Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone: Sub-Study I

Phase 1CompletedNCT02811939

Yale University13 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

Active DronabinolDRUG

20 mg capsule of Dronabinol will be administered orally

Active PregnenoloneDRUG

1.79 mg/kg of Pregnenolone will be administered sublingually (under the tongue)

Placebo DronabinolDRUG

Control: Placebo pill (no active cannabinoids) administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

West Haven, Connecticut, United States

Outcomes

Primary Outcomes

Change from Baseline: Positive and Negative Syndrome Scale (PANSS)

Positive, negative and general symptoms will be assessed using the positive, negative, and general symptom subscale of the PANSS.

Time frame: baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo

Secondary Outcomes

Change from Baseline: Clinician Administered Dissociative Symptoms Scale (CADSS)

Perceptual alterations will be measured using the CADSS. This is a scale consisting of 19 self-reported items, and 9 clinician-rated items. The scale captures alterations in environmental/time/body perception, feelings of unreality, and memory impairment.

Time frame: baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo

Change from Baseline: Visual Analog Scale (VAS)

Feeling states associated with cannabis intoxication will be measured using a self-reported visual analog scale of feeling states associated with cannabis effects (ex. "high, "calm", "anxious"). Subjects will be asked to score the perceived intensity of these feeling states at that moment on a 11mm line. This data will be captured to validate the experiment is relevant to cannabis effect.

Time frame: Baseline; 30 minutes and 10 minutes prior to administration of oral dronabinol or placebo; 20, 90, 110, 150, 180, and 240 minutes after the administration of oral dronabinol/placebo

Change from Baseline: Psychotomimetic States Inventory (PSI)

The PSI is a measure of drug induced psychotomimetic states. This self-reported scale consists of 28 items rated 0 (not at all) to 3 (extremely) and will facilitate the characterization of a wide range of dissociative/hallucinatory phenomena as well as cognitive disorganization associated with the administration of THC.

Time frame: baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo

Data from ClinicalTrials.gov

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