Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans

NCT ID: NCT02781519

Last Updated: 2025-06-10

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cannabis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

THC

Active THC (0.015mg/kg) administered intravenously over 10 minutes.

Group Type ACTIVE_COMPARATOR

THC

Intervention Type DRUG

Active THC (0.015mg/kg) administered over 10 minutes

Placebo

Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 10 minutes.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Control: small amount of alcohol (quarter teaspoon), with no THC over 10 minutes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

THC

Active THC (0.015mg/kg) administered over 10 minutes

Intervention Type DRUG

Placebo

Control: small amount of alcohol (quarter teaspoon), with no THC over 10 minutes

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Delta-9-Tetrahydrocannabinol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* at least one lifetime exposure to cannabis
* good physical and mental health

Exclusion Criteria

* cannabis naive individuals
* major current or recent stressors
* taking estrogen supplements or oral contraceptive pills (for women)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohini Ranganathan

Assistant Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine

West Haven, Connecticut, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Christina Luddy, BS

Role: CONTACT

203-932-5711 ext. 4549

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Christina Luddy, BS

Role: primary

203-932-5711 ext. 4549

References

Explore related publications, articles, or registry entries linked to this study.

Mohammad Aghaei A, Urban Spillane L, Pittman B, Flynn LT, De Aquino JP, Bassir Nia A, Ranganathan M. Sex differences in the acute effects of oral THC: a randomized, placebo-controlled, crossover human laboratory study. Psychopharmacology (Berl). 2024 Oct;241(10):2145-2155. doi: 10.1007/s00213-024-06625-6. Epub 2024 Jun 4.

Reference Type DERIVED
PMID: 38832949 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1505015940

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cannabinoids, Learning, and Memory
NCT02407808 ACTIVE_NOT_RECRUITING PHASE1
Pharmacogenetics of Cannabinoid Response
NCT00678730 COMPLETED EARLY_PHASE1
N-acetylcysteine Effects on Tetrahydrocannabinol
NCT02335060 TERMINATED EARLY_PHASE1
THC Memory & Reward Learning Pilot
NCT05116527 ACTIVE_NOT_RECRUITING PHASE1/PHASE2
Effects of Dronabinol (Oral THC) on Cannabis Use
NCT01394185 COMPLETED PHASE1/PHASE2
Age-Related Effects of THC
NCT04294966 COMPLETED EARLY_PHASE1