Evaluation of Smoked THC and CBD in Men and Women

NCT ID: NCT05037487

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2026-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of inhaled cannabis with varying amounts of delta-9-tetrahydrocannabinol (THC), and cannabidiol (CBD) and to evaluate detection of recently smoked THC in oral fluid.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This double-blind placebo controlled, within-subject study study will assess testing devices that can measure biochemical markers in oral fluid and neurocognitive-performance markers of recent cannabis use. Other pharmacodynamic effects of inhaled cannabis with CBD and THC will be determined and the pharmacokinetics of THC, CBD, and respective metabolites will be assessed in whole blood.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Drug Abuse Intoxication by Drug Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Smoked placebo cannabis

Group Type PLACEBO_COMPARATOR

Placebo Cannabis

Intervention Type DRUG

Smoked placebo cannabis

20 mg CBD

Smoked cannabis with CBD

Group Type EXPERIMENTAL

20 mg CBD Cannabis

Intervention Type DRUG

Smoked cannabis with CBD

20 mg CBD + 20 mg THC

Smoked cannabis with CBD and THC

Group Type EXPERIMENTAL

20 mg CBD + 20 mg THC Cannabis

Intervention Type DRUG

Smoked cannabis with CBD and THC

20 mg THC

Smoked cannabis with THC

Group Type EXPERIMENTAL

20 mg THC Cannabis

Intervention Type DRUG

Smoked cannabis with THC

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo Cannabis

Smoked placebo cannabis

Intervention Type DRUG

20 mg CBD Cannabis

Smoked cannabis with CBD

Intervention Type DRUG

20 mg CBD + 20 mg THC Cannabis

Smoked cannabis with CBD and THC

Intervention Type DRUG

20 mg THC Cannabis

Smoked cannabis with THC

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or non-pregnant and non-lactating females aged 21-55 years
* Report weekly-monthly use of cannabis (≤1 day per week) over the past month prior to screening,
* Not currently seeking treatment for their cannabis use
* Have a Body Mass Index from 18.5 - 34kg/m2.
* Able to perform all study procedures
* Must be using a contraceptive (hormonal or barrier methods)

Exclusion Criteria

* Meeting DSM-V criteria for moderate to severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine
* Any other Axis I disorder
* Report using other illicit drugs in the prior 4 weeks, other than cannabis.
* Current use of any medications that may affect study outcomes
* 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.
* 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.
* History of respiratory illness or current respiratory illness
* 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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ziva D. Cooper, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ziva Cooper, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ziva Cooper, PhD

Role: CONTACT

310-206-9942

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ziva Cooper, PhD

Role: primary

310-206-9942

Vincent Acebo, PhD

Role: backup

310-983-3417

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

21-001137

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Processing and Effects of Cannabis
NCT00225407 UNKNOWN PHASE1
Acute Effects of Cannabis on Cognition and Affect
NCT07296874 NOT_YET_RECRUITING PHASE2
Acute Effects of Cannabigerol
NCT05257044 COMPLETED PHASE1
Sex Differences in Neural Response to Cannabidiol
NCT04777643 COMPLETED EARLY_PHASE1
Effect of Cannabidiol (CBD) on Vision and Driving
NCT06322303 ACTIVE_NOT_RECRUITING EARLY_PHASE1
Cannabidiol and Autonomic Function at Rest
NCT04731779 COMPLETED EARLY_PHASE1