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Completed

NCT Number: NCT02576912

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

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.

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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 naive
  • Individuals with a documented reaction/allergy to Pregnenolone

Treatment and study plan

Active Delta-9-THC

Drug

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

Active Pregnenolone

Drug

A dose given sublingually.

Placebo

Drug

A placebo dose given sublingually.

Primary outcomes

  1. Positive and Negative Syndrome Scale for Schizophrenia (PANSS)

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

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

Secondary outcomes

  1. Clinician Administered Dissociative Symptoms Scale (CADSS)

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

    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.

  2. Visual Analog Scale (VAS)

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

    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. These data will be captured to validate that the experiment is relevant to cannabis effects.

  3. Psychotomimetic States Inventory (PSI)

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

    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.

  4. Cognitive Test Battery

    Time frame: 25 minutes after start of THC infusion

    Several computer tasks will be administered in order to evaluate the effects of cannabis on verbal learning and memory, visual recognition, spatial working memory, and working memory. The battery consists of five computer tasks that lasts no longer than 20 minutes in total.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Acronym: THC-Preg

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 15, 2015
Registry last updated
Aug 7, 2023

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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