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Age-Related Effects of THC (ART)

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The University of Chicago

Status and phase

Completed
Early Phase 1

Conditions

THC
Tolerance
Adolescent Behavior

Treatments

Drug: Dextrose
Drug: Dronabinol

Study type

Interventional

Funder types

Other

Identifiers

NCT04294966
IRB20-0112

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

24 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Drug: Dextrose
7.5 mg THC
Active Comparator group
Treatment:
Drug: Dronabinol
Drug: Dronabinol
15 mg THC
Active Comparator group
Treatment:
Drug: Dronabinol
Drug: Dronabinol

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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