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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
2
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.
Biological Studies Unit, VA Connecticut Healthcare System
West Haven, Connecticut, United States
Change in Verbal memory
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
Change in Executive functioning
Executive functioning will be measured by the CogState battery and/or Trails Making Test-Part B.
Time frame: baseline and +35 mins after drug administration
Attention
Attention will be measured by the Continuous Performance Test-Identical Pairs (CPT-IP).
Time frame: baseline and +35 mins after drug administration
Working memory
Working memory will be tested by the Wechsler Memory Scale-3 Letter-Number Sequencing.
Time frame: baseline, +35 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Mood
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
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
Anxiety symptoms will be measured by the Visual Analog Scale for Anxiety (VAS-A).
Time frame: baseline and +20 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Impulsivity
Impulsivity will be measured by the Balloon Analogue Risk Task (BART).
Time frame: baseline, +35 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.