Age-dependent Effects of Smoked and Oral Delta-9-THC (SAGE)
January 5, 2026 updated by: Ziva D. Cooper, PhD, University of California, Los Angeles
Sex- and AGE-dependent Effects of Smoked and Oral Delta-9-THC
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
103
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vincent Acebo
- Phone Number: 310-983-3417
- Email: vacebo@mednet.ucla.edu
Study Contact Backup
- Name: Ziva D Cooper, PhD
- Phone Number: 310-983-3417
- Email: zcooper@mednet.ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Recruiting
- UCLA Center for Cannabis and Cannabinoids
-
Contact:
- Ziva D Cooper, PhD
- Phone Number: (310) 794 -1497
- Email: cannabislab@mednet.ucla.edu
-
Contact:
- Vince Acebo
- Email: vacebo@mednet.ucla.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo Comparator: Placebo
Smoked Cannabis (0 mg THC) Oral placebo (0 mg THC)
|
Placebo Cannabis
Other Names:
Oral Placebo
|
|
Experimental: Experimental: Low strength cannabis
Smoked Cannabis (10 mg THC) Oral placebo (0 mg THC)
|
Oral Placebo
smoked cannabis
Other Names:
|
|
Experimental: Experimental: Higher strength cannabis
Smoked Cannabis (20 mg THC) Oral placebo (0 mg THC)
|
Oral Placebo
smoked cannabis
Other Names:
|
|
Experimental: Experimental: Low strength oral THC
Smoked Cannabis (0 mg THC) Oral THC (10 mg THC)
|
Placebo Cannabis
Other Names:
Oral delta-9-THC
Other Names:
|
|
Experimental: Experimental: Higher strength oral THC
Smoked Cannabis (0 mg THC) Oral THC (20 mg THC)
|
Placebo Cannabis
Other Names:
Oral delta-9-THC
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subject-rated drug effects
Time Frame: 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).
|
6 hours
|
|
Analgesia as measured using the Cold Pressor Test
Time Frame: 6 hours
|
Peak and average pain threshold and tolerance assessed using the Cold Pressor Test
|
6 hours
|
|
Impairment
Time Frame: 6 hours
|
The primary outcome measure for performance will be the peak difference from baseline scores of the Global Impairment Score
|
6 hours
|
|
Pharmacokinetics of THC and metabolites
Time Frame: 6 hours
|
Plasma levels of THC, 11-OH-THC, and THCCOOH
|
6 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ziva Cooper, PhD, University of California, Los Angeles
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2025
Primary Completion (Estimated)
October 15, 2028
Study Completion (Estimated)
October 15, 2029
Study Registration Dates
First Submitted
May 9, 2023
First Submitted That Met QC Criteria
May 9, 2023
First Posted (Actual)
May 18, 2023
Study Record Updates
Last Update Posted (Actual)
January 7, 2026
Last Update Submitted That Met QC Criteria
January 5, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-001292
- R01DA057252 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.