The Effects of Cannabis on Male Reproductive Functions

Kanako Hayashi

Status and phase: Not yet enrolling; Phase 1

Conditions: Male Reproductive Problem

Treatments: Drug: Cannabis plant (THC 20mg); Drug: Cannabis plant (THC 40mg); Drug: Cannabis (0%/ THC / 0% CBD)

Study type: Interventional

Funder types: Other

Identifiers

NCT06755346

WSU_IRB#20730

Details and patient eligibility

About

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.

Full description

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

Enrollment: 100 estimated patients

Sex: Male

Ages: 21 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 5 patient groups, including a placebo group

Cannabis users: non-vaping

No Intervention group

Description:

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

Cannabis users: placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Cannabis (0%/ THC / 0% CBD)

Cannabis users: 20mg THC in cannabis plant

Active Comparator group

Description:

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

Treatment:

Drug: Cannabis plant (THC 20mg)

Cannabis users: 40mg THC in cannabis plant

Active Comparator group

Description:

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

Treatment:

Drug: Cannabis plant (THC 40mg)

non-cannabis users

No Intervention group

Description:

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