Abuse, Drug, Intoxication; Cannabinoids, Pain
Conditions
Keywords
Pain, Cannabis, Delta-9-THC, Age, Sex
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.
Interventions
DRUGCannabis
smoked cannabis
DRUGDronabinol
Oral delta-9-THC
DRUGSmoked Placebo
Placebo Cannabis
DRUGOral Placebo
Oral Placebo
Sponsors
National Institute on Drug Abuse (NIDA)
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactZiva D Cooper, PhD
Backup ContactVincent Acebo
Outcome results
None listed