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Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone (THC-Preg)

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ClinicalTrials.gov Identifier: NCT02576912
Recruitment Status : Recruiting
First Posted : October 15, 2015
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Deepak C. D'Souza, 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Active Delta-9-THC Drug: Active Pregnenolone Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone
Study Start Date : February 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Delta-9-THC and Placebo Pregnenolone Drug: Active Delta-9-THC
Active Delta-9-THC (0.036 mg/kg) given intravenously.

Drug: Placebo
A placebo dose given sublingually.

Experimental: Active Delta-9-THC and Active Pregnenolone Drug: Active Delta-9-THC
Active Delta-9-THC (0.036 mg/kg) given intravenously.

Drug: Active Pregnenolone
A dose given sublingually.

Experimental: Placebo Delta-9-THC and Active Pregnenolone Drug: Active Pregnenolone
A dose given sublingually.

Drug: Placebo
Placebo dose given intravenously.

Placebo Comparator: Placebo Delta-9-THC and Placebo Pregnenolone Drug: Placebo
A placebo dose given sublingually.

Drug: Placebo
Placebo dose given intravenously.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Exposed to cannabis at least once in lifetime.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576912


Contacts
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Contact: Leigh Taylor Flynn, BS 203-932-5711 ext 2557 leigh.flynn@yale.edu
Contact: Christina Luddy, BS 203-932-5711 ext 4549 christina.luddy@yale.edu

Locations
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United States, Connecticut
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine Recruiting
West Haven, Connecticut, United States, 06516
Contact: Ashley Sanders, BA    203-932-5711 ext 4495    ashley.sanders@yale.edu   
Contact: Christina Luddy, BS    203-932-5711 ext 4549    christina.luddy@yale.edu   
Principal Investigator: Deepak C D'Souza, MD         
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Deepak C D'Souza, MD Yale University

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Responsible Party: Deepak C. D'Souza, Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT02576912     History of Changes
Other Study ID Numbers: 1501015242
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Keywords provided by Deepak C. D'Souza, Yale University:
Cannabis
Marijuana
THC
Pregnenolone
Psychotic Disorders
PREG
Additional relevant MeSH terms:
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Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists