NCT05865470

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P75+ for phase_1 pain

Timeline
42mo left

Started Apr 2025

Longer than P75 for phase_1 pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Apr 2025Oct 2029

First Submitted

Initial submission to the registry

May 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
2 years until next milestone

Study Start

First participant enrolled

April 30, 2025

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2029

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

3.5 years

First QC Date

May 9, 2023

Last Update Submit

January 5, 2026

Conditions

PainAbuse, DrugIntoxication; Cannabinoids

Keywords

PainCannabisDelta-9-THCAgeSex

Outcome Measures

Primary Outcomes (4)

  • Subject-rated drug effects

    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

    Peak and average pain threshold and tolerance assessed using the Cold Pressor Test

    6 hours

  • Impairment

    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

    Plasma levels of THC, 11-OH-THC, and THCCOOH

    6 hours

Study Arms (5)

Placebo Comparator: Placebo

PLACEBO COMPARATOR

Smoked Cannabis (0 mg THC) Oral placebo (0 mg THC)

Drug: Smoked PlaceboDrug: Oral Placebo

Experimental: Low strength cannabis

EXPERIMENTAL

Smoked Cannabis (10 mg THC) Oral placebo (0 mg THC)

Drug: CannabisDrug: Oral Placebo

Experimental: Higher strength cannabis

EXPERIMENTAL

Smoked Cannabis (20 mg THC) Oral placebo (0 mg THC)

Drug: CannabisDrug: Oral Placebo

Experimental: Low strength oral THC

EXPERIMENTAL

Smoked Cannabis (0 mg THC) Oral THC (10 mg THC)

Drug: DronabinolDrug: Smoked Placebo

Experimental: Higher strength oral THC

EXPERIMENTAL

Smoked Cannabis (0 mg THC) Oral THC (20 mg THC)

Drug: DronabinolDrug: Smoked Placebo

Interventions

Smoked PlaceboDRUG

Placebo Cannabis

Also known as: Placebo smoked cannabis (no THC)
Experimental: Higher strength oral THCExperimental: Low strength oral THCPlacebo Comparator: Placebo
Oral PlaceboDRUG

Oral Placebo

Experimental: Higher strength cannabisExperimental: Low strength cannabisPlacebo Comparator: Placebo
CannabisDRUG

smoked cannabis

Also known as: Smoked cannabis with THC
Experimental: Higher strength cannabisExperimental: Low strength cannabis
DronabinolDRUG

Oral delta-9-THC

Also known as: Delta-9-THC
Experimental: Higher strength oral THCExperimental: Low strength oral THC

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Currently enrolled in another research protocol
  • Not using a contraceptive method (hormonal or barrier methods)
  • Intolerance to lactose and sesame (ingredients in the oral THC preparation)
  • Insensitivity to the Cold Pressor Test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Center for Cannabis and Cannabinoids

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

PainSubstance-Related DisordersMarijuana AbuseCoitus

Interventions

nabiximolsDronabinol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsChemically-Induced DisordersMental DisordersSexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Ziva Cooper, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziva D Cooper, PhD

CONTACT

310-983-3417zcooper@mednet.ucla.edu

Vincent Acebo

CONTACT

310-983-3417vacebo@mednet.ucla.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor / Director

Study Record Dates

First Submitted

May 9, 2023

First Posted

May 18, 2023

Study Start

April 30, 2025

Primary Completion (Estimated)

October 15, 2028

Study Completion (Estimated)

October 15, 2029

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)