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

NCT03206463 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 2000020272
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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).

Conditions

Delta-9-Tetrahydroncannabinol; Bipolar Disorder; Healthy Controls

Outcome Measures

Primary Outcomes (2)

• Change in Verbal memory

  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.

  baseline and +35 mins after drug administration

• Change in Executive functioning

  Executive functioning will be measured by the CogState battery and/or Trails Making Test-Part B.

  baseline and +35 mins after drug administration

Secondary Outcomes (6)

• Attention

  baseline and +35 mins after drug administration

• Working memory

  baseline, +35 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration

• Mood

  baseline and +20 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration

• Psychotic-type experiences

  baseline and +20 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration

• Anxiety symptoms

  baseline and +20 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration

Other Outcomes (5)

• Blood serum hormonal levels • Serum prolactin, serum ACTH, serum cortisol and serum endocannabinoid levels. • Serum prolactin, serum ACTH, serum cortisol and serum endocannabinoid levels.

  baseline, +20 mins after drug administration, +30 mins after drug administration, +60 mins after drug administration, +90 mins after drug administration, +150 mins after drug administration, +210 mins after drug administration

• Blood serum THC and metabolite levels (ng/ml)

  baseline, +20 mins after drug administration, +30 mins after drug administration, +60 mins after drug administration, +90 mins after drug administration, +150 mins after drug administration, +210 mins after drug administration

• Blood pressure

  baseline, -60 mins before drug administration, +2, +4, +6, +8,+10, +20, +30, +35, +40, +45, +50, +60, +90, +150, +210 mins after drug administration.

Study Arms (3)

Active 4 mg inhaled THC

EXPERIMENTAL

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: 4 mg Delta-9-THC

Active 2 mg inhaled THC

EXPERIMENTAL

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.

Drug: 2 mg Delta-9-THC

Placebo

PLACEBO COMPARATOR

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: Placebo

Interventions

4 mg Delta-9-THC 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 4 mg inhaled THC

Placebo 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.

Placebo

2 mg Delta-9-THC 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.

Active 2 mg inhaled THC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged 18-55 years (extremes included).
• Able to provide informed consent in English.
• A diagnosis of BD type I or BD type II and good physical health.
• Current euthymic state for at least 4 weeks.
• Men and women aged approximately 18-55 years (extremes included).
• Able to provide informed consent in English.
• No psychiatric diagnoses and in good physical health.

You may not qualify if:

• Cannabis naïve
• Unwillingness to remain alcohol-free, cannabis-free for at least 1 week (in infrequent cannabis users) prior to each test day.
• Evidence of a hearing deficit.
• IQ less than 80.
• Positive pregnancy test, lactation, and refusal to practice birth control.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Biological Studies Unit, VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Mohini Ranganathan, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: July 2, 2017
• Study Start: August 1, 2017
• Primary Completion: September 29, 2017
• Study Completion: September 29, 2017
• Last Updated: January 31, 2022

Record last verified: 2022-01

Locations

US (1)