Prescription Opioid Effects in Drug and Non-drug Abusers - 1
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Breakpoint
研究概览
简要总结
The purpose of this study is to examine the abuse liability of oxycodone in individuals with, and without, a history of prescription opioid abuse.
详细描述
Prescription opioid abuse is becoming an increasingly widespread and serious public health concern. The 2001 National Household Survey on Drug Abuse report revealed that the number of first-time users of prescription opioid medications for non-medical reasons reached 2 million in the year 2000, a number that has quintupled since 1984. Despite this trend, little experimental research has been directed towards understanding who may be abusing these medications, and under what conditions. The study will examine the reinforcing, subjective, performance, and physiological effects of oxycodone. Because it is not clear who is abusing prescription opioids, the medication effects will be compared in drug abusers and non-drug abusers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In good physical health
- •Women reporting regular menstrual cycles lasting between 24 to 35 days
- •Able to perform study procedures
- •Normal body weight
- •Use of opioids for medical purposes (cough, pain, or diarrhea) or recreational purposes at least twice in lifetime with no serious adverse effects
- •Current opioid abuse, but not opioid dependence (drug abusers only)
排除标准
- •On parole or probation
- •Recently convicted of a crime of violence
- •History of significant violent behavior
- •Current Axis I psychopathology
- •Significant Axis II disorder
- •Pregnancy
- •Women who have irregular menstrual cycles, or who are dysmenorrheic, amenorrheic, or menopausal
- •Women who have been pregnant or breastfeeding within the past 6 months
- •Women who have had a miscarriage or abortion within the past 6 months
- •Women who meet DSM-IV criteria for premenstrual dysphoric disorder
- •Women who report suffering from moderate to severe premenstrual symptoms
- •Women seeking treatment for premenstrual problems
- •Taking prescription or over-the-counter psychotropic medication
- •History of chronic pain, or routinely uses over-the-counter analgesics (more than 4 days per month)
- •Blood pressure greater than 150/90 mm Hg
- •Reports of sensitivity, allergy, or contraindication to opioids
- •Non-drug abusers:
- •Current or lifetime history of substance abuse or dependence according to DSM-IV criteria (those requiring detoxification)
- •Consumes more than 500 mg caffeine daily
- •Seeking treatment for substance use
研究组 & 干预措施
Rx Opioid Abusers
Recreational users of prescription opioids. Participants in this arm received the 3 interventions (0, 15, and 30 mg oxycodone) at random.
干预措施: oxycodone 15 mg (Drug)
Rx Opioid Abusers
Recreational users of prescription opioids. Participants in this arm received the 3 interventions (0, 15, and 30 mg oxycodone) at random.
干预措施: oxycodone 30 mg (Drug)
Rx Opioid Abusers
Recreational users of prescription opioids. Participants in this arm received the 3 interventions (0, 15, and 30 mg oxycodone) at random.
干预措施: Placebo 0 mg (Drug)
Rx Opioid Non-Abusers
Participants with a history of prescription opioid use, but who did not abuse them. Participants in this arm received the 3 interventions (0, 15, and 30 mg) at random.
干预措施: oxycodone 15 mg (Drug)
Rx Opioid Non-Abusers
Participants with a history of prescription opioid use, but who did not abuse them. Participants in this arm received the 3 interventions (0, 15, and 30 mg) at random.
干预措施: oxycodone 30 mg (Drug)
Rx Opioid Non-Abusers
Participants with a history of prescription opioid use, but who did not abuse them. Participants in this arm received the 3 interventions (0, 15, and 30 mg) at random.
干预措施: Placebo 0 mg (Drug)
结局指标
主要结局
Breakpoint
时间窗: Measured at 0, 60, 120, 180 and 240 minutes following administration of each oral oxycodone dose (0 , 15, 30 mg). Results presented as mean of the session
Maximum number of finger presses on a computer mouse completed. The "Breakpoint" is the amount of work (clicks on a mouse) participants were willing to do in order to received the dose of drug under investigation. This is a commonly used indicator of a drugs value and abuse liability.
次要结局
- Drug Liking(Highest rating obtained following adminstration of each of the 3 test doses.)