Opioid/Benzodiazepine Polydrug Abuse
赞助:
Wayne State University
合作者:
信息的提供 (责任方):
Mark Greenwald, PhD，Wayne State University
| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 26, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | September 30, 2018 | ||
| 预计主要完成日期 | September 30, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Psychopathology[ Time Frame: Administered once during the 3.5 hour clinical assessment. ] Semi-Structured Clinical Interview for DSM evaluate lifetime and current psychiatric and substance use disorders. Psychopathology[ Time Frame: Administered once during the 3.5 hour clinical assessment. ] Addiction Severity Index to evaluate the severity of problems in medical, employment, drug, alcohol, legal, family/social, and psychological domains. Affective Disregulation[ Time Frame: Administered once during the 3.5 hour clinical assessment. ] Beck Depression Inventory-II Affective Disregulation[ Time Frame: Administered once during the 3.5 hour clinical assessment. ] Snaith-Hamilton Pleasure Scale Affective Disregulation[ Time Frame: Administered once during the 3.5 hour clinical assessment. ] Perceived Stress Scale Affective Disregulation[ Time Frame: Administered once during the 3.5 hour clinical assessment. ] State-Trait Anxiety Inventory Affective Disregulation[ Time Frame: Administered once during the 3.5 hour clinical assessment. ] Difficulties with Emotion Regulation Scale Affective Disregulation[ Time Frame: Administered once during the 3.5 hour clinical assessment. ] Alcohol and Drug Use Self-Efficacy Scale Affective Disregulation[ Time Frame: Administered once during the 3.5 hour clinical assessment. ] Distress Tolerance Scale Affective Disregulatio[ Time Frame: Administered once during the 3.5 hour clinical assessment. ] Positive and Negative Affect Schedule-Short Form. Affective Disregulation[ Time Frame: Administered once during the 3.5 hour clinical assessment. ] Paced Auditory Serial Addition Task Behavior: Pain and Prescription Misuse[ Time Frame: Each instrument will be administered once during the 3.5 hour clinical assessment. ] Brief Pain Inventory-Short Form, Current Opioid Misuse Measure Behavior: Insomnia[ Time Frame: Administered once during the 3.5 hour clinical assessment. ] Insomnia Severity Index Behavior: Sleepiness[ Time Frame: Administered once during the 3.5 hour clinical assessment. ] Epworth Sleepiness Scale Behavior: Vigilance[ Time Frame: Administered once during the 3.5 hour clinical assessment. ] Psychomotor Vigilance Task Neurocognition[ Time Frame: Each neurocognitive test will be administered once during the 3.5 hour clinical assessment. ] Go/No-Go Task Immediate and Delayed Memory Task Neurocognition[ Time Frame: Each neurocognitive test will be administered once during the 3.5 hour clinical assessment. ] Hopkins Verbal Learning Test-Revised Neurocognition[ Time Frame: Each neurocognitive test will be administered once during the 3.5 hour clinical assessment. ] Addiction Stroop Task Neurocognition[ Time Frame: Each neurocognitive test will be administered once during the 3.5 hour clinical assessment. ] Wisconsin Card Sorting Test Neurocognition[ Time Frame: Each neurocognitive test will be administered once during the 3.5 hour clinical assessment. ] Digit Symbol Substitution Test Behavior: Substance use[ Time Frame: Administered once during the 3.5 hour clinical assessment. ] Drug History Questionnaire Behavior: Substance use[ Time Frame: Administered once during the 3.5 hour clinical assessment. ] Timeline Followback interview Behavior: Substance use[ Time Frame: Administered once during the 3.5 hour clinical assessment. ] Opioid /BZD Purchasing Task Biomarker of recent substance use[ Time Frame: Once during 3.5 hour clinical assessment. ] One urine sample will be collected and tested for opioids, methadone, cocaine, amphetamines, barbiturates, and cannabinoids using a 6-panel CLIA waived drug test. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Opioid/Benzodiazepine Polydrug Abuse | ||
| 正式标题 ICMJE | Opioid/Benzodiazepine Polydrug Abuse: Integrating Research on Mechanisms, Treatment and Policies | ||
