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

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT02811939

Collaborator

(none)

Enrollment

Location

Arms

14.1

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Active Dronabinol Drug: Active Pregnenolone Drug: Placebo Dronabinol Drug: Placebo Pregnenolone	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Apr 7, 2016

Actual Primary Completion Date :

Jun 9, 2017

Actual Study Completion Date :

Jun 9, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active THC and Placebo Pregnenolone	Drug: Active Dronabinol 20 mg capsule of Dronabinol will be administered orally Drug: Placebo Pregnenolone Control: Placebo given sublingually (under the tongue)
Experimental: Active THC and Active Pregnenolone	Drug: Active Dronabinol 20 mg capsule of Dronabinol will be administered orally Drug: Active Pregnenolone 1.79 mg/kg of Pregnenolone will be administered sublingually (under the tongue)
Experimental: Placebo THC and Active Pregnenolone	Drug: Active Pregnenolone 1.79 mg/kg of Pregnenolone will be administered sublingually (under the tongue) Drug: Placebo Dronabinol Control: Placebo pill (no active cannabinoids) administered orally
Placebo Comparator: Placebo THC and Placebo Pregnenolone	Drug: Placebo Dronabinol Control: Placebo pill (no active cannabinoids) administered orally Drug: Placebo Pregnenolone Control: Placebo given sublingually (under the tongue)

Outcome Measures

Primary Outcome Measures

Change from Baseline: Positive and Negative Syndrome Scale (PANSS) [baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo]
Positive, negative and general symptoms will be assessed using the positive, negative, and general symptom subscale of the PANSS.

Secondary Outcome Measures

Change from Baseline: Clinician Administered Dissociative Symptoms Scale (CADSS) [baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo]
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.
Change from Baseline: Visual Analog Scale (VAS) [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]
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.
Change from Baseline: Psychotomimetic States Inventory (PSI) [baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo]
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.
Cognitive Test Battery [25 minutes after Dronabinol is given orally]
Several computer tasks will be administered in order to evaluate the effects of cannabis on verbal learning and memory. The battery consists of five computer tasks that last no longer than 20 minutes in total.