Age-Related Effects of THC

Adolescent Behavior Clinical Trial

— ART  

Official title:

Age-Related Effects of THC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04294966
• Other study ID #: IRB20-0112
• Status: Completed
• Phase: Early Phase 1
• Start date: March 10, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: November 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

There is limited knowledge on the effects of THC in adolescents vs adults. One recent report compared responses to vaporized cannabis in heavy adolescent vs adult cannabis users and found that the adolescents were less sensitive to the drug on most measures. However, their findings were complicated by several factors: i) the study used vaporized cannabis, which may have other constituents and does not offer full control of the dose, ii) the participants were heavy users, making it difficult to determine the influence of prior drug exposure, and iii) the participants were not drug-free at the time of testing. Prior exposure to THC can lead to tolerance, and adolescents and adults may differ in the rate at which they develop tolerance, consistent with changes in CB1R receptor function. Our study will compare adolescent (here, aged 18 to 20) and adult (here, aged 30 to 40) responses to THC in relatively light cannabis users who are drug-free at the time of testing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• THC
• Tolerance

Intervention

Drug:
• Dextrose
Administering dextrose to healthy volunteers for our placebo group
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	University of Chicago Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))