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

Yale University

Status and phase: Enrolling; Phase 1

Conditions: Cannabis

Treatments: Drug: Inhaled THC; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04704271

1505015940.B

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.

Full description

To characterize the acute effects of vaporized THC 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 naïve individuals
• Major current or recent stressors

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

Delta-9-Tetrahydrocannabinol (THC)

Active Comparator group

Description:

4 mg vaporized THC will be administered.

Treatment:

Drug: Inhaled THC

Placebo

Placebo Comparator group

Description:

Inhaled placebo (no active cannabinoids)

Treatment:

Drug: Placebo