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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Active Dronabinol; Drug: Placebo Pregnenolone; Drug: Active Pregnenolone; Drug: Placebo Dronabinol

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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 Pregnenolone; Control: Placebo given sublingually (under the tongue); Drug: Placebo Dronabinol; Control: Placebo pill (no active cannabinoids) administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo
Cognitive Test Battery	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.	25 minutes after Dronabinol is given orally

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Deepak Cyril D'Souza, MD, Yale Univerisity, School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2016
• Primary Completion (Actual): June 9, 2017
• Study Completion (Actual): June 9, 2017

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: June 20, 2016
• First Posted (Estimate): June 23, 2016

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Cannabis; THC; Marijuana; Dronabinol; Pregnenolone; PREG; Psychotic Disorders
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol
• Other Study ID Numbers: 1501015242.A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No