Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone (THC-Preg)

Yale University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Active Pregnenolone; Drug: Active Delta-9-THC

Study type: Interventional

Funder types: Other

Identifiers

NCT02576912

1501015242

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 THC.

Enrollment: 38 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 naive
• Individuals with a documented reaction/allergy to Pregnenolone

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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38 participants in 4 patient groups, including a placebo group

Active Delta-9-THC and Placebo Pregnenolone

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Active Delta-9-THC

Active Delta-9-THC and Active Pregnenolone

Experimental group

Treatment:

Drug: Active Delta-9-THC

Drug: Active Pregnenolone

Placebo Delta-9-THC and Active Pregnenolone

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Active Pregnenolone

Placebo Delta-9-THC and Placebo Pregnenolone

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo