The Effects of Cannabis on Male Reproductive Functions
- Conditions
- Male Reproductive Problem
- Interventions
- Registration Number
- NCT06755346
- Lead Sponsor
- Kanako Hayashi
- Brief Summary
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.
- Detailed Description
The Volcano Vaporizer will be used to expose cannabis or placebo plants.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 100
- Regular cannabis users (21~64 years-old men) who have used cannabis at least once a week for at least once a year or who have never used cannabis.
- Willingness to abstain from using cannabis on the day of the testing session (minimum 5 hours abstinence).
- Women
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cannabis users: placebo Cannabis (0%/ THC / 0% CBD) Cannabis users (n=20) will be assigned to a placebo group. Cannabis users: 20mg THC in cannabis plant Cannabis plant (THC 20mg) Cannabis users (n=20) will be assigned to a 20mg THC in cannabis group. Cannabis users: 40mg THC in cannabis plant Cannabis plant (THC 40mg) Cannabis users (n=20) will be assigned to a 40mg THC group.
- Primary Outcome Measures
Name Time Method Number of participants with treatment-related sperm parameters 30 minutes Sperm counts and motility, as well as DNA fragmentation, will be examined after vaping or no vaping.
Number of participants with treatment-related sperm epimutation 30 minutes Differentially methylated regions in sperm will be analyzed to examine the effects of cannabis exposure.
Number of participants with treatment-related plasma testosterone and THC/THC metabolites 4 hours Plasma testosterone and THC/THC metabolites will be analyzed to examine the effects of cannabis exposure.
- Secondary Outcome Measures
Name Time Method Number of participants with treatment-related stress reactivity and food intake 4 hours 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.
Trial Locations
- Locations (1)
Washington State University
🇺🇸Pullman, Washington, United States