Cognitive and Psychophysiological Effects of Delta-9-Tetrahydrocannabinol in Bipolar Disorder
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in Verbal memory
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: 4 mg Delta-9-THC (Drug)
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.
干预措施: 2 mg Delta-9-THC (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.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Verbal memory
时间窗: 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
时间窗: baseline and +35 mins after drug administration
Executive functioning will be measured by the CogState battery and/or Trails Making Test-Part B.
次要结局
- 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)
- Impulsivity(baseline, +35 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration)
研究者
Mohini Ranganathan
Assistant Professor of Psychiatry
Yale University