Clinical trial NCT03696017: Opioid/benzodiazepine Polydrug Abuse
Official title: Opioid/benzodiazepine Polydrug Abuse: Integrating Research on Mechanisms, Treatment and Policies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polysubstance Abuse
Keywords: Opioid Abuse
Benzodiazepine abuse
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will either be newly admitted to Substance Use Disorder treatment, or in treatment longer but still occasionally using substances.

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: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Psychopathology
timeFrame: Administered once during the baseline clinical assessment.
measure: Beck Depression Inventory-II
timeFrame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
measure: Snaith-Hamilton Pleasure Scale
timeFrame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
measure: Perceived Stress Scale
timeFrame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
measure: State-Trait Anxiety Inventory
timeFrame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
measure: Difficulties with Emotion Regulation Scale
timeFrame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
measure: Alcohol and Drug Use Self-Efficacy Scale
timeFrame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
measure: Distress Tolerance Scale
timeFrame: Administered once during the clinical assessment.
measure: Positive and Negative Affect Schedule-Short Form: Positive Affect
timeFrame: Administered once during the baseline clinical assessment.
measure: Positive and Negative Affect Schedule-Short Form: Negative Affect
timeFrame: Administered once during the baseline clinical assessment.
measure: Paced Auditory Serial Addition Task
timeFrame: Administered once during the baseline clinical assessment.
measure: Brief Pain Inventory-Short Form
timeFrame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
measure: Current Opioid Misuse Measure
timeFrame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
measure: Insomnia Severity Index
timeFrame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
measure: Epworth Sleepiness Scale
timeFrame: Administered once during the baseline clinical assessment.
measure: Psychomotor Vigilance Task
timeFrame: Administered once during the baseline clinical assessment.
measure: Go/No-Go Task
timeFrame: Administered once during the baseline clinical assessment.
measure: California Verbal Learning Test-Revised
timeFrame: Administered once during the baseline clinical assessment.
measure: Emotional Stroop Task
timeFrame: Administered once during the baseline clinical assessment.
measure: Wisconsin Card Sort Test
timeFrame: Administered once during the baseline clinical assessment.
measure: Digit Symbol Substitution Test
timeFrame: Administered once during the baseline clinical assessment.
measure: Drug History Questionnaire
timeFrame: Administered once during the baseline clinical assessment.
measure: Timeline Followback interview
timeFrame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit
measure: Opioid /Benzodiazepine Purchasing Task
timeFrame: Administered once during the baseline clinical assessment.
measure: Urinalysis
timeFrame: At baseline clinical assessment, and at the 3-month follow-up visit
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Tolan Park Medical Building
state: Michigan
Study officials:
affiliation: Wayne State University
name: Mark Greenwald, PhD
role: PRINCIPAL_INVESTIGATOR
References: