The Effects of Cannabis on Male Reproductive Functions

January 1, 2025 updated by: Kanako Hayashi

The Acute and Chronic Effects of Cannabis on Reproductive Functions in Men

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The Volcano Vaporizer will be used to expose cannabis or placebo plants.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Pullman, Washington, United States, 99164
        • Washington State University
        • Contact:
          • Carrie Cuttler, PhD
        • Contact:
        • Contact:
        • Contact:
          • Kanako Hayashi, PhD
        • Contact:
          • Ryan McLaughlin, PhD
        • Contact:
          • James A. MacLean, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Cannabis users: non-vaping
Cannabis users (n=20) will be assigned to a non-vaping group.
Placebo Comparator: Cannabis users: placebo
Cannabis users (n=20) will be assigned to a placebo group.
Drug: Cannabis (0%/ THC / 0% CBD)
THC (0%) / CBD (0%) - Placebo marijuana
Active Comparator: Cannabis users: 20mg THC in cannabis plant
Cannabis users (n=20) will be assigned to a 20mg THC in cannabis group.
Drug: Cannabis plant (THC 20mg)
Cannabis flower - very High THC (>10%) / Low CBD (<1%)
Other Names:
  • marijuana
Active Comparator: Cannabis users: 40mg THC in cannabis plant
Cannabis users (n=20) will be assigned to a 40mg THC group.
Drug: Cannabis plant (THC 40mg)
Cannabis flower - very High THC (>10%) / Low CBD (<1%)
Other Names:
  • marijuana
No Intervention: non-cannabis users
Non-cannabis users (n=20) will be assigned to a non-vaping group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related plasma testosterone and THC/THC metabolites
Time Frame: 4 hours
Plasma testosterone and THC/THC metabolites will be analyzed to examine the effects of cannabis exposure.
4 hours
Number of participants with treatment-related sperm parameters
Time Frame: 30 minutes
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
Time Frame: 30 minutes
Differentially methylated regions in sperm will be analyzed to examine the effects of cannabis exposure.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related stress reactivity and food intake
Time Frame: 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.
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanako Hayashi

Collaborators

Washington State University

Investigators

  • Principal Investigator: Kanako Hayashi, PhD, Washington State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

December 23, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 1, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WSU_IRB#20730

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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