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| Name | Class |
|---|---|
| Washington State University | OTHER |
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The purpose of this study is to understand the direct effects of cannabis on male reproductive functions. The investigators plan to conduct a double-blind, placebo-controlled clinical trial to examine both the chronic and acute effects of cannabis use on male reproductive functions. Specifically, the investigators will examine the dose-dependent effects of acute cannabis use on male reproductive parameters, including sperm counts, motility, morphology, and testosterone levels, as well as sperm epimutations.
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.
The Volcano Vaporizer will be used to expose cannabis or placebo plants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabis users: non-vaping | No Intervention | Cannabis users (n=20) will be assigned to a non-vaping group. | |
| Cannabis users: placebo | Placebo Comparator | Cannabis users (n=20) will be assigned to a placebo group. |
|
| Cannabis users: 20mg THC in cannabis plant | Active Comparator | Cannabis users (n=20) will be assigned to a 20mg THC in cannabis group. |
|
| Cannabis users: 40mg THC in cannabis plant | Active Comparator | Cannabis users (n=20) will be assigned to a 40mg THC group. |
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| non-cannabis users | No Intervention | Non-cannabis users (n=20) will be assigned to a non-vaping group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabis plant (THC 20mg) | Drug | Cannabis flower - very High THC (>10%) / Low CBD (<1%) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related sperm parameters | Sperm counts and motility, as well as DNA fragmentation, will be examined after vaping or no vaping. | 30 minutes |
| Number of participants with treatment-related sperm epimutation | Differentially methylated regions in sperm will be analyzed to examine the effects of cannabis exposure. | 30 minutes |
| Number of participants with treatment-related plasma testosterone and THC/THC metabolites | Plasma testosterone and THC/THC metabolites will be analyzed to examine the effects of cannabis exposure. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related stress reactivity and food intake | After the vaping session and semen collection, participants will complete the Acute Stress Test. Plsama cortisol will be analyzed before and after the Acute Stress Test. During sobering (~4 hours), snacks (e.g., fruit snacks, granola bars, chips, chocolate, soda, juice, and water) will be available for participants. Investigators will monitor participants via the window in the adjacent room to monitor and record the snacks/beverages participants choose to consume. |
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Inclusion Criteria:
Exclusion Criteria:
Only biological men are eligible
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kanako Hayashi, PhD | Contact | 800-555-5555 | k.hayashi@wsu.edu | |
| Carrie Cuttler, PhD | Contact | 800-555-5555 | carrie.cuttler@wsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kanako Hayashi, PhD | Washington State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington State University | Pullman | Washington | 99164 | United States |
This is our first small study to obtain preliminary results. We plan to propose to investigate the effects of acute and chronic cannabis exposure on male reproductive functions in humans, which include single or multiple cannabis vaping exposures and multiple semen collections in the same individual with a larger sample of participants. The data from the large study will be shared.
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| C587251 | nabiximols |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Cannabis (0%/ THC / 0% CBD) | Drug | THC (0%) / CBD (0%) - Placebo marijuana |
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| Cannabis plant (THC 40mg) | Drug | Cannabis flower - very High THC (>10%) / Low CBD (<1%) |
|
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| 4 hours |