Measuring Acute Drug Demand in Humans
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Demand Elasticity
研究概览
简要总结
This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs.
详细描述
This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs. Suvorexant is not approved as a treatment to reduce drug use but is approved by the Food and Drug Administration (FDA) to treat insomnia (trouble falling asleep or staying asleep). This study consists of a screening visit and an approximate 14 to 16 day inpatient (overnight) stay at the University of Maryland, Baltimore. Participants will be stabilized on hydromorphone, randomly assigned to receive either suvorexant or placebo, and complete 5 experimental sessions that include taking blinded study medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 65 years old
- •Meets Diagnostic and Statistical Manual-5 criteria for Opioid Use Disorder (OUD) (moderate or severe)
- •Lifetime substance use history criterion [blinded]
- •Medically cleared to take suvorexant and blinded study medications
- •Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
排除标准
- •Pregnant or breast feeding
- •Seeking opioid use treatment
- •Significant mental health or physical disorder that is expected to interfere with study participation as assessed by the study physicians or medical staff
- •Known contraindications or allergies to suvorexant and/or the blinded study medications
研究组 & 干预措施
Suvorexant (20mg/day)
Double blind administration of suvorexant once per day during residential stay until discharge
干预措施: Drug A (Blinded Drug) (Drug)
Suvorexant (20mg/day)
Double blind administration of suvorexant once per day during residential stay until discharge
干预措施: Drug B (Blinded Drug) (Drug)
Suvorexant (20mg/day)
Double blind administration of suvorexant once per day during residential stay until discharge
干预措施: Drug C (Blinded Drug) (Drug)
Suvorexant (20mg/day)
Double blind administration of suvorexant once per day during residential stay until discharge
干预措施: Drug D (Blinded Drug) (Drug)
Suvorexant (20mg/day)
Double blind administration of suvorexant once per day during residential stay until discharge
干预措施: Suvorexant (20mg/day) (Drug)
Placebo
Double blind administration of placebo once per day during residential stay until discharge
干预措施: Drug A (Blinded Drug) (Drug)
Placebo
Double blind administration of placebo once per day during residential stay until discharge
干预措施: Drug B (Blinded Drug) (Drug)
Placebo
Double blind administration of placebo once per day during residential stay until discharge
干预措施: Drug C (Blinded Drug) (Drug)
Placebo
Double blind administration of placebo once per day during residential stay until discharge
干预措施: Drug D (Blinded Drug) (Drug)
Placebo
Double blind administration of placebo once per day during residential stay until discharge
干预措施: Placebo (Drug)
结局指标
主要结局
Demand Elasticity
时间窗: Upon completion of experimental session (~8 hours post drug administration)
Changes in blinded drug consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater drug price sensitivity (a better outcome).
Demand Intensity
时间窗: Upon completion of experimental session (~8 hours post drug administration)
Consumption of blinded drug at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more drug consumption at unconstrained price (a worse outcome).
Cross-Price Elasticity
时间窗: After Experimental Session 4
Change in consumption of price-fixed good based on change in price of price varying good. Positive values indicate a substitute, negative values indicate a complement, and zero values indicate an independent commodity.
次要结局
- Total Mean Sleep Time(Through study completion, up to two weeks)