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Clinical Trial Summary

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).


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT03206463
Study type Interventional
Source Yale University
Contact
Status Terminated
Phase Phase 1
Start date August 1, 2017
Completion date September 29, 2017

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