Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone

NCT02576912 | Completed Phase 1

• 1 other identifier: 1501015242
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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 THC.

Conditions

Healthy

Keywords

Cannabis; Marijuana; THC; Pregnenolone; Psychotic Disorders; PREG

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Syndrome Scale for Schizophrenia (PANSS)

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

  Baseline, +110, +180, and +240 minutes after start of THC Infusion

Secondary Outcomes (4)

• Clinician Administered Dissociative Symptoms Scale (CADSS)

  Baseline; +15, +110, +180, and +240 minutes after start of THC infusion

• Visual Analog Scale (VAS)

  Baseline; +15, +110, +180, and +240 minutes after start of THC infusion

• Psychotomimetic States Inventory (PSI)

  Baseline; +110, +180, and +240 minutes after start of THC infusion

• Cognitive Test Battery

  25 minutes after start of THC infusion

Study Arms (4)

Active Delta-9-THC and Placebo Pregnenolone

EXPERIMENTAL

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

Active Delta-9-THC and Active Pregnenolone

EXPERIMENTAL

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

Placebo Delta-9-THC and Active Pregnenolone

EXPERIMENTAL

Drug: Active Pregnenolone; Drug: Placebo

Placebo Delta-9-THC and Placebo Pregnenolone

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Active Delta-9-THC DRUG

Active Delta-9-THC (0.036 mg/kg) given intravenously.

Active Delta-9-THC and Active Pregnenolone; Active Delta-9-THC and Placebo Pregnenolone

Active Pregnenolone DRUG

A dose given sublingually.

Active Delta-9-THC and Active Pregnenolone; Placebo Delta-9-THC and Active Pregnenolone

Placebo DRUG

A placebo dose given sublingually.

Active Delta-9-THC and Placebo Pregnenolone; Placebo Delta-9-THC and Placebo Pregnenolone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Exposed to cannabis at least once in lifetime.

You may not qualify if:

• Cannabis naive
• Individuals with a documented reaction/allergy to Pregnenolone

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

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

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Marijuana Abuse; Psychotic Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Deepak C D'Souza, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: October 15, 2015
• Study Start: February 1, 2015
• Primary Completion: June 24, 2019
• Study Completion: June 24, 2019
• Last Updated: August 7, 2023

Record last verified: 2023-08

Locations

US (1)