The Effects of Cannabis on Male Reproductive Functions

NCT ID: NCT06755346

Last Updated: 2025-01-03

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2027-03-30

Brief Summary

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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.

Detailed Description

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

Conditions

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Male Reproductive Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cannabis users: non-vaping

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Cannabis users: placebo

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

Group Type PLACEBO_COMPARATOR

Cannabis (0%/ THC / 0% CBD)

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Cannabis plant (THC 20mg)

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Cannabis plant (THC 40mg)

Intervention Type DRUG

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cannabis plant (THC 20mg)

Cannabis flower - very High THC (\>10%) / Low CBD (\<1%)

Intervention Type DRUG

Cannabis (0%/ THC / 0% CBD)

THC (0%) / CBD (0%) - Placebo marijuana

Intervention Type DRUG

Cannabis plant (THC 40mg)

Cannabis flower - very High THC (\>10%) / Low CBD (\<1%)

Intervention Type DRUG

Other Intervention Names

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marijuana marijuana

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Washington State University

OTHER

Sponsor Role collaborator

Kanako Hayashi

OTHER

Sponsor Role lead

Responsible Party

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Kanako Hayashi

Professor

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Countries

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United States

Central Contacts

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Kanako Hayashi, PhD

Role: CONTACT

800-555-5555

Carrie Cuttler, PhD

Role: CONTACT

800-555-5555

Facility Contacts

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Kanako Hayashi, PhD

Role: primary

800-555-5555

Carrie Cuttler, PhD

Role: backup

800-555-5555

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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