| 简要概况 | Benzodiazepine (BZD)/opioid polysubstance abuse (PSA) dramatically increases risks of overdose, disability and death; however, little is known about phenotypes that could be targeted to decrease this use and these associated risks. The opioid abuse epidemic is generating unprecedented numbers of overdoses (OD) and deaths from prescribed and illegal sources (e.g. fentanyl combined with, or sold as, heroin). Yet, medical and epidemiological data suggest these adverse outcomes are not solely due to over-consumption of opioids.The FDA recognizes the health danger of BZD/opioid PSA, and issued labeling changes for prescribing BZDs and opioids. Impact of these changes is unclear and could be minimal if people obtain these substances illegally. BZD abuse can be harmful alone or combined with opioids, as BZDs: (a) contribute to OD/death e.g. 31% of opioid OD-related deaths from 1999 to 2011 were related to coincident BZD use, BZD co-use is dose-dependently related to mortality and rates of BZD OD deaths have sharply increased. (b) exacerbate progression and adverse outcomes of opioid abuse. and (c) worsen behavioral impairment from opioids, increase rates of falls and fractures, motor vehicle accidents, and sleep-disordered breathing. There has been limited systematic research of BZD/opioid PSA. This is a major gap because BZD are often co-prescribed with opioids (in 33 to 50% of cases) and are easily obtained illegally. In response to these problems, there is an urgent need to obtain population-level, clinical pharmacology, and mechanistic data to test our unified hypothesis of dual-deficit in affective/hedonic regulation. |
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| 详细说明 | A subset (n=120) of patients newly admitted to Substance Use Disorder treatment in Wayne County who abuse (Group 1) opioids, (Group 2) benzodiazepines (BZD), and (Group 3) BZD/opioid (40 patients per group) will be assessed. Patients will be referred from the treatment regulator and local providers prior to receiving any psychosocial treatment. Participants will take part in one 3.5 hour face-to-face assessment prior to entering treatment during which they will undergo comprehensive assessments of both clinical (substance use, mental health) and hypothesis-driven measures (affective, neurocognitive, behavioral). Participants must provide a supervised alcohol-free breath sample and a urine sample that will be screened for opioids, methadone, cocaine metabolites, BZDs, barbiturates, amphetamines. Data Collection: Psychopathology: The Semi-Structured Clinical Interview for DSM-5 will be used to evaluate lifetime and current psychiatric and substance use disorders, and the Addiction Severity Index to evaluate the severity of problems in medical, employment, drug, alcohol, legal, family/social, and psychological domains. Affective disregulation (inability to regulate emotions), neurocognition, pain and prescription misuse, insomnia, sleepiness, vigilance, and substance use will be assessed through the use of computerized measurements as well as paper and pencil questionnaires and face-to-face interviews. Sample Size: In Aim 2 40 patients in each of the 3 drug-use groups (n=120 total) will be evaluated. This will offer greater statistical power to detect affective and neurocognitive effects than prior studies, including analysis of sex differences and correction for multiple comparisons. | ||
| 研究类型 ICMJE | Observational | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 盲法描述: 主要目的: |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
120 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | September 30, 2019 | ||
| 预计主要完成日期 | September 30, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Newly admitted to Substance Use Disorder (SUD) treatment in Wayne County - Abusing opioids, benzodiazepines (BZD), or BZD/opioid. Exclusion Criteria: - Participants with current psychosis, bipolar disorder, or severe depression (i.e. severe psychiatric disorder). - Participants with Cocaine Use Disorder. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：55 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Mark Greenwald, PhD，Wayne State University | ||
| 研究赞助商 ICMJE | Wayne State University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Wayne State University | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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