Influence of Orexin Antagonism on Motivation for Alcohol
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Reinforcing Effects of Alcohol
研究概览
简要总结
This research will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of alcohol in humans. As such, the outcomes will contribute to our understanding of the clinical neurobiology of Alcohol Use Disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on alcohol addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 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
- •Able to speak and read English.
- •Not seeking treatment at the time of the study.
- •Between the ages of 21 and 55 years.
- •Engaging in at least one binge drinking episode, per the NIAAA definition, in the last 30 days.
- •Fulfillment of moderate or severe DSM-5 diagnostic criteria for AUD based on computerized SCID results reviewed by a psychiatrist or psychologist.
- •ECG, read by cardiologist, within normal limits.
- •Body mass index of 19 -
- •Birthing individuals using an effective form of birth control and not pregnant or breast feeding.
- •Judged by the medical staff to be psychiatrically and physically healthy (i.e., no current severe SUD or psychiatric diagnoses other than AUD or Tobacco Use Disorder; no current physical diagnoses that would interfere with study participation according to study physician judgment).
- •Not currently physiologically dependent on any substances.
- •Able to abstain from alcohol during admission (i.e., not physically dependent on alcohol and scores less than 8 on Clinical Institute Withdrawal Assessment for Alcohol [CIWA-Ar] at screening).
- •Not currently taking any prescribed medications for a chronic condition (other than birth control).
- •No indication of sleep apnea on the STOP-Bang questionnaire (score of 5 or greater).
- •No contraindications/allergies to suvorexant.
研究组 & 干预措施
Suvorexant Dose 1
Subjects will be treated daily with oral suvorexant (10 mg).
干预措施: Alcohol (Drug)
Placebo
Subjects will be treated daily with an oral placebo.
干预措施: Placebo (Drug)
Placebo
Subjects will be treated daily with an oral placebo.
干预措施: Alcohol (Drug)
Suvorexant Dose 1
Subjects will be treated daily with oral suvorexant (10 mg).
干预措施: Suvorexant (Drug)
Suvorexant Dose 2
Subjects will be treated daily with oral suvorexant (20 mg).
干预措施: Alcohol (Drug)
Suvorexant Dose 2
Subjects will be treated daily with oral suvorexant (20 mg).
干预措施: Suvorexant (Drug)
结局指标
主要结局
Reinforcing Effects of Alcohol
时间窗: 6 times over approximately 3 week inpatient admission.
Number of Times Subjects Choose Alcohol (Maximum of 5 Choices) Over Money
次要结局
- Craving(6 times over approximately 3 week inpatient admission.)
- Mood(6 times over approximately 3 week inpatient admission.)
- Alcohol Response(6 times over approximately 3 week inpatient admission.)
- Heart rate(Daily over approximately 3 week inpatient admission.)
- Blood pressure(Daily over approximately 3 week inpatient admission.)
- Breath Alcohol Level(Daily over approximately 3 week inpatient admission.)
- Temperature(Daily over approximately 3 week inpatient admission.)
- Side Effects(Daily over approximately 3 week inpatient admission.)
- Delay Discounting(6 times over approximately 3 week inpatient admission.)
- n-back Task(6 times over approximately 3 week inpatient admission.)
- Stop-Signal Task Inhibitory Failures(6 times over approximately 3 week inpatient admission.)
- Sleep(Daily over approximately 3 week inpatient admission.)
研究者
William Stoops
Professor
University of Kentucky