Clinical trial NCT05865470: Age-dependent Effects of Smoked and Oral Delta-9-THC
Official title: Sex- and AGE-dependent Effects of Smoked and Oral Delta-9-THC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pain
Abuse, Drug
Intoxication; Cannabinoids
Keywords: Pain
Cannabis
Delta-9-THC
Age
Sex
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-05-18
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subject-rated drug effects
timeFrame: 6 hours
measure: Analgesia as measured using the Cold Pressor Test
timeFrame: 6 hours
measure: Impairment
timeFrame: 6 hours
measure: Pharmacokinetics of THC and metabolites
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Center for Cannabis and Cannabinoids
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Ziva Cooper, PhD
role: PRINCIPAL_INVESTIGATOR
References: