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Trial record 29 of 55 for:    Recruiting, Not yet recruiting, Available Studies | NOT (Use Disorders OR Marijuana Use OR Dependence OR Abuse OR Drug Use) | cannabinoids

Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone: Sub-Study I (THC-PREG-I)

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ClinicalTrials.gov Identifier: NCT02811939
Recruitment Status : Recruiting
First Posted : June 23, 2016
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 Dronabinol (THC).

Condition or disease Intervention/treatment Phase
Healthy Drug: Active Dronabinol Drug: Active Pregnenolone Drug: Placebo Dronabinol Drug: Placebo Pregnenolone 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: Sub-Study I
Study Start Date : March 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active THC and Placebo Pregnenolone Drug: Active Dronabinol
20 mg capsule of Dronabinol will be administered orally

Drug: Placebo Pregnenolone
Control: Placebo given sublingually (under the tongue)

Experimental: Active THC and Active Pregnenolone Drug: Active Dronabinol
20 mg capsule of Dronabinol will be administered orally

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

Experimental: Placebo THC and Active Pregnenolone Drug: Active Pregnenolone
1.79 mg/kg of Pregnenolone will be administered sublingually (under the tongue)

Drug: Placebo Dronabinol
Control: Placebo pill (no active cannabinoids) administered orally

Placebo Comparator: Placebo THC and Placebo Pregnenolone Drug: Placebo Dronabinol
Control: Placebo pill (no active cannabinoids) administered orally

Drug: Placebo Pregnenolone
Control: Placebo given sublingually (under the tongue)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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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 naïve
  • Individuals with a documented reaction/allergy to Pregnenolone
  • Individuals with a documented reaction/allergy to Sesame oil

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): NCT02811939


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 Cyril D'Souza, MD         
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Deepak Cyril D'Souza, MD Yale Univerisity, School of Medicine

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Responsible Party: Deepak C. D'Souza, Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT02811939     History of Changes
Other Study ID Numbers: 1501015242.A
First Posted: June 23, 2016    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
Dronabinol
Pregnenolone
PREG
Psychotic Disorders
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