Opioid/Benzodiazepine Polydrug Abuse

Polysubstance Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03696017
• Other study ID #: Polydrug Aim 2
• Status: Recruiting
• Start date: February 8, 2019
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Wayne State University
• Contact: Heidi Aguas
• Phone: 3139933960
• Email: gh7962[@]wayne.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Polysubstance Abuse

Locations

Country	Name	City	State
United States	Tolan Park Medical Building	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychopathology	Semi-Structured Clinical Interview for DSM (Face-to-face interview) Evaluates lifetime and current psychiatric and substance use disorders.	Administered once during the baseline clinical assessment.
Primary	Beck Depression Inventory-II	Questionnaire measure of current depression symptoms	Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
Primary	Snaith-Hamilton Pleasure Scale	Questionnaire 14-item scale that measures anhedonia, the inability to experience pleasure. The items cover the domains of: social interaction, food and drink, sensory experience, and interest/pastimes. A score of 2 or less constitutes a "normal" score, while an "abnormal" score is defined as 3 or more. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. Either of the "disagree" responses score one point, and either of the "agree" responses score 0 points.	Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
Primary	Perceived Stress Scale	Questionnaire that measures the degree to which situations in one's life are appraised as stressful. Items were designed to assess how unpredictable, uncontrollable, and overloaded respondents find their lives to be. The scale also includes a number of direct queries about current levels of experienced stress.	Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
Primary	State-Trait Anxiety Inventory	Questionnaire that differentiates state anxiety from chronic trait anxiety symptoms.	Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
Primary	Difficulties with Emotion Regulation Scale	36-item questionnaire measure of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation. measures 6 empirically valid constructs related to emotion dysregulation: Non-acceptance of emotional responses, Difficulties in engaging in goal-directed behavior, Impulse control difficulties, Lack of emotional awareness, Limited access to emotion regulation strategies, and Lack of emotional clarity.	Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
Primary	Alcohol and Drug Use Self-Efficacy Scale	Questionnaire assesses self-efficacy and responses to high-risk situations that can trigger substance use.Items are grouped into negative affect, social positive withdrawal/urges, and physical/other concerns; subjects indicate how "tempted" and "confident" they would be in each situation.	Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
Primary	Distress Tolerance Scale	Questionnaire measure of emotional distress tolerance	Administered once during the clinical assessment.
Primary	Positive and Negative Affect Schedule-Short Form: Positive Affect	Questionnaire: 10-item measure of Positive Affect	Administered once during the baseline clinical assessment.
Primary	Positive and Negative Affect Schedule-Short Form: Negative Affect	Questionnaire: 10-item measure of Negative Affect	Administered once during the baseline clinical assessment.
Primary	Paced Auditory Serial Addition Task	mental arithmetic task with 3 trial blocks of increasing difficulty. Subjects can escape the task during block 3; latency (sec) to task termination is a primary outcome.	Administered once during the baseline clinical assessment.
Primary	Brief Pain Inventory-Short Form	Questionnaire measures pain severity (0=no pain; 10=pain as bad as you can imagine) and its functional impact (0=no interference; 10= interferes completely).	Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
Primary	Current Opioid Misuse Measure	Questionnaire measures risk of opioid misuse	Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
Primary	Insomnia Severity Index	Questionnaire asks about problem severity of sleep-onset, sleep-maintenance, early morning awakening, sleep satisfaction, interference with daily function, perceived impairment, and level of distress from insomnia. It has good internal consistency and concurrent validity (with polysomnography, sleep diaries, and clinician or significant-other reports), making it a valid and reliable measure of perceived sleep disturbance.	Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
Primary	Epworth Sleepiness Scale	Questionnaire measures 'sleep propensity', i.e. recent likelihood of dozing or falling asleep (rather than just feeling tired) in several situations.	Administered once during the baseline clinical assessment.
Primary	Psychomotor Vigilance Task	computerized, adaptive task (reaction time to a visual stimulus presented at random inter-trial intervals [ITI]) that will be used to assess attentional lapses; this objective, validated measure of sleepiness.	Administered once during the baseline clinical assessment.
Primary	Go/No-Go Task	Immediate and Delayed Memory Task assesses response inhibition. Participants are told to press a button to respond to stimulus X or Y presented in an alternating pattern (Go) and to withhold responding when the pattern is broken (No-Go). We will use percentage of correctly inhibited responses for each presentation.	Administered once during the baseline clinical assessment.
Primary	California Verbal Learning Test-Revised	Immediate and delayed memory will be assessed.	Administered once during the baseline clinical assessment.
Primary	Emotional Stroop Task	reaction time assessment of attentional bias for both emotion-related words	Administered once during the baseline clinical assessment.
Primary	Wisconsin Card Sort Test	number of items correct, measuring ability to shift or maintain cognitive set	Administered once during the baseline clinical assessment.
Primary	Digit Symbol Substitution Test	Psychomotor processing speed and associative ability will be assessed.	Administered once during the baseline clinical assessment.
Primary	Drug History Questionnaire	assesses lifetime substance use (e.g. age of initial and regular use, sequence of use of opioids and BZDs, adverse consequences of use, quit attempts.	Administered once during the baseline clinical assessment.
Primary	Timeline Followback interview	Assesses all substance use over the past 30 days; this will generate detailed data on patterns of opioid, BZD and alcohol use (e.g. simultaneous vs. concurrent, including customized queries to determine whether using one drug primes use of another, under what affective conditions (positive, neutral, negative) substances are used together, and number of days since last use (which could influence affective, neurocognitive or behavioral measures).	Administered during the baseline clinical assessment, and at the 3-month follow-up visit
Primary	Opioid /Benzodiazepine Purchasing Task	Hypothetical purchasing tasks (economic simulations) will assess drug demand. will be tailored to each subject's preferred opioid (e.g. heroin, oxycodone, hydrocodone) or benzodiazepine based on screening self-report.	Administered once during the baseline clinical assessment.
Primary	Urinalysis	One urine sample will be collected and tested for opioids, methadone, cocaine, amphetamines, barbiturates, and cannabinoids using a 6-panel CLIA waived drug test. The urine sample will be collected into multi-test cups with temperature strips (CLIA Waived; temperature must be 92-96º F). Samples will be tested for opioids, methadone, cocaine, amphetamines, barbiturates (negative cutoff <300 ng/ml), and cannabinoids (negative cutoff < 50ng/ml).	At baseline clinical assessment, and at the 3-month follow-up visit