Polysubstance AbuseNCT03696017
Opioid/Benzodiazepine Polydrug Abuse
An observational study of Polysubstance Abuse, run by Wayne State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Polysubstance Abuse
- What is being tested?
- Multi-domain assessment battery
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2019to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will either be newly admitted to Substance Use Disorder treatment, or in treatment longer but still occasionally using substances.
Who may be able to join
- Recently admitted and/or not clinically stable in treatment for Substance Use Disorder (SUD) in Wayne County
- Using opioids, benzodiazepines (BZD), or BZD/opioid.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Tolan Park Medical Building
Detroit, Michigan, 48201
Heidi Aguas, 313-993-3960, gh7962@wayne.edu
About this study
Official title: Opioid/Benzodiazepine Polydrug Abuse: Integrating Research on Mechanisms, Treatment and Policies
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.
Read more
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.
Read the 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.
- Conditions
- Polysubstance Abuse
- Being tested
- Multi-domain assessment battery
- Keywords
- Opioid Abuse, Benzodiazepine abuse
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-domain assessment batteryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Multi-domain assessment battery | |
| 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). Receives: Other: Multi-domain assessment battery | |
| 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). Receives: Other: Multi-domain assessment battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychopathology
Semi-Structured Clinical Interview for DSM (Face-to-face interview) Evaluates lifetime and current psychiatric and substance use disorders.
Measured: Administered once during the baseline clinical assessment.
Beck Depression Inventory-II
Questionnaire measure of current depression symptoms
Measured: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
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.
Measured: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
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.
Measured: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
State-Trait Anxiety Inventory
Questionnaire that differentiates state anxiety from chronic trait anxiety symptoms.
Measured: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
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.
Measured: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
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.
Measured: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
Distress Tolerance Scale
Questionnaire measure of emotional distress tolerance
Measured: Administered once during the clinical assessment.
Positive and Negative Affect Schedule-Short Form: Positive Affect
Questionnaire: 10-item measure of Positive Affect
Measured: Administered once during the baseline clinical assessment.
Positive and Negative Affect Schedule-Short Form: Negative Affect
Questionnaire: 10-item measure of Negative Affect
Measured: Administered once during the baseline clinical assessment.
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.
Measured: Administered once during the baseline clinical assessment.
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).
Measured: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
Current Opioid Misuse Measure
Questionnaire measures risk of opioid misuse
Measured: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
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.
Measured: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
Epworth Sleepiness Scale
Questionnaire measures 'sleep propensity', i.e. recent likelihood of dozing or falling asleep (rather than just feeling tired) in several situations.
Measured: Administered once during the baseline clinical assessment.
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.
Measured: Administered once during the baseline clinical assessment.
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.
Measured: Administered once during the baseline clinical assessment.
California Verbal Learning Test-Revised
Immediate and delayed memory will be assessed.
Measured: Administered once during the baseline clinical assessment.
Emotional Stroop Task
reaction time assessment of attentional bias for both emotion-related words
Measured: Administered once during the baseline clinical assessment.
Wisconsin Card Sort Test
number of items correct, measuring ability to shift or maintain cognitive set
Measured: Administered once during the baseline clinical assessment.
Digit Symbol Substitution Test
Psychomotor processing speed and associative ability will be assessed.
Measured: Administered once during the baseline clinical assessment.
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.
Measured: Administered once during the baseline clinical assessment.
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).
Measured: Administered during the baseline clinical assessment, and at the 3-month follow-up visit
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.
Measured: Administered once during the baseline clinical assessment.
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).
