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

Sponsor

University of California, Los Angeles (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05865470

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

103

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Abuse, Drug Intoxication; Cannabinoids	Drug: Cannabis Drug: Dronabinol Drug: Smoked Placebo Drug: Oral Placebo	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

103 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Sex- and AGE-dependent Effects of Smoked and Oral Delta-9-THC

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2027

Anticipated Study Completion Date :

Aug 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Comparator: Placebo Smoked Cannabis (0 mg THC) Oral placebo (0 mg THC)	Drug: Smoked Placebo Placebo Cannabis Other Names: Placebo smoked cannabis (no THC) Drug: Oral Placebo Oral Placebo
Experimental: Experimental: Low strength cannabis Smoked Cannabis (10 mg THC) Oral placebo (0 mg THC)	Drug: Cannabis smoked cannabis Other Names: Smoked cannabis with THC Drug: Oral Placebo Oral Placebo
Experimental: Experimental: Higher strength cannabis Smoked Cannabis (20 mg THC) Oral placebo (0 mg THC)	Drug: Cannabis smoked cannabis Other Names: Smoked cannabis with THC Drug: Oral Placebo Oral Placebo
Experimental: Experimental: Low strength oral THC Smoked Cannabis (0 mg THC) Oral THC (10 mg THC)	Drug: Dronabinol Oral delta-9-THC Other Names: Delta-9-THC Drug: Smoked Placebo Placebo Cannabis Other Names: Placebo smoked cannabis (no THC)
Experimental: Experimental: Higher strength oral THC Smoked Cannabis (0 mg THC) Oral THC (20 mg THC)	Drug: Dronabinol Oral delta-9-THC Other Names: Delta-9-THC Drug: Smoked Placebo Placebo Cannabis Other Names: Placebo smoked cannabis (no THC)

Outcome Measures

Primary Outcome Measures

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).
Analgesia as measured using the Cold Pressor Test [6 hours]
Peak and average pain threshold and tolerance assessed using the Cold Pressor Test
Impairment [6 hours]
The primary outcome measure for performance will be the peak difference from baseline scores of the Global Impairment Score
Pharmacokinetics of THC and metabolites [6 hours]
Plasma levels of THC, 11-OH-THC, and THCCOOH

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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