Study Results
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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RECRUITING
PHASE1
103 participants
INTERVENTIONAL
2025-04-30
2029-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Placebo Comparator: Placebo
Smoked Cannabis (0 mg THC) Oral placebo (0 mg THC)
Smoked Placebo
Placebo Cannabis
Oral Placebo
Oral Placebo
Experimental: Low strength cannabis
Smoked Cannabis (10 mg THC) Oral placebo (0 mg THC)
Cannabis
smoked cannabis
Oral Placebo
Oral Placebo
Experimental: Higher strength cannabis
Smoked Cannabis (20 mg THC) Oral placebo (0 mg THC)
Cannabis
smoked cannabis
Oral Placebo
Oral Placebo
Experimental: Low strength oral THC
Smoked Cannabis (0 mg THC) Oral THC (10 mg THC)
Dronabinol
Oral delta-9-THC
Smoked Placebo
Placebo Cannabis
Experimental: Higher strength oral THC
Smoked Cannabis (0 mg THC) Oral THC (20 mg THC)
Dronabinol
Oral delta-9-THC
Smoked Placebo
Placebo Cannabis
Interventions
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Cannabis
smoked cannabis
Dronabinol
Oral delta-9-THC
Smoked Placebo
Placebo Cannabis
Oral Placebo
Oral Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Report weekly-monthly use of cannabis (with primary mode of use via inhalation) over the past 6 months prior to screening
* Not currently seeking treatment for their cannabis use
* No reported clinically significant adverse effects with cannabis use
* Have a Body Mass Index from 18.5 - 34kg/m2
* Able to perform all study procedures
* FEMALES: Currently practicing an effective form of birth control if pre-menopausal
Exclusion Criteria
* Report using other illicit drugs in the prior 4 weeks
* Evidence of severe psychiatric illness (e.g. mood disorder with functional impairment or suicide risk, schizophrenia) or medical condition (i.e., hypertension) 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.
* Current predominant licit use of medical cannabis
* Current use of prescription or regular use of over the counter medications (with the exception of hormonal contraceptives and hormone replacement therapy). Current use of herbal supplements that may affect study outcomes or interact with study drug (i.e., St Johns wort, kava, L-tryptophan, melatonin)
* If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process are not within the normal range and / or reveal any significant illness (e.g., hypertension) as judged by the study physician and to put the participant at greater risk of experiencing adverse events due to completion of study procedures
* Current pain
* Pregnancy is exclusionary due to the possible effects of the study medication on fetal development
* History of an allergic reaction or adverse reaction to cannabis is exclusionary.
* Currently enrolled in another research protocol
* Not using a contraceptive method (hormonal or barrier methods)
* The evaluating physician reviews all medical assessments along with medical history. Any disorders that might make cannabis administration hazardous are exclusionary.
* Intolerance to lactose and sesame (ingredients in the oral THC preparation)
* Insensitivity to the Cold Pressor Test
18 Years
65 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of California, Los Angeles
OTHER
Responsible Party
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Ziva D. Cooper, PhD
Professor / Director
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-001292
Identifier Type: -
Identifier Source: org_study_id
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