Active Dronabinol
20 mg capsule of Dronabinol will be administered orally
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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).
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2022-03-02
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
20 mg capsule of Dronabinol will be administered orally
1.79 mg/kg of Pregnenolone will be administered sublingually (under the tongue)
Control: Placebo pill (no active cannabinoids) administered orally
Control: Placebo given sublingually (under the tongue)
Eligibility
primary outcomes
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 outcomes
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.
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.
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.
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.
Publications
No exact PMID-linked public article is currently readable locally.