Cognitive and Psychophysiological Effects of Delta-9-Tetrahydrocannabinol in Bipolar Disorder
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bipolar Disorder
- Delta-9-Tetrahydroncannabinol
- Healthy Controls
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: The study is a double-blind, randomized, placebo-controlled, crossover laboratory evaluation of the acute subjective, cognitive and psychophysiological effects of 2 mg and 4 mg inhaled THC in Healthy Control individuals and individuals with euthymic Bipolar Disorder.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
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 modif...
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.
Tracking Information
- NCT #
- NCT03206463
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Mohini Ranganathan, MD Yale University
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