Recruiting

Polydrug Abuse

Sponsor:

Wayne State University

Code:

NCT03696017

Conditions

Polysubstance Abuse

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Multi-domain assessment battery

Study Details

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.

Conditions

Polysubstance Abuse

Study ID

NCT03696017

Start date

Feb 8, 2019

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

Patients either newly admitted to Substance Use Disorder treatment in Wayne County, or in treatment longer but are using opioids (40 patients per group).

Group 2

Patients either newly admitted to Substance Use Disorder treatment in Wayne County, or in treatment longer but are using benzodiazepines (BZD) (40 patients per group).

Group 3

Patients either newly admitted to Substance Use Disorder treatment in Wayne County, or in treatment longer but are using BZD/opioid (40 patients per group).

Interventions

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.

Primary outcome measure

  • Psychopathology [ Time Frame: Administered once during the baseline clinical assessment. ]
  • Beck Depression Inventory-II [ Time Frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit. ]
  • Snaith-Hamilton Pleasure Scale [ Time Frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit. ]
  • Perceived Stress Scale [ Time Frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit. ]
  • State-Trait Anxiety Inventory [ Time Frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit. ]
  • Difficulties with Emotion Regulation Scale [ Time Frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit. ]
  • Alcohol and Drug Use Self-Efficacy Scale [ Time Frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit. ]
  • Distress Tolerance Scale [ Time Frame: Administered once during the clinical assessment. ]
  • Positive and Negative Affect Schedule-Short Form: Positive Affect [ Time Frame: Administered once during the baseline clinical assessment. ]
  • Positive and Negative Affect Schedule-Short Form: Negative Affect [ Time Frame: Administered once during the baseline clinical assessment. ]
  • Paced Auditory Serial Addition Task [ Time Frame: Administered once during the baseline clinical assessment. ]
  • Brief Pain Inventory-Short Form [ Time Frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit. ]
  • Current Opioid Misuse Measure [ Time Frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit. ]
  • Insomnia Severity Index [ Time Frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit. ]
  • Epworth Sleepiness Scale [ Time Frame: Administered once during the baseline clinical assessment. ]
  • Psychomotor Vigilance Task [ Time Frame: Administered once during the baseline clinical assessment. ]
  • Go/No-Go Task [ Time Frame: Administered once during the baseline clinical assessment. ]
  • California Verbal Learning Test-Revised [ Time Frame: Administered once during the baseline clinical assessment. ]
  • Emotional Stroop Task [ Time Frame: Administered once during the baseline clinical assessment. ]
  • Wisconsin Card Sort Test [ Time Frame: Administered once during the baseline clinical assessment. ]
  • Digit Symbol Substitution Test [ Time Frame: Administered once during the baseline clinical assessment. ]
  • Drug History Questionnaire [ Time Frame: Administered once during the baseline clinical assessment. ]
  • Timeline Followback interview [ Time Frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit ]
  • Opioid /Benzodiazepine Purchasing Task [ Time Frame: Administered once during the baseline clinical assessment. ]
  • Urinalysis [ Time Frame: At baseline clinical assessment, and at the 3-month follow-up visit ]

Central Contacts and Locations

Central contacts

Heidi Aguas

3139933960gh7962@wayne.edu

Locations

Tolan Park Medical Building

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Heidi Aguas

313-993-3960gh7962@wayne.edu

More Information

Sponsor

Wayne State University

Last update posted

Dec 30, 2025

Last verified

Dec, 2025

Keywords

  • Opioid Abuse
  • Benzodiazepine abuse

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wayne State University on 2025-12-30.