NCT03206463

Cognitive and Psychophysiological Effects of Delta-9-Tetrahydrocannabinol in Bipolar Disorder

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Delta-9-Tetrahydroncannabinol
• Bipolar Disorder
• Healthy Controls

Interventions

Type	Name	Description
DRUG	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.
DRUG	Placebo	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.
DRUG	2 mg Delta-9-THC	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.

Timeline

• Start date: 2017-08-01
• Primary completion: 2017-09-29
• Completion: 2017-09-29
• First posted: 2017-07-02
• Last updated: 2022-01-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study