Age-dependent Effects of Smoked and Oral Delta-9-THC

Phase 1

Recruiting

• Conditions: Abuse, Drug; Intoxication; Cannabinoids; Pain
• Interventions: Drug: Smoked Placebo; Drug: Dronabinol; Drug: Cannabis; Drug: Oral Placebo

• Registration Number: NCT05865470
• Lead Sponsor: University of California, Los Angeles

Brief Summary

This study will assess the age-dependent effects of smoked and oral THC on abuse liability, intoxication, analgesia and impairment as a function of age.

Detailed Description

The overall objective of this placebo-controlled, outpatient study is to compare the dose-dependent effects of smoked and oral THC on analgesia and endpoints directly related to adverse consequences of use including abuse liability, intoxication, and impairment as a function of age and sex.

Study Timeline

• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-18
• Status Verified: 2025-04
• Study Start: 2025-04-30
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06
• Primary Completion: 2028-04-15
• Study Completion: 2029-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Male or non-pregnant female aged 18-65 years according to the below criteria: EMERGING ADULTS: 18-25 years of age (+/- one year) MIDDLE-AGED ADULTS: 35-45 years of age (+/- one year) LATE MIDDLE-AGED ADULTS: 55-65 years of age (+/- one year)
• Report weekly-monthly use of cannabis (with primary mode of use via inhalation) over the past 6 months prior to screening
• Not currently seeking treatment for their cannabis use
• No reported clinically significant adverse effects with cannabis use
• Have a Body Mass Index from 18.5 - 34kg/m2
• Able to perform all study procedures
• FEMALES: Currently practicing an effective form of birth control if pre-menopausal

Exclusion Criteria

• Meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria for any substance use disorder other than nicotine and mild cannabis use disorder
• Report using other illicit drugs in the prior 4 weeks
• Evidence of severe psychiatric illness (e.g. mood disorder with functional impairment or suicide risk, schizophrenia) or medical condition (i.e., hypertension) judged by the study physician (and PI to put the participant at greater risk of experiencing adverse events due to completion of study procedures, interfere with their ability to participate in the study, or their capacity to provide informed consent.
• Current predominant licit use of medical cannabis
• Current use of prescription or regular use of over the counter medications (with the exception of hormonal contraceptives and hormone replacement therapy). Current use of herbal supplements that may affect study outcomes or interact with study drug (i.e., St Johns wort, kava, L-tryptophan, melatonin)
• If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process are not within the normal range and / or reveal any significant illness (e.g., hypertension) as judged by the study physician and to put the participant at greater risk of experiencing adverse events due to completion of study procedures
• Current pain
• Pregnancy is exclusionary due to the possible effects of the study medication on fetal development
• History of an allergic reaction or adverse reaction to cannabis is exclusionary.
• Currently enrolled in another research protocol
• Not using a contraceptive method (hormonal or barrier methods)
• The evaluating physician reviews all medical assessments along with medical history. Any disorders that might make cannabis administration hazardous are exclusionary.
• Intolerance to lactose and sesame (ingredients in the oral THC preparation)
• Insensitivity to the Cold Pressor Test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Comparator: Placebo	Smoked Placebo	Smoked Cannabis (0 mg THC) Oral placebo (0 mg THC)
Experimental: Higher strength cannabis	Oral Placebo	Smoked Cannabis (20 mg THC) Oral placebo (0 mg THC)
Placebo Comparator: Placebo	Oral Placebo	Smoked Cannabis (0 mg THC) Oral placebo (0 mg THC)
Experimental: Low strength cannabis	Oral Placebo	Smoked Cannabis (10 mg THC) Oral placebo (0 mg THC)
Experimental: Low strength oral THC	Smoked Placebo	Smoked Cannabis (0 mg THC) Oral THC (10 mg THC)
Experimental: Low strength oral THC	Dronabinol	Smoked Cannabis (0 mg THC) Oral THC (10 mg THC)
Experimental: Higher strength oral THC	Dronabinol	Smoked Cannabis (0 mg THC) Oral THC (20 mg THC)
Experimental: Higher strength oral THC	Smoked Placebo	Smoked Cannabis (0 mg THC) Oral THC (20 mg THC)
Experimental: Low strength cannabis	Cannabis	Smoked Cannabis (10 mg THC) Oral placebo (0 mg THC)
Experimental: Higher strength cannabis	Cannabis	Smoked Cannabis (20 mg THC) Oral placebo (0 mg THC)

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of THC and metabolites	6 hours	Plasma levels of THC, 11-OH-THC, and THCCOOH
Subject-rated drug effects	6 hours	Average and peak subjective ratings of drug effects associated with abuse liability and intoxication as measured using visual analogue scales (VAS; 1-100mm).
Impairment	6 hours	The primary outcome measure for performance will be the peak difference from baseline scores of the Global Impairment Score
Analgesia as measured using the Cold Pressor Test	6 hours	Peak and average pain threshold and tolerance assessed using the Cold Pressor Test

Trial Locations

Locations (1)

UCLA Center for Cannabis and Cannabinoids; 🇺🇸 Los Angeles, California, United States