Opioid Use Disorder
Conditions
Keywords
opioids, opioid use disorder, stress
Brief summary
The goal of this clinical trial is to develop a human laboratory model of resilience in people with opioid use disorder (OUD). The investigators aim to learn if objective tasks that measure cognitive, emotional, and control aspects of resilience match up with self-reported resilience during stress and non-stress situations.
Detailed description
This study is an outpatient, within-subject, randomized controlled trial designed to develop and validate a novel laboratory-based model for assessing resilience in individuals with opioid use disorder (OUD). The study employs a dual-condition design where participants complete two experimental sessions administered in a randomized order: one under a stress condition and one under a non-stress condition. In each session, participants will perform a series of standardized laboratory tasks aimed at evaluating cognitive, emotional, and control aspects of resilience. Objective measures (e.g., task performance data and physiological indices) and subjective ratings of stress reactivity will be collected to capture both behavioral and self-perceived responses. Additionally, this study includes an administrative supplement focused on Natural Language Processing (NLP) phenotyping. A subset of participants who complete the primary human laboratory resilience assessments will participate in a semi-structured qualitative interview probing personal definitions and experiences of resilience and spirituality. The resulting narratives will be analyzed using AI and NLP methods to derive quantitative linguistic indices. These indices will be integrated with the parent study's behavioral and physiological data to determine if narrative markers of spirituality and resilience improve the prediction of stress-induced opioid demand and refine mechanistic models of OUD.
Interventions
BEHAVIORALAcute Stress Intervention (MAST-based)
This intervention uses the Maastricht Acute Stress Test (MAST) to induce an acute stress response. Participants are exposed to standardized stress tasks while performing laboratory-based assessments of cognitive, emotional, and control aspects of resilience.
BEHAVIORALNon-Stress Intervention (NST-based)
In this control intervention, participants complete the same battery of laboratory tasks without exposure to the acute stressor.
Sponsors
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Can provide informed consent and can comply with study procedures 2. Adults aged ≥18 years 3. Meet Diagnostic and Statistical Manual (DSM-5) criteria for current opioid use disorder or are currently receiving pharmacotherapy for the treatment of OUD (e.g. methadone or buprenorphine maintenance treatment \[remission\]) 4. Urine sample that tests positive for opioids 5. Test negative for pregnancy at screening (females only)
Exclusion criteria
1. Being pregnant or breastfeeding 2. Significant mental health or physical disorder, or life circumstances, that is judged by the investigators to interfere with study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Trait Resilience as assessed by Connor-Davidson Resilience Scale 25 (CD-RISC-25) | Immediately after completing the task | Instrument: Connor-Davidson Resilience Scale 25 Score Range: 0-100 Interpretation: Higher scores indicate greater resilience. |
| Cognitive Flexibility: Stroop Color-Word Test reaction time | Immediately after completing the task | Instrument: Stroop Color-Word Test Unit: Milliseconds (ms) Interpretation: Higher values = slower performance (worse) |
| Emotional Flexibility: Emotional Stroop Task reaction time | Immediately after completing the task | Instrument: Emotional Stroop Task Unit: Milliseconds (ms) Interpretation: Higher values = slower performance (worse). |
| Perceived Controllability (Controllable) assessed by Social Controllability Task (SCT) | Immediately after completing the task | Instrument: Social Controllability Task Description: Participants ratings on a 0-100% sliding scale. Interpretation: Higher scores indicate greater perceived control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Effects of Stress as assessed by the Subjective Effects Visual Analog Scale (VAS) Battery | Immediately after completing the task | Instrument: Subjective Effects Visual Analog Scale (VAS) Battery Instrument: VAS (0-100 mm) Interpretation: Higher scores indicate greater intensity of each subjective state. |
| Heart Rate | Immediately after completing the task | Unit: Beats per minute (bpm) Interpretation: Higher = increased arousal |
| Systolic Blood Pressure | Immediately after completing the task | Unit: mmHg Interpretation: Higher = greater pressure. |
| Diastolic Blood Pressure | Immediately after completing the task | Unit: mmHg Interpretation: Higher = greater pressure. |
| Opioid Demand Breakpoint as assessed by the Hypothetical Purchase Task | Immediately after completing the task | Instrument: Hypothetical Purchase Task Range: $0-$500 Interpretation: Higher = greater demand. |
| Percentage of Resilience-themed Interview Content | Up to 1 year | This outcome is defined as the average percentage of narrative content within semi-structured qualitative interviews classified as "resilience-themed" using Latent Dirichlet Allocation (LDA). This measure quantifies the relative focus a participant places on adaptive coping and recovery narratives |
| Percentage of Spirituality-themed Interview Content | Up to 1 year | This outcome is defined as the average percentage of narrative content within semi-structured qualitative interviews classified as "spirituality-themed" using Latent Dirichlet Allocation (LDA). This measure quantifies the relative focus a participant places on spiritual or existential frameworks as a component of their recovery. |
| Mean Narrative Sentiment Valence Score | Up to 1 year | A quantitative emotional-tone score calculated from participant interview transcripts using a standardized sentiment analysis algorithm. The score range is -1 to +1. A score of -1 represents a highly negative emotional valence, while a score of +1 represents a highly positive emotional valence. Higher scores indicate a more positive emotional narrative. |
| Incremental Variance (∆R2) in Stress-Induced Opioid Demand Predicted by NLP Indices | From baseline up to 1 year | This outcome measures the change in R-squared (∆R2) when NLP-derived indices (topic proportions and sentiment) are added to a sequential regression model that already includes self-report and behavioral task scores. This measurement will be performed only on the subset of 45 participants who complete the qualitative interview sub-study. The outcome being predicted is the difference in opioid purchase breakpoints between the stress (MAST) and no-stress conditions. |
Countries
United States
Contacts
CONTACTSuky Martinez, PhD
PRINCIPAL_INVESTIGATORSuky Martinez, PhD
Johns Hopkins University
Outcome results
None listed