Effects of Nabilone on Trauma Related Cue Reactivity in Cannabis Users With PTSD
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Cue Reactivity (Emotional Stroop Task)
研究概览
简要总结
Despite the prevalence of cannabis use among the PTSD population and self-reports that it is used to help cope with PTSD symptoms, the direct effects of cannabis on PTSD symptomology are unknown. The purpose of this placebo-controlled, within-subject study is to assess the effects of smoked cannabis and orally administered nabilone, a synthetic analog of THC, the primary psychoactive component of cannabis on multiple dimensions of PTSD symptomatology in cannabis smokers with PTSD.
详细描述
This study will compare the effects of smoked cannabis and nabilone on attentional bias toward trauma- related stimuli, subjective and emotional processing to a range of trauma-and non-trauma-related images and physiological reactivity to these stimuli in individuals with CUD and PTSD. Importantly, this study will also probe the abuse related potential of nabilone compared to smoked cannabis in this population, a critical aspect in determining the potential feasibility for its use clinically to treat CUD in PTSD populations. The effects of nabilone will be compared to propranolol as a positive control.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current cannabis use
- •PTSD symptoms
- •Able to give informed consent and comply with study procedures
- •Women who are normally cycling and practicing an effective form of birth control other than hormonal contraceptives
排除标准
- •Meeting criteria for certain current psychiatric disorders
- •Clinical laboratory tests outside of normal limits
- •History of clinically significant cardiac or respiratory diagnoses
- •Current parole or probation
- •Women who are currently pregnant or breastfeeding
研究组 & 干预措施
Nabilone
Nabilone capsules (4 mg)
干预措施: Nabilone (Drug)
Propranolol
Propranolol capsules (40mg)
干预措施: Propranolol (Drug)
Smoked cannabis
(0.0 and 5.6% THC)
干预措施: Cannabis (Drug)
Placebo
Placebo capsules
干预措施: Placebo (Drug)
结局指标
主要结局
Cue Reactivity (Emotional Stroop Task)
时间窗: 1 month
We cannot provide data as the study was terminated due to lack of feasibility. The staff responsible for data collection, organization, and cleaning have left the institution; we have made every effort to locate the data for the two participants who completed the study, but have been unsuccessful. We do not have access to the data.
次要结局
未报告次要终点
研究者
Margaret Haney
Professor of Neurobiology (in Psychiatry) at CUMC
New York State Psychiatric Institute