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Early Phase 1 N=24 Randomized Quadruple-blind Basic Science

Age-Related Effects of THC

Tolerance · Adolescent Behavior · THC

Bottom Line

View on ClinicalTrials.gov: NCT04294966 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Change From Baseline in Profile of Mood States (POMS) — 5.75; 12.46; 18.55; 4.08 units on a scale

Study Design & Population

Study type
Interventional
Phase
Early Phase 1
Interventions
Dextrose (Drug); Dronabinol (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of Chicago
Primary completion
May 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Profile of Mood States (POMS)		 5.75; 12.46; 18.55; 4.08; 5.05; 6.25 —

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04294966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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