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

NCT ID: NCT06859710

Last Updated: 2025-12-17

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

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2028-09-01

Brief Summary

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

Detailed Description

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Some evidence indicates that cannabidiol (CBD), a non-intoxicating cannabis component, might mitigate certain effects of THC. This study will examine possible roles for CBD in modulating THC's adverse and analgesic effects.

Conditions

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Abuse, Drug Pain

Study Design

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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

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Placebo

0 mg THC, 0 mg CBD

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vaporized Placebo

THC

20 mg THC, 0 mg CBD

Group Type ACTIVE_COMPARATOR

THC

Intervention Type DRUG

Vaporized THC (20 mg)

CBD 20

0 mg THC, 20 mg CBD

Group Type ACTIVE_COMPARATOR

CBD 20 mg

Intervention Type DRUG

Vaporized CBD (20 mg)

CBD 40

0 mg THC, 40 mg CBD

Group Type ACTIVE_COMPARATOR

CBD 40 mg

Intervention Type DRUG

Vaporized CBD (40 mg)

CBD 80

0 mg THC, 80 mg CBD

Group Type ACTIVE_COMPARATOR

CBD 80 mg

Intervention Type DRUG

Vaporized CBD (80 mg)

THC with CBD 20

20 mg THC, 20 mg CBD

Group Type ACTIVE_COMPARATOR

THC

Intervention Type DRUG

Vaporized THC (20 mg)

CBD 20 mg

Intervention Type DRUG

Vaporized CBD (20 mg)

THC with CBD 40

20 mg THC, 40 mg CBD

Group Type ACTIVE_COMPARATOR

THC

Intervention Type DRUG

Vaporized THC (20 mg)

CBD 40 mg

Intervention Type DRUG

Vaporized CBD (40 mg)

THC with CBD 80

20 mg THC, 80 mg CBD

Group Type ACTIVE_COMPARATOR

THC

Intervention Type DRUG

Vaporized THC (20 mg)

CBD 80 mg

Intervention Type DRUG

Vaporized CBD (80 mg)

Interventions

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Placebo

Vaporized Placebo

Intervention Type DRUG

THC

Vaporized THC (20 mg)

Intervention Type DRUG

CBD 20 mg

Vaporized CBD (20 mg)

Intervention Type DRUG

CBD 40 mg

Vaporized CBD (40 mg)

Intervention Type DRUG

CBD 80 mg

Vaporized CBD (80 mg)

Intervention Type DRUG

Other Intervention Names

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Cannabis Cannabis Cannabis Cannabis Cannabis

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Ziva D. Cooper, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ziva Cooper, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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UCLA Center for Cannabis and Cannabinoids

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ziva Cooper, PhD

Role: CONTACT

310-206-9942

Vincent Acebo

Role: CONTACT

310-983-3417

Facility Contacts

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Ziva D Cooper, PhD

Role: primary

(310) 794 -1497

Vince Acebo

Role: backup

Other Identifiers

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93306

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

24-5306

Identifier Type: -

Identifier Source: org_study_id