THC and CBD: A Controlled Human Study Probing a Harm Reduction Strategy (THC-REDUX)

University of California, Los Angeles (UCLA)

Status and phase: Begins enrollment this month; Phase 1

Conditions: Abuse, Drug; Pain

Treatments: Drug: THC; Drug: CBD 20 mg; Drug: CBD 80 mg; Drug: CBD 40 mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06859710

93306 (Other Grant/Funding Number)

24-5306

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 8 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

0 mg THC, 0 mg CBD

Treatment:

Drug: Placebo

THC

Active Comparator group

Description:

20 mg THC, 0 mg CBD

Treatment:

Drug: THC

CBD 20

Active Comparator group

Description:

0 mg THC, 20 mg CBD

Treatment:

Drug: CBD 20 mg

CBD 40

Active Comparator group

Description:

0 mg THC, 40 mg CBD

Treatment:

Drug: CBD 40 mg

CBD 80

Active Comparator group

Description:

0 mg THC, 80 mg CBD

Treatment:

Drug: CBD 80 mg

THC with CBD 20

Active Comparator group

Description:

20 mg THC, 20 mg CBD

Treatment:

Drug: CBD 20 mg

Drug: THC

THC with CBD 40

Active Comparator group

Description:

20 mg THC, 40 mg CBD

Treatment:

Drug: CBD 40 mg

Drug: THC

THC with CBD 80

Active Comparator group

Description:

20 mg THC, 80 mg CBD

Treatment:

Drug: CBD 80 mg

Drug: THC