Recruiting
Phase 1

THC

Sponsor:

UCLA

Code:

NCT05865470

Conditions

Pain

Abuse, Drug

Intoxication; Cannabinoids

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Cannabis

Dronabinol

Smoked Placebo

Oral Placebo

Study Details

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.

Conditions

Pain

Abuse, Drug

Intoxication; Cannabinoids

Study ID

NCT05865470

Start date

Apr 30, 2025

Status verified date

Jan, 2026

Completion date

Oct 15, 2029

Anticipated

Primary completion date

Oct 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

103 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo Comparator: Placebo

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

experimental: Experimental: Low strength cannabis

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

experimental: Experimental: Higher strength cannabis

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

experimental: Experimental: Low strength oral THC

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

experimental: Experimental: Higher strength oral THC

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

Interventions

Cannabis

smoked cannabis

Dronabinol

Oral delta-9-THC

Smoked Placebo

Placebo Cannabis

Oral Placebo

Oral Placebo

Primary outcome measure

  • Subject-rated drug effects [ Time Frame: 6 hours ]
  • Analgesia as measured using the Cold Pressor Test [ Time Frame: 6 hours ]
  • Impairment [ Time Frame: 6 hours ]
  • Pharmacokinetics of THC and metabolites [ Time Frame: 6 hours ]

Central Contacts and Locations

Central contacts

Ziva D Cooper, PhD

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

Vincent Acebo

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

Locations

UCLA Center for Cannabis and Cannabinoids

Recruiting

Los Angeles, California, United States, 90095

Contacts

Ziva D Cooper, PhD

(310) 794 -1497cannabislab@mednet.ucla.edu

Vince Acebo

vacebo@mednet.ucla.edu

More Information

Sponsor

University of California, Los Angeles

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

  • Pain
  • Cannabis
  • Delta-9-THC
  • Age
  • Sex

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-01-07.