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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NOT_YET_RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2025-04-01
2027-03-30
Brief Summary
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Participants \[cannabis users will be randomly assigned to 1) non-vaping, 2) placebo (vaping without cannabis), and 2 doses of cannabis, 3) 20 and 4) 40mg of THC in cannabis flower obtained from the NIDA drug supply\], and 5) non-cannabis users (naïve control, no cannabis or placebo exposure).
Participants will provide surveys (cannabis use and sexual functioning and satisfaction etc.), peripheral blood, and semen.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Cannabis users: non-vaping
Cannabis users (n=20) will be assigned to a non-vaping group.
No interventions assigned to this group
Cannabis users: placebo
Cannabis users (n=20) will be assigned to a placebo group.
Cannabis (0%/ THC / 0% CBD)
THC (0%) / CBD (0%) - Placebo marijuana
Cannabis users: 20mg THC in cannabis plant
Cannabis users (n=20) will be assigned to a 20mg THC in cannabis group.
Cannabis plant (THC 20mg)
Cannabis flower - very High THC (\>10%) / Low CBD (\<1%)
Cannabis users: 40mg THC in cannabis plant
Cannabis users (n=20) will be assigned to a 40mg THC group.
Cannabis plant (THC 40mg)
Cannabis flower - very High THC (\>10%) / Low CBD (\<1%)
non-cannabis users
Non-cannabis users (n=20) will be assigned to a non-vaping group.
No interventions assigned to this group
Interventions
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Cannabis plant (THC 20mg)
Cannabis flower - very High THC (\>10%) / Low CBD (\<1%)
Cannabis (0%/ THC / 0% CBD)
THC (0%) / CBD (0%) - Placebo marijuana
Cannabis plant (THC 40mg)
Cannabis flower - very High THC (\>10%) / Low CBD (\<1%)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willingness to abstain from using cannabis on the day of the testing session (minimum 5 hours abstinence).
Exclusion Criteria
* Adult men, 65 or older, and men under the age of 21
* Serious psychiatric conditions (e.g. psychosis, bipolar I and panic disorder)
* Family history of psychosis
* Chronic medical conditions (e.g., heart disease, diabetes)
* History of adverse experiences with cannabis (e.g., anxiety and panic attacks)
* Use of other illicit drugs (not cannabis) in the past 2 months
* Heavy alcohol use (\>4 drinks, \>4 times/week)
* Smoking/nicotine use
* Infrequent cannabis use (less than once a week for only cannabis users)
* BMI over 34
* Current use of corticosteroids and blood thinners
21 Years
64 Years
MALE
Yes
Sponsors
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Washington State University
OTHER
Kanako Hayashi
OTHER
Responsible Party
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Kanako Hayashi
Professor
Principal Investigators
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Kanako Hayashi, PhD
Role: PRINCIPAL_INVESTIGATOR
Washington State University
Locations
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Washington State University
Pullman, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Kanako Hayashi, PhD
Role: backup
Carrie Cuttler, PhD
Role: backup
Ryan McLaughlin, PhD
Role: backup
James A. MacLean, PhD
Role: backup
Other Identifiers
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WSU_IRB#20730
Identifier Type: -
Identifier Source: org_study_id
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