Reducing the Abuse Liability of Prescription Opioids
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Evaluation of analgesic efficacy- Cold pressor
研究概览
简要总结
Opioid (commonly called narcotic) pain medicines are, after marijuana, the most commonly abused substances in the United States. Patients who take opioids for legitimate reasons may become addicted; for example, as many as 1 in 4 patients meet the criteria for current opioid dependence. It is very important that a way is found to provide pain relief while minimizing the addiction potential of these widely used pain medications.
The study aim to find out if the use of another type of medication given in addition to an opioid will reduce the addiction potential of the opioid.
The study is trying to find out if the ability of the opioid to relieve pain is changed when given with the other medication, and to see if the euphoric sensation or "liking" of the opioid pain medication is reduced when taken with the other medication.
详细描述
This study involves the use of an investigational combination of drugs. "Oxycodone with Risperidone" and "Oxycodone with Ziprasidone" are called "Investigational" because the U.S. Food & Drug Administration (FDA) has not approved these drug combinations for the purpose of this study. Individually, each of these drugs is approved by the FDA for other reasons (i.e. oxycodone as a painkiller, while risperidone and ziprasidone are approved as anti-psychotic medications), but the administration of these drugs together has not been studied before or been approved by the FDA for this purpose.
This is the first study involving humans to examine the safety of this combination of drugs and how they work together. The goal of the study is to find out what effects, good and/or bad, it has on people who take them. Because the combination has not been studied in humans before, information about the safety and effectiveness is incomplete and all of the side effects are not yet known.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Subjects will be administered one of two fixed dose drug combinations. The control will be oxycodone plus placebo, whereas the treatment groups will receive oxycodone plus one of the two atypical antipsychotics (Risperidone, Ziprasidone) under study. Study drug will be compounded by outside research pharmacy.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Requirement of prior exposure to opioids
排除标准
- •Presence of psychiatric comorbidity
- •Presence of chronic pain disorder
- •Presence or history of substance use disorder
- •Current analgesic or neuroleptic medication usage (any medication for pain, including over-the-counter analgesics like ibuprofen/acetaminophen)
- •Pregnancy
- •Positive drug urine test
- •Continuous opioid misuse measure score of < 9
- •Presence or history of diabetes
- •Presence or history of cardiac disease or arrhythmia
研究组 & 干预措施
Oxycodone
This arm will be considered the control arm, containing oxycodone as the placebo.
干预措施: Oxycodone (Drug)
Oxycodone and Risperidone
Administration of oxycodone plus risperidone in a single capsule
干预措施: Risperidone (Drug)
Oxycodone and Risperidone
Administration of oxycodone plus risperidone in a single capsule
干预措施: Oxycodone (Drug)
Oxycodone and Ziprasidone
Administration of oxycodone and risperidone in a single capsule
干预措施: Ziprasidone (Drug)
Oxycodone and Ziprasidone
Administration of oxycodone and risperidone in a single capsule
干预措施: Oxycodone (Drug)
结局指标
主要结局
Evaluation of analgesic efficacy- Cold pressor
时间窗: two weeks
Perform quantitative evaluations of the analgesic efficacy of a novel fixed dose combination (FDC) of an opioid (oxycodone) in combination with one of two atypical antipsychotic drugs (either risperidone or ziprasidone) compared to the opioid alone. Analgesic efficacy will be measured with the cold pressor task which measures thermal pain. The cold pressor task measures the time the participant can tolerate their hand being submerged in the cold water up to a maximum of 5 minutes.
次要结局
- Evaluation of analgesic efficacy- Thumb pressor(two weeks)
- Drug liking(two weeks)
- Addiction Research Center Inventory test questionnaire(two weeks)
- Profile of Mood States test questionnaire(two weeks)
研究者
Max Eckmann
Associate Professor
The University of Texas Health Science Center at San Antonio