Cannabis for Male Reproductive Issues

Overseen By Carrie Cuttler, PhD

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Kanako Hayashi

Must not be taking: Corticosteroids, Blood thinners

Disqualifiers: Women, Psychiatric conditions, Heart disease, others

Compensation: Varies

Number of Visits: 2

Duration: 1 day

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants stop using corticosteroids and blood thinners. If you are taking these medications, you will need to stop before participating.

What data supports the effectiveness of the drug cannabis for male reproductive issues?

The research suggests that cannabis use is generally associated with lower sperm concentrations, which may negatively impact fertility. While there is some exploration of cannabis's effects on testicular function and sperm quality in animal studies, the evidence is mostly contradictory and indicates potential adverse effects rather than benefits for male reproductive health. ^{1 2 3 4 5}

Is cannabis safe for male reproductive health?

Research suggests that cannabis use may negatively affect male reproductive health by lowering sperm counts and affecting sperm quality, which could impact fertility. Studies in animals also show that cannabis can impair sperm production and function. ^{1 2 3 6 7}

How does the drug cannabis differ from other treatments for male reproductive issues?

Cannabis is unique because it interacts with the endocannabinoid system, which plays a role in regulating male reproductive functions. Unlike other treatments, cannabis may have both negative and potential modulatory effects on sperm quality and testicular function, but its impact is still not well understood and can vary. ^{1 2 4 8 9}

What is the purpose of this trial?

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.

Research Team

Kanako Hayashi, PhD

Principal Investigator

Washington State University

Eligibility Criteria

This trial is for men with substance use disorder and reproductive issues. Participants must be cannabis users or non-users willing to provide blood and semen samples, as well as complete surveys on their cannabis use and sexual health.

Inclusion Criteria

I am a man aged 21-64 who uses cannabis weekly or have never used it.

Willingness to abstain from using cannabis on the day of the testing session (minimum 5 hours abstinence)

Exclusion Criteria

Family history of psychosis

I am a woman.

BMI over 34

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are exposed to cannabis or placebo via the Volcano Vaporizer, with assessments of reproductive parameters

1 day

1 visit (in-person)

Acute Monitoring

Participants undergo acute stress testing and monitoring of plasma cortisol and food intake

4 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cannabis

Trial Overview The study tests the effects of different doses of THC in cannabis (0mg, 20mg, 40mg) on male reproductive functions like sperm count and testosterone levels. It's a double-blind trial where participants won't know if they're getting THC or a placebo.

Participant Groups

Group I: non-cannabis users Active Control 1 Intervention

Non-cannabis users (n=20) will be assigned to a non-vaping group.

Group II: Cannabis users: non-vaping Active Control 1 Intervention

Cannabis users (n=20) will be assigned to a non-vaping group.

Group III: Cannabis users: 20mg THC in cannabis plant Active Control 1 Intervention

Cannabis users (n=20) will be assigned to a 20mg THC in cannabis group.

Group IV: Cannabis users: 40mg THC in cannabis plant Active Control 1 Intervention

Cannabis users (n=20) will be assigned to a 40mg THC group.

Group V: Cannabis users: placebo Placebo Group 1 Intervention

Cannabis users (n=20) will be assigned to a placebo group.

Who Is Running the Clinical Trial?

Kanako Hayashi

Lead Sponsor

Trials

1

Recruited

100+

Washington State University

Collaborator

Trials

114

Recruited

58,800+

References

1. England pubmed.ncbi.nlm.nih.gov

Experimental validation and molecular docking to explore the active components of cannabis in testicular function and sperm quality modulations in rats. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse Effects of Cannabis on Male Reproduction. [2020]

3. Canada pubmed.ncbi.nlm.nih.gov

The impact of cannabis use on male sexual function: A 10-year, single-center experience. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Cannabis and Paternal Epigenetic Inheritance. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The association between cannabis use and testicular function in men: A systematic review and meta-analysis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Long-term use of HU210 adversely affects spermatogenesis in rats by modulating the endocannabinoid system. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Quantitative evaluation of spermatogenesis in mice following chronic exposure to cannabinoids. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Cannabis and Male Fertility: A Systematic Review. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Marijuana, phytocannabinoids, the endocannabinoid system, and male fertility. [2022]