THC and CBD: A Controlled Human Study Probing a Harm Reduction Strategy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, THC, CBD 20 mg, CBD 40 mg.
- Who it may be relevant to
- Registry conditions: Abuse, Drug, Pain. Basic parameters: 21 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Interactions Between Delta-9-THC and CBD: A Controlled Human Drug-administration Study Probing a Harm Reduction Strategy
Overview
The purpose of this research is to assess the impact of CBD on the effects of THC.
Detailed 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.
Interventions
- Drug Placebo
Vaporized Placebo - Drug THC
Vaporized THC (20 mg) - Drug CBD 20 mg
Vaporized CBD (20 mg) - Drug CBD 40 mg
Vaporized CBD (40 mg) - Drug CBD 80 mg
Vaporized CBD (80 mg)
Primary outcome measures
- Subject-rated drug effects of abuse liability [Time frame: 3 hours]
- Analgesia as measured using the Cold Pressor Test [Time frame: 3 hours]
- Behavioral task performance as assessed by the DRUID App Score [Time frame: 3 hours]
- Pharmacokinetics of THC [Time frame: 3 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- UCLA Center for Cannabis and Cannabinoids — Los Angeles
Identifiers
NCT: NCT06859710 · 24-5306 · 93306