THC and CBD: A Controlled Human Study Probing a Harm Reduction Strategy

NCT06859710 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 24-530693306
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to assess the impact of CBD on the effects of THC.

Conditions

Abuse, Drug; Pain

Keywords

Cannabis; THC; CBD

Outcome Measures

Primary Outcomes (4)

• Subject-rated drug effects of abuse liability

  Subject ratings of "Good Drug Effect" as measured using a visual analog scale (1-100 mm)

  3 hours

• Analgesia as measured using the Cold Pressor Test

  Pain threshold assessed using the Cold Pressor Test (percent baseline)

  3 hours

• Behavioral task performance as assessed by the DRUID App Score

  Trough composite scores on the DRUID App

  3 hours

• Pharmacokinetics of THC

  Peak plasma levels of THC (ng/ml)

  3 hours

Study Arms (8)

Placebo

PLACEBO COMPARATOR

0 mg THC, 0 mg CBD

Drug: Placebo

THC

ACTIVE COMPARATOR

20 mg THC, 0 mg CBD

Drug: THC

CBD 20

ACTIVE COMPARATOR

0 mg THC, 20 mg CBD

Drug: CBD 20 mg

CBD 40

ACTIVE COMPARATOR

0 mg THC, 40 mg CBD

Drug: CBD 40 mg

CBD 80

ACTIVE COMPARATOR

0 mg THC, 80 mg CBD

Drug: CBD 80 mg

THC with CBD 20

ACTIVE COMPARATOR

20 mg THC, 20 mg CBD

Drug: THC; Drug: CBD 20 mg

THC with CBD 40

ACTIVE COMPARATOR

20 mg THC, 40 mg CBD

Drug: THC; Drug: CBD 40 mg

THC with CBD 80

ACTIVE COMPARATOR

20 mg THC, 80 mg CBD

Drug: THC; Drug: CBD 80 mg

Interventions

Placebo DRUG

Vaporized Placebo

Also known as: Cannabis

Placebo

THC DRUG

Vaporized THC (20 mg)

Also known as: Cannabis

THC; THC with CBD 20; THC with CBD 40; THC with CBD 80

CBD 20 mg DRUG

Vaporized CBD (20 mg)

Also known as: Cannabis

CBD 20; THC with CBD 20

CBD 40 mg DRUG

Vaporized CBD (40 mg)

Also known as: Cannabis

CBD 40; THC with CBD 40

CBD 80 mg DRUG

Vaporized CBD (80 mg)

Also known as: Cannabis

CBD 80; THC with CBD 80

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or non-pregnant and non-lactating females aged 21-55 years
• Report cannabis use 1-7 days per week over the month prior to screening
• Not currently seeking treatment for their cannabis use
• History of inhaled cannabis use
• Have a Body Mass Index from 18.5 - 34 kg/m2
• Able to perform all study procedures
• Must be using a contraceptive (hormonal or barrier methods)

You may not qualify if:

• Meeting DSM-V criteria for severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine, mild or moderate CUD
• Evidence of severe psychiatric illness (e.g. mood or anxiety disorder with functional impairment or suicide risk, schizophrenia) 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.
• Report using other illicit drugs in the prior 4 weeks
• Current pain
• Pregnancy
• Currently enrolled in another research protocol
• Not using a contraceptive method (hormonal or barrier methods)
• Insensitivity to the cold water stimulus of the Cold Pressor Test
• Any disorders that might make cannabis administration hazardous as determined by evaluation physician after review of all medical assessments along with medical history.
• Not able to speak and read English

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Cannabis and Cannabinoids

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders; Pain; Marijuana Abuse

Interventions

nabiximols; Dronabinol

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Ziva Cooper, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziva Cooper, PhD

CONTACT

310-206-9942; zcooper@mednet.ucla.edu

Vincent Acebo

CONTACT

310-983-3417; vacebo@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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 5, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)