Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone: Sub-Study I (THC-PREG-I)

Yale University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Active Dronabinol; Drug: Placebo Dronabinol; Drug: Placebo Pregnenolone; Drug: Active Pregnenolone

Study type: Interventional

Funder types: Other

Identifiers

NCT02811939

1501015242.A

Details and patient eligibility

About

The overall purpose of this study is to examine the effect of Pregnenolone (PREG) on the acute psychosis-like and cognitive effects of Delta-9-Tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with PREG, and then assessing their responses to Dronabinol (THC).

Enrollment: 13 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Exposed to cannabis at least once in lifetime

Exclusion criteria

• Cannabis naïve
• Individuals with a documented reaction/allergy to Pregnenolone
• Individuals with a documented reaction/allergy to Sesame oil

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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13 participants in 4 patient groups, including a placebo group

Active THC and Placebo Pregnenolone

Experimental group

Treatment:

Drug: Placebo Pregnenolone

Drug: Active Dronabinol

Active THC and Active Pregnenolone

Experimental group

Treatment:

Drug: Active Pregnenolone

Drug: Active Dronabinol

Placebo THC and Active Pregnenolone

Experimental group

Treatment:

Drug: Active Pregnenolone

Drug: Placebo Dronabinol

Placebo THC and Placebo Pregnenolone

Placebo Comparator group

Treatment:

Drug: Placebo Pregnenolone

Drug: Placebo Dronabinol