Measuring Acute Drug Demand in Humans II
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Demand Intensity - Consumption of Blinded Drug at Unconstrained Price as Measured by a Demand Task
研究概览
简要总结
This research is being done to evaluate the impact of various drugs and combinations of drugs on mood, pain, and performance.
详细描述
This research is being done to evaluate the impact of various drugs and combinations of drugs on mood, pain, and performance. Participants will complete 1 screening visit and 7 study test sessions. During the study sessions the participant will receive a study drug that may contain blinded drugs or drug combinations. Participants will answer questions about how the participant feels, perform tasks that measure the participant's cognitive ability and experience of pain, and have heart rate and blood pressure measured. While not at the laboratory, participants will be asked to wear a wristwatch that measures sleep and activity and complete questions about sleep.
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, 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
- •Aged 18-55 years
- •Vital signs in normal range as reviewed by study medical team
- •Person is willing and able to provide informed consent
排除标准
- •Evidence of physical dependence on alcohol or benzodiazepines based on tolerance and withdrawal upon cessation of use of alcohol or benzodiazepines reported in the Mini-International Neuropsychiatric Interview (MINI) as well as clinical interviews by medical staff during H&P.
- •Seeking treatment for alcohol or substance use
- •Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity
- •Active hepatic disease or abnormal liver function tests
- •Current major depressive disorder or suicidality
- •Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding. People of childbearing potential will be asked to ensure, and/or the partner use effective forms of contraception for the duration of the study and excluded if unable.
- •Are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.
- •Contraindications or allergies to study medications
- •Evidence of recent illicit substance use (i.e., positive urinalysis) at screening for drugs other than cannabis
- •Seizure disorder or traumatic brain injury (TBI)
- •Taking medications known to interact with study medications
研究组 & 干预措施
Experimental Session 1
This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.
干预措施: Blinded Study Medication - Condition 1 (Drug)
Experimental Session 2
This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.
干预措施: Blinded Study Medication - Condition 2 (Drug)
Experimental Session 3
This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.
干预措施: Blinded Study Medication - Condition 3 (Drug)
Experimental Session 4
This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.
干预措施: Blinded Study Medication - Condition 4 (Drug)
Experimental Session 5
This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.
干预措施: Blinded Study Medication - Condition 5 (Drug)
Experimental Session 6
This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.
干预措施: Placebo (Drug)
结局指标
主要结局
Demand Intensity - Consumption of Blinded Drug at Unconstrained Price as Measured by a Demand Task
时间窗: Upon completion of experimental session (~8 hours post drug administration)
Consumption of blinded drug at unconstrained price as measured by a demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more drug consumption at unconstrained price (a worse outcome).
Breakpoint - Maximum price paid for blinded drug as measured by a demand task
时间窗: Upon completion of experimental session (~8 hours post drug administration)
Maximum price paid for blinded drug as measured by a demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate higher price paid (a worse outcome).
Cold Pressor Pain - Seconds to withdraw hand from cold pressor
时间窗: Baseline and 1, 2, 4, and 6 hours post drug administration
Seconds to withdraw hand from cold pressor laboratory pain task, where longer time periods reflect higher tolerance to pain.
Cognitive Performance assessed by Digit Symbol Substitution Test (DSST)
时间窗: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, and 8 hours post drug administration.
Within-subject comparison of study conditions on the Digit Symbol Substitution Test (DSST), a measure of cognitive performance that is sensitive to drug effects, wherein lower percent scores reflect worse performance and suggest greater drug-related impairment.
次要结局
- Drug Liking assessed by Visual Analog Scale of Drug Liking(Upon completion of experimental session (~9 hours post drug administration))