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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Active Pregnenolone; Drug: Active Delta-9-THC; Drug: Placebo

• Registration Number: NCT02576912
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-15
• Primary Completion: 2019-06-24
• Study Completion: 2019-06-24
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Exposed to cannabis at least once in lifetime.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Delta-9-THC and Active Pregnenolone	Active Pregnenolone	-
Placebo Delta-9-THC and Active Pregnenolone	Placebo	-
Active Delta-9-THC and Placebo Pregnenolone	Active Delta-9-THC	-
Active Delta-9-THC and Placebo Pregnenolone	Placebo	-
Active Delta-9-THC and Active Pregnenolone	Active Delta-9-THC	-
Active Delta-9-THC and Active Pregnenolone	Active Pregnenolone	-
Placebo Delta-9-THC and Placebo Pregnenolone	Placebo	-

Primary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)	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 Outcome Measures

Name	Time	Method
Clinician Administered Dissociative Symptoms Scale (CADSS)	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.
Psychotomimetic States Inventory (PSI)	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.
Visual Analog Scale (VAS)	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.
Cognitive Test Battery	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.

Trial Locations

Locations (1)

Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine; 🇺🇸 West Haven, Connecticut, United States