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

NCT ID: NCT03206463

Last Updated: 2022-01-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2017-09-29

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.

Conditions

Delta-9-Tetrahydroncannabinol; Bipolar Disorder; Healthy Controls

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Active 4 mg inhaled 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.

Group Type: EXPERIMENTAL

4 mg Delta-9-THC

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

2 mg Delta-9-THC

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Men and women aged 18-55 years (extremes included).

2. Able to provide informed consent in English.

3. A diagnosis of BD type I or BD type II and good physical health.

4. Current euthymic state for at least 4 weeks.

1. Men and women aged approximately 18-55 years (extremes included).

2. Able to provide informed consent in English.

3. No psychiatric diagnoses and in good physical health.

Exclusion Criteria

1. Cannabis naïve

2. Unwillingness to remain alcohol-free, cannabis-free for at least 1 week (in infrequent cannabis users) prior to each test day.

3. Evidence of a hearing deficit.

4. IQ less than 80.

5. Positive pregnancy test, lactation, and refusal to practice birth control.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Mohini Ranganathan

Assistant Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohini Ranganathan, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Biological Studies Unit, VA Connecticut Healthcare System

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

2000020272

Identifier Type: -

Identifier Source: org_study_id