Cognitive and Psychophysiological Effects of Delta-9-Tetrahydrocannabinol in Bipolar Disorder
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Healthy Studies, Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 6/28/2018 |
| Start Date: | August 1, 2017 |
| End Date: | July 2019 |
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).
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).
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.
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.
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.
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