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Cognitive and Psychophysiological Effects of Delta-9-Tetrahydrocannabinol in Bipolar Disorder (THC-BD)

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ClinicalTrials.gov Identifier: NCT03206463
Recruitment Status : Active, not recruiting
First Posted : July 2, 2017
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University

Tracking Information
First Submitted Date  ICMJE June 19, 2017
First Posted Date  ICMJE July 2, 2017
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE August 1, 2017
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2017)
  • Change in Verbal memory [ Time Frame: 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 [ Time Frame: baseline and +35 mins after drug administration ]
    Executive functioning will be measured by the CogState battery and/or Trails Making Test-Part B.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03206463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2017)
  • Attention [ Time Frame: baseline and +35 mins after drug administration ]
    Attention will be measured by the Continuous Performance Test-Identical Pairs (CPT-IP).
  • Working memory [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 28, 2017)
  • Blood serum hormonal levels • Serum prolactin, serum ACTH, serum cortisol and serum endocannabinoid levels. • Serum prolactin, serum ACTH, serum cortisol and serum endocannabinoid levels. [ Time Frame: 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 ]
    As an exploratory aim, serum prolactin (ng/mL), serum ACTH (pg/ml), and serum cortisol (μg/dL) levels will be measured to provide an objective measure of THC effects on the hypothalamic pituitary adrenal (HPA) axis.
  • Blood serum THC and metabolite levels (ng/ml) [ Time Frame: 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 levels of THC and both its active and inactive metabolites will be assayed to explore the gender related differences in the metabolism of THC.
  • Blood pressure [ Time Frame: 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. ]
    Blood pressure (mmHg) will be assessed as part of the medical monitoring of the subjects
  • Pulse [ Time Frame: 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. ]
    Pulse (beats per min) will be assessed as part of the medical monitoring of the subjects
  • Genetics [ Time Frame: Only on 1st test day ]
    Blood samples for DNA extraction will be collected to examine whether any of the genes implicated in cognition in the response to cannabinoids (e.g., COMT, CNR1, FAAH, BDNF) modify the effects of THC.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Cognitive and Psychophysiological Effects of Delta-9-Tetrahydrocannabinol in Bipolar Disorder
Official Title  ICMJE Cognitive and Psychophysiological Effects of Delta-9-Tetrahydrocannabinol in Bipolar Disorder
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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
Condition  ICMJE
  • Delta-9-Tetrahydroncannabinol
  • Bipolar Disorder
  • Healthy Controls
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: 4 mg Delta-9-THC
  • Experimental: 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.
    Intervention: Drug: 2 mg Delta-9-THC
  • Placebo Comparator: 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: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 28, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for individuals with Bipolar Disorder (BD)

  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.

Inclusion Criteria for Healthy Control (HC) individuals:

  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.

General 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03206463
Other Study ID Numbers  ICMJE 2000020272
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mohini Ranganathan, Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohini Ranganathan, MD Yale University
PRS Account Yale University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP