Opioid/Benzodiazepine Polydrug Abuse

Официальное название

Opioid/Benzodiazepine Polydrug Abuse: Integrating Research on Mechanisms, Treatment and Policies

Обзор

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.

Подробное описание

Up to 120 patients who are currently in Substance Use Disorder treatment in Wayne County who use opioids, benzodiazepines (BZD), or both, will be assessed. Patients will be referred from the treatment regulator and local providers, and by advertisements in the community.

Participants will take part in one 6 hour face-to-face assessment 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.

Psychopathology: The Semi-Structured Clinical Interview for DSM-5 will be used to evaluate lifetime and current psychiatric and substance use disorders.

Affective dysregulation (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: Up to 120 total participant 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.

Вмешательства

• Другое Multi-domain assessment battery
  Assessments of emotion regulation, neurocognitive performance, pain, sleep, and substance use. There is no therapeutic intervention; all participants are already independently in treatment for their substance use disorder and we are simply assessing them at baseline visit and 3-month follow-up.

Первичные конечные точки

• Psychopathology [Срок оценки: Administered once during the baseline clinical assessment.]
• Beck Depression Inventory-II [Срок оценки: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.]
• Snaith-Hamilton Pleasure Scale [Срок оценки: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.]
• Perceived Stress Scale [Срок оценки: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.]
• State-Trait Anxiety Inventory [Срок оценки: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.]
• Difficulties with Emotion Regulation Scale [Срок оценки: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.]
• Alcohol and Drug Use Self-Efficacy Scale [Срок оценки: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.]
• Distress Tolerance Scale [Срок оценки: Administered once during the clinical assessment.]
• Positive and Negative Affect Schedule-Short Form: Positive Affect [Срок оценки: Administered once during the baseline clinical assessment.]
• Positive and Negative Affect Schedule-Short Form: Negative Affect [Срок оценки: Administered once during the baseline clinical assessment.]

Критерии участия

Критерии включения

• Recently admitted and/or not clinically stable in treatment for Substance Use Disorder (SUD) in Wayne County
• Using opioids, benzodiazepines (BZD), or BZD/opioid.

Критерии исключения

• Participants with current psychosis, bipolar disorder, or severe depression (i.e. severe psychiatric disorder)
• Individuals with serious neurological disorders, e.g. brain tumor, history of stroke, history of traumatic brain injury w/ loss of consciousness
• Cognitive impairment (IQ<80)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 1 центр

• Tolan Park Medical Building — Detroit

Публикации

• Greenwald MK, Moses TEH, Lundahl LH, Roehrs TA. Anhedonia modulates benzodiazepine and opioid demand among persons in treatment for opioid use disorder. Front Psychiatry. 2023 Jan 19;14:1103739. doi: 10.3389/fpsyt.2023.1103739. eCollection 2023. PMID 36741122

Идентификаторы

NCT: NCT03696017 · Polydrug Aim 2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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