Measured: At baseline clinical assessment, and at the 3-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start8 Feb 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polysubstance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Greenwald, PhD, Wayne State University
- Investigators
- Mark Greenwald, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696017
- Sponsor's protocol ID
- Polydrug Aim 2
- Status last verified
- Dec 2025
- First submitted
- 26 Sep 2018
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36741122
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid/Benzodiazepine Polydrug Abuse: Integrating Research on Mechanisms, Treatment and Policies
- ClinicalTrials.gov ID
- NCT03696017
- Acronym / sponsor ID
- Polydrug Aim 2
- Conditions
- Polysubstance Abuse
- Keywords
- Opioid Abuse, Benzodiazepine abuse
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Multi-domain assessment batteryPatients 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 | – | Other: Multi-domain assessment batteryPatients 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 | – | Other: Multi-domain assessment batteryPatients either newly admitted to Substance Use Disorder treatment in Wayne County, or in treatment longer but are using BZD/opioid (40 patients per group). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will either be newly admitted to Substance Use Disorder treatment, or in treatment longer but still occasionally using substances.
Key inclusion criteria (2 listed)
- Recently admitted and/or not clinically stable in treatment for Substance Use Disorder (SUD) in Wayne County
- Using opioids, benzodiazepines (BZD), or BZD/opioid.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-domain assessment batteryAssessments 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. | Other | Group 1, Group 2, Group 3 |
Primary outcome
Psychopathology
Time frame: Administered once during the baseline clinical assessment.
Semi-Structured Clinical Interview for DSM (Face-to-face interview) Evaluates lifetime and current psychiatric and substance use disorders.
Beck Depression Inventory-II
Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
Questionnaire measure of current depression symptoms
Snaith-Hamilton Pleasure Scale
Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
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.
Perceived Stress Scale
Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
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.
State-Trait Anxiety Inventory
Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
Questionnaire that differentiates state anxiety from chronic trait anxiety symptoms.
Difficulties with Emotion Regulation Scale
Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
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.
Alcohol and Drug Use Self-Efficacy Scale
Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
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.
Distress Tolerance Scale
Time frame: Administered once during the clinical assessment.
Questionnaire measure of emotional distress tolerance
Positive and Negative Affect Schedule-Short Form: Positive Affect
Time frame: Administered once during the baseline clinical assessment.
Questionnaire: 10-item measure of Positive Affect
Positive and Negative Affect Schedule-Short Form: Negative Affect
Time frame: Administered once during the baseline clinical assessment.
Questionnaire: 10-item measure of Negative Affect
Paced Auditory Serial Addition Task
Time frame: Administered once during the baseline clinical assessment.
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.
Brief Pain Inventory-Short Form
Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
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).
Current Opioid Misuse Measure
Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
Questionnaire measures risk of opioid misuse
Insomnia Severity Index
Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit.
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.
Epworth Sleepiness Scale
Time frame: Administered once during the baseline clinical assessment.
Questionnaire measures 'sleep propensity', i.e. recent likelihood of dozing or falling asleep (rather than just feeling tired) in several situations.
Psychomotor Vigilance Task
Time frame: Administered once during the baseline clinical assessment.
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.
Go/No-Go Task
Time frame: Administered once during the baseline clinical assessment.
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.
California Verbal Learning Test-Revised
Time frame: Administered once during the baseline clinical assessment.
Immediate and delayed memory will be assessed.
Emotional Stroop Task
Time frame: Administered once during the baseline clinical assessment.
reaction time assessment of attentional bias for both emotion-related words
Wisconsin Card Sort Test
Time frame: Administered once during the baseline clinical assessment.
number of items correct, measuring ability to shift or maintain cognitive set
Digit Symbol Substitution Test
Time frame: Administered once during the baseline clinical assessment.
Psychomotor processing speed and associative ability will be assessed.
Drug History Questionnaire
Time frame: Administered once during the baseline clinical assessment.
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.
Timeline Followback interview
Time frame: Administered during the baseline clinical assessment, and at the 3-month follow-up visit
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).
Opioid /Benzodiazepine Purchasing Task
Time frame: Administered once during the baseline clinical assessment.
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.
Urinalysis
Time frame: At baseline clinical assessment, and at the 3-month follow-up visit
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Derived from this study: PubMed 36741122Greenwald 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Greenwald, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polysubstance Abuse, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidi Aguas (3139933960, gh7962@wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychopathology (time frame: Administered once during the baseline clinical assessment.). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03696017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.