4 mg Delta-9-THC
Subject will have 1/3 chance of receiving 4 mg THC administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing.
Loading study record…
Loading study record…
The overarching goal of this study is to characterize the acute cognitive and psychophysiological effects of the main psychoactive constituent of cannabis, 9-delta-tetrahydrocannabinol (THC) in individuals with euthymic bipolar disorder (BD), and to begin probing the mechanisms that may underlie its effects in this illness. This study is expected to contribute to a better characterization of specific effects of THC in individuals with BD compared to healthy controls (HC).
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2022-01-31
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
To compare the dose related acute effects of inhaled THC, administered through a vaporizer over approximately 20 minutes, between HC and euthymic BD individuals (referred to as eBD) on a range of subjective and objective parameters as described below: Primary Aims: * Verbal memory, measured by a modified computer version of the Rey Auditory Verbal Learning Test (RAVLT) and/or the CogState battery, administered while EEG data is collected. * Executive functioning measured by the CogState battery and/or Trails Making Test-Part B. Secondary Aims: * Attention, measured by the Continuous Performance Test-Identical Pairs (CPT-IP). * Working memory, measured by the Wechsler Memory Scale-3 Letter-Number Sequencing. * Mood, measured by the Profile of Mood States (POMS). * Psychotic-type experiences, measured by the Psychotomimetic States Inventory (PSI) and/or the Clinician Administered Dissociative Symptoms Scale (CADSS). * Anxiety symptoms, measured by the Visual Analog Scale for Anxiety (VAS-A). * Impulsivity, measured by the Balloon Analogue Risk Task (BART). Exploratory aims: •Serum prolactin, serum ACTH, serum cortisol and serum endocannabinoid levels.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Subject will have 1/3 chance of receiving 4 mg THC administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing.
Subject will have 1/3 chance of receiving the inhaled placebo condition administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing. The placebo condition will include no active cannabinoids.
Subject will have 1/3 chance of receiving 2 mg THC administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing.
Eligibility
primary outcomes
Time frame: baseline and +35 mins after drug administration
Verbal memory will be measured by a modified computer version of the Rey Auditory Verbal Learning Test (RAVLT) and/or the CogState battery, administered while EEG data is collected.
Time frame: baseline and +35 mins after drug administration
Executive functioning will be measured by the CogState battery and/or Trails Making Test-Part B.
secondary outcomes
Time frame: baseline and +35 mins after drug administration
Attention will be measured by the Continuous Performance Test-Identical Pairs (CPT-IP).
Time frame: baseline, +35 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Working memory will be tested by the Wechsler Memory Scale-3 Letter-Number Sequencing.
Time frame: baseline and +20 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Mood will be measured by the Profile of Mood States (POMS).
Time frame: baseline and +20 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Psychotic-type experiences will be measured by the Psychotomimetic States Inventory (PSI) and/or the Clinician Administered Dissociative Symptoms Scale (CADSS).
Time frame: baseline and +20 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Anxiety symptoms will be measured by the Visual Analog Scale for Anxiety (VAS-A).
Time frame: baseline, +35 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Impulsivity will be measured by the Balloon Analogue Risk Task (BART).
other outcomes
Time frame: baseline, +20 mins after drug administration, +30 mins after drug administration, +60 mins after drug administration, +90 mins after drug administration, +150 mins after drug administration, +210 mins after drug administration
As an exploratory aim, serum prolactin (ng/mL), serum ACTH (pg/ml), and serum cortisol (μg/dL) levels will be measured to provide an objective measure of THC effects on the hypothalamic pituitary adrenal (HPA) axis.
Time frame: baseline, +20 mins after drug administration, +30 mins after drug administration, +60 mins after drug administration, +90 mins after drug administration, +150 mins after drug administration, +210 mins after drug administration
Blood levels of THC and both its active and inactive metabolites will be assayed to explore the gender related differences in the metabolism of THC.
Time frame: baseline, -60 mins before drug administration, +2, +4, +6, +8,+10, +20, +30, +35, +40, +45, +50, +60, +90, +150, +210 mins after drug administration.
Blood pressure (mmHg) will be assessed as part of the medical monitoring of the subjects
Time frame: baseline, -60 mins before drug administration, +2, +4, +6, +8,+10, +20, +30, +35, +40, +45, +50, +60, +90, +150, +210 mins after drug administration.
Pulse (beats per min) will be assessed as part of the medical monitoring of the subjects
Time frame: Only on 1st test day
Blood samples for DNA extraction will be collected to examine whether any of the genes implicated in cognition in the response to cannabinoids (e.g., COMT, CNR1, FAAH, BDNF) modify the effects of THC.
Publications
No exact PMID-linked public article is currently readable locally.