Verified June 2016 by Yale University
Sponsor:
Information provided by (Responsible Party):
Deepak C. D’Souza, Yale University
ClinicalTrials.gov Identifier:
NCT02811939
First received: March 15, 2016
Last updated: June 20, 2016
Last verified: June 2016
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).
| Healthy | Drug: Active Dronabinol Drug: Active Pregnenolone Drug: Placebo Dronabinol Drug: Placebo Pregnenolone |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone: Sub-Study I |
- 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 ] [ Designated as safety issue: No ]
Positive, negative and general symptoms will be assessed using the positive, negative, and general symptom subscale of the PANSS.
- 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 19 |
| Study Start Date: | March 2016 |
| Estimated Study Completion Date: | February 2018 |
| Estimated Primary Completion Date: | February 2018 (Final data collection date for primary outcome measure) |
| 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) |
| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02811939
| Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine | |
| West Haven, Connecticut, United States, 06516 | |
| Contact: Esra Sefik, BA 203-932-5711 ext 2557 esra.sefik@nullyale.edu | |
| Contact: Christina Luddy, BS (203) 932-5711 ext 4549 christina.luddy@nullyale.edu | |
| Principal Investigator: Deepak Cyril D’Souza, MD | |
Yale University
| Principal Investigator: | Deepak Cyril D’Souza, MD | Yale Univerisity, School of Medicine |
| Responsible Party: | Deepak C. D’Souza, Professor of Psychiatry, Yale University |
| ClinicalTrials.gov Identifier: | NCT02811939 History of Changes |
| Other Study ID Numbers: | 1501015242.A |
| Study First Received: | March 15, 2016 |
| Last Updated: | June 20, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Yale University:
| Cannabis Marijuana THC Dronabinol |
Pregnenolone PREG Psychotic Disorders |
Additional relevant MeSH terms:
| 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 |
ClinicalTrials.gov processed this record on September 13, 2016