Completed

NCT Number: NCT02811939

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

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Key information

Conditions

Healthy Chemically-Induced Disorders Marijuana Abuse Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

West Haven, Connecticut, 06516, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Dronabinol

Drug

20 mg capsule of Dronabinol will be administered orally

Active Pregnenolone

Drug

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

Placebo Dronabinol

Drug

Control: Placebo pill (no active cannabinoids) administered orally

Placebo Pregnenolone

Drug

Control: Placebo given sublingually (under the tongue)

Primary outcomes

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

Time frame: 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 outcomes

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

Time frame: 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)

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

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)

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Acronym: THC-PREG-I

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jun 23, 2016
Registry last updated: Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed