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

Phase 1

Terminated

• Conditions: Delta-9-Tetrahydroncannabinol; Bipolar Disorder; Healthy Controls
• Interventions: Drug: Placebo; Drug: 4 mg Delta-9-THC; Drug: 2 mg Delta-9-THC

• Registration Number: NCT03206463
• Lead Sponsor: Yale University

Brief 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.

Study Timeline

• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-28
• Study First Posted: 2017-07-02
• Study Start: 2017-08-01
• Primary Completion: 2017-09-29
• Study Completion: 2017-09-29
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Active 4 mg inhaled THC	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.
Active 2 mg inhaled THC	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.

Primary Outcome Measures

Name	Time	Method
Change in Verbal memory	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.
Change in Executive functioning	baseline and +35 mins after drug administration	Executive functioning will be measured by the CogState battery and/or Trails Making Test-Part B.

Secondary Outcome Measures

Name	Time	Method
Attention	baseline and +35 mins after drug administration	Attention will be measured by the Continuous Performance Test-Identical Pairs (CPT-IP).
Working memory	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.
Mood	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).
Psychotic-type experiences	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).
Anxiety symptoms	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).
Impulsivity	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).

Trial Locations

Locations (1)

Biological Studies Unit, VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States