A Double-Blind Randomized Controlled Trial of Daridorexant for Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Total Sleep Time (Minutes)
研究概览
简要总结
This study will test whether the dual orexin receptor antagonist (DORA) daridorexant reduces alcohol craving and use and improves total sleep time among patients with co-occurring alcohol use disorder and sleep disturbance. The study will assess the role of the orexin system in modulating alcohol craving and use in a real-world treatment setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current moderate or severe DSM-5 criteria for AUD at the time of the screening session
- •Evidence of clinically significant sleep disturbance, based on the Pittsburgh Sleep Quality Index (PSQI; i.e., score >5)
- •Aged 18 years or older
- •Willingness to comply with all components of the study protocol
- •Use of birth control throughout the study, if a pre-menopausal female who is not sterile, and who is sexually active with a male partner or considering being sexually active with a male partner
- •Report ability to access a computer with an internet connection during the outpatient phase of the study to complete virtual outpatient visits
- •Report a desire to quit or reduce drinking (i.e., not enrolling in treatment solely to satisfy an external requirement)
- •Able to provide informed consent, and evidence an understanding of study procedures based on a quiz following informed consent
- •Fluent in English (in order to complete study assessments).
排除标准
- •Current moderate or severe substance use disorder other than AUD, cannabis use disorder, nicotine use disorder, or caffeine use disorder
- •Pregnant or breastfeeding, or planning to become pregnant during the study
- •Known allergy to any DORA
- •Past 30-day use of any DORA
- •Current use of benzodiazepines or other schedule IV medications for insomnia
- •Use of any medications that are contraindicated for use with daridorexant
- •Current withdrawal symptoms, as assessed by a score >8 on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar) and benzodiazepine administration in the past 24 hours
- •Past-year suicidal behavior
- •Current bipolar disorder or psychotic disorder
- •Abnormal liver enzyme levels (i.e., AST or ALT greater than five times above the upper limit of normal, or bilirubin greater than two times the upper limit of normal), as assessed during standard intake procedures at Ashley Addiction Treatment
- •AHI>30, as assessed using a wireless EEG/apnea device, to rule out those with severe sleep apnea
- •Any other medical or psychological condition that is judged by the investigators to impede ability to safely complete study requirements
- •Legal problems or living situation judged by the investigators as a factor that could interfere with study completion (e.g., impending jail time).
研究组 & 干预措施
Placebo
Placebo (Oral)
干预措施: Placebo (Other)
Daridorexant
Daridorexant 50mg (Oral)
干预措施: Daridorexant 50 mg (Drug)
结局指标
主要结局
Total Sleep Time (Minutes)
时间窗: Enrollment to one month follow-up
Total sleep time will be assessed through both wireless EEG and ambulatory monitoring. Wireless EEG will be assessed during the residential phase only. Ambulatory monitoring will occur during both the residential and outpatient phase.
Alcohol Craving Visual Analogue Scale
时间窗: Enrollment to one month follow-up
Visual Analogue Scales assessing alcohol craving will be administered (Range 0-100, higher scores indicate greater craving).
Daily alcohol use, assessed via Timeline Followback (TLFB)
时间窗: Outpatient phase (Day 1 post-residential treatment to one-month follow-up)
Number of Adverse Events
时间窗: From enrollment to one month follow-up
次要结局
- Daily binge drinking, assessed via Timeline Followback (TLFB)(Outpatient phase (Day 1 post-residential treatment to one-month follow-up))
- Number of Participants with Positive breathalyzer screen(Outpatient phase (Day 1 post-residential treatment to one-month follow-up))
- Number of Alcohol use disorder symptoms(Enrollment to one-month follow-up)
- Self-Reported Insomnia Severity(Enrollment to one-month follow-up)