Opioid/Benzodiazepine Polydrug Abuse
Sponsor:
Wayne State University
Collaborators:
Information provided by (Responsible Party):
Mark Greenwald, PhD，Wayne State University
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date ICMJE | September 26, 2018 | ||
| First Posted Date ICMJE | October 4, 2018 | ||
| Last Update Posted Date | October 4, 2018 | ||
| Actual Study Start Date ICMJE | September 30, 2018 | ||
| Estimated Primary Completion Date | September 30, 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures 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. |
||
| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
|
||
| Descriptive Information | |||
| Brief Title ICMJE | Opioid/Benzodiazepine Polydrug Abuse |
||
| Official Title ICMJE | Opioid/Benzodiazepine Polydrug Abuse: Integrating Research on Mechanisms, Treatment and Policies |
||
| Brief Summary | 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. |
||
| Detailed Description | 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. | ||
| Study Type ICMJE | Observational | ||
| Study Phase | |||
| Study Design ICMJE | Allocation: Intervention Model: Intervention Model Description: Masking: Observational Masking Description: Primary Purpose: |
||
| Condition ICMJE | |||
| Intervention ICMJE |
|
||
| Study Arms |
|
||
| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
120 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | September 30, 2019 | ||
| Estimated Primary Completion Date | September 30, 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria 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. | ||
| Sex/Gender |
|
||
| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | |||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
||
| IPD Sharing Statement |
|
||
| Responsible Party | Mark Greenwald, PhD，Wayne State University | ||
| Study Sponsor ICMJE | Wayne State University | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
|
||
| PRS Account | Wayne State University | ||
| Verification Date | October 2018 | ||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||
请使用微信扫码报名
京公网安备 11010102003638号