Start

March 10, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

November 9, 2023

Results First Posted

November 9, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)