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Opioid/Benzodiazepine Polydrug Abuse

NCT03696017, Recruiting, Wayne State University

Trial 9

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

FieldValueSource
TitleOpioid/Benzodiazepine Polydrug AbuseClinicalTrials.gov
NCT numberNCT03696017ClinicalTrials.gov
StatusRecruitingClinicalTrials.gov
Enrollment120 participants, estimatedClinicalTrials.gov
Lead sponsorWayne State UniversityClinicalTrials.gov
ConditionsPolysubstance AbuseClinicalTrials.gov
InterventionsMulti-domain assessment batteryClinicalTrials.gov
First posted2018-10-04ClinicalTrials.gov
Last updated2025-12-30ClinicalTrials.gov

Registered outcomes 25

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescriptionSource
PrimaryPsychopathologyAdministered 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.ClinicalTrials.gov
PrimaryBeck Depression Inventory-IIAdministered during the baseline clinical assessment, and at the 3-month follow-up visit.Questionnaire measure of current depression symptomsClinicalTrials.gov
PrimarySnaith-Hamilton Pleasure ScaleAdministered 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.
ClinicalTrials.gov
PrimaryPerceived Stress ScaleAdministered 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.
ClinicalTrials.gov
PrimaryState-Trait Anxiety InventoryAdministered during the baseline clinical assessment, and at the 3-month follow-up visit.Questionnaire that differentiates state anxiety from chronic trait anxiety symptoms.ClinicalTrials.gov
PrimaryDifficulties with Emotion Regulation ScaleAdministered 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.
ClinicalTrials.gov
PrimaryAlcohol and Drug Use Self-Efficacy ScaleAdministered 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.
ClinicalTrials.gov
PrimaryDistress Tolerance ScaleAdministered once during the clinical assessment.Questionnaire measure of emotional distress toleranceClinicalTrials.gov
PrimaryPositive and Negative Affect Schedule-Short Form: Positive AffectAdministered once during the baseline clinical assessment.Questionnaire: 10-item measure of Positive AffectClinicalTrials.gov
PrimaryPositive and Negative Affect Schedule-Short Form: Negative AffectAdministered once during the baseline clinical assessment.Questionnaire: 10-item measure of Negative AffectClinicalTrials.gov
PrimaryPaced Auditory Serial Addition TaskAdministered 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.ClinicalTrials.gov
PrimaryBrief Pain Inventory-Short FormAdministered 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).ClinicalTrials.gov
PrimaryCurrent Opioid Misuse MeasureAdministered during the baseline clinical assessment, and at the 3-month follow-up visit.Questionnaire measures risk of opioid misuseClinicalTrials.gov
PrimaryInsomnia Severity IndexAdministered 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.
ClinicalTrials.gov
PrimaryEpworth Sleepiness ScaleAdministered 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.ClinicalTrials.gov
PrimaryPsychomotor Vigilance TaskAdministered 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.
ClinicalTrials.gov
PrimaryGo/No-Go TaskAdministered 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.
ClinicalTrials.gov
PrimaryCalifornia Verbal Learning Test-RevisedAdministered once during the baseline clinical assessment.Immediate and delayed memory will be assessed.ClinicalTrials.gov
PrimaryEmotional Stroop TaskAdministered once during the baseline clinical assessment.reaction time assessment of attentional bias for both emotion-related wordsClinicalTrials.gov
PrimaryWisconsin Card Sort TestAdministered once during the baseline clinical assessment.number of items correct, measuring ability to shift or maintain cognitive setClinicalTrials.gov

Outcomes 0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured asSource

Results by group 0

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnitsSource

Participant flow 0

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits countedSource

Adverse events 0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEventsSource

Adverse event totals 0

The totals the trial posted for each group.

TotalGroupAffectedAt riskSource

Papers 1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
36741122DERIVEDPubMed

Grants 0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal yearsSource

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource

Tests 9

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource
Arithmetic Fluency TaskPrimary outcomeConductCognition
Emotional Stroop TaskPrimary outcomeConductCognition
Go/No-Go TaskPrimary outcomeConductCognition
Immediate and Delayed Memory TaskPrimary outcomeConductCognition
Paced Visual Serial Addition TestPrimary outcomeConductCognition
Psychomotor Vigilance TaskPrimary outcomeConductCognition
Stroop Color-Word TestPrimary outcomeConductCognition
Symbol CodingPrimary outcomeConductCognition
Verbal LearningPrimary outcomeConductCognition

Source 5

FieldValueSource
Releasetrials-2026-11-12-0.4.0ClinicalTrials.gov
Release manifest SHA-2560f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4ClinicalTrials.gov
Registry capture2026-11-12ClinicalTrials.gov
Results copy, AACT2026-03-23ClinicalTrials.gov
NIH clinical studies file2026-11-13ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)