Abuse, Drug, Pain
Conditions
Keywords
Cannabis, THC, CBD
Brief summary
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
DRUGPlacebo
Vaporized Placebo
DRUGTHC
Vaporized THC (20 mg)
DRUGCBD 20 mg
Vaporized CBD (20 mg)
DRUGCBD 40 mg
Vaporized CBD (40 mg)
DRUGCBD 80 mg
Vaporized CBD (80 mg)
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject-rated drug effects of abuse liability | 3 hours | Subject ratings of Good Drug Effect as measured using a visual analog scale (1-100 mm) |
| Analgesia as measured using the Cold Pressor Test | 3 hours | Pain threshold assessed using the Cold Pressor Test (percent baseline) |
| Behavioral task performance as assessed by the DRUID App Score | 3 hours | Trough composite scores on the DRUID App |
| Pharmacokinetics of THC | 3 hours | Peak plasma levels of THC (ng/ml) |
Countries
United States
Contacts
Primary ContactZiva Cooper, PhD
Backup ContactVincent Acebo
Outcome results
None listed