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

Yale University

Status and phase: Enrolling; Phase 1

Conditions: Cannabis

Treatments: Drug: THC; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02781519

1505015940

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

THC

Active Comparator group

Description:

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

Treatment:

Drug: THC

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo