Opioid Use DisorderNCT06954402
Resilience Among Individuals With Opioid Use Disorder
A study testing Acute Stress Intervention (MAST-based) and Non-Stress Intervention (NST-based) in people with Opioid Use Disorder, run by Johns Hopkins University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Acute Stress Intervention (MAST-based) and Non-Stress Intervention (NST-based)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 May 2026to 30 Apr 2029
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Can provide informed consent and can comply with study procedures
- Adults aged ≥18 years
- 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])
- Urine sample that tests positive for opioids
- Test negative for pregnancy at screening (females only)
Who cannot join
- Being pregnant or breastfeeding
- Significant mental health or physical disorder, or life circumstances, that is judged by the investigators to interfere with study participation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Johns Hopkins University Bayview Medical Campus
Baltimore, Maryland, 21224
- Recruiting
Johns Hopkins University Bayview Medical Campus
Baltimore, Maryland, 21224
Alec Zhang, BS, 410-550-4121, smart209@jh.edu
About this study
Official title: A Novel Human Laboratory Model of Resilience Among Individuals With Opioid Use Disorder
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.
Read the 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.
- Conditions
- Opioid Use Disorder
- Being tested
- Acute Stress Intervention (MAST-based), Non-Stress Intervention (NST-based)
- Keywords
- opioids, opioid use disorder, stress
- 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.
Acute Stress Intervention (MAST-based)Behavioural
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.
Non-Stress Intervention (NST-based)Behavioural
In this control intervention, participants complete the same battery of laboratory tasks without exposure to the acute stressor.
| Study group | Role | What they receive |
|---|---|---|
| Stress-First Sequence | Experimental | Participants in this arm will first undergo the stress condition using the Maastricht Acute Stress Test (MAST) and then complete the non-stress condition (NST) in a subsequent session. Receives: Behavioral: Acute Stress Intervention (MAST-based); Behavioral: Non-Stress Intervention (NST-based) |
| Non-Stress-First Sequence | Experimental | Participants in this arm will first complete the non-stress condition (NST) and then undergo the stress condition using the Maastricht Acute Stress Test (MAST) in a subsequent session. Receives: Behavioral: Acute Stress Intervention (MAST-based); Behavioral: Non-Stress Intervention (NST-based) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Trait Resilience as assessed by Connor-Davidson Resilience Scale 25 (CD-RISC-25)
Instrument: Connor-Davidson Resilience Scale 25 Score Range: 0-100 Interpretation: Higher scores indicate greater resilience.
Measured: Immediately after completing the task
Cognitive Flexibility: Stroop Color-Word Test reaction time
Instrument: Stroop Color-Word Test Unit: Milliseconds (ms) Interpretation: Higher values = slower performance (worse)
Measured: Immediately after completing the task
Emotional Flexibility: Emotional Stroop Task reaction time
Instrument: Emotional Stroop Task Unit: Milliseconds (ms) Interpretation: Higher values = slower performance (worse).
Measured: Immediately after completing the task
Perceived Controllability (Controllable) assessed by Social Controllability Task (SCT)
Instrument: Social Controllability Task Description: Participants ratings on a 0-100% sliding scale. Interpretation: Higher scores indicate greater perceived control.
Measured: Immediately after completing the task
Secondary outcomes (9)
Subjective Effects of Stress as assessed by the Subjective Effects Visual Analog Scale (VAS) Battery
Instrument: Subjective Effects Visual Analog Scale (VAS) Battery Instrument: VAS (0-100 mm) Interpretation: Higher scores indicate greater intensity of each subjective state.
Measured: Immediately after completing the task
Heart Rate
Unit: Beats per minute (bpm) Interpretation: Higher = increased arousal
Measured: Immediately after completing the task
Systolic Blood Pressure
Unit: mmHg Interpretation: Higher = greater pressure.
Measured: Immediately after completing the task
Diastolic Blood Pressure
Unit: mmHg Interpretation: Higher = greater pressure.
Measured: Immediately after completing the task
Opioid Demand Breakpoint as assessed by the Hypothetical Purchase Task
Instrument: Hypothetical Purchase Task Range: $0-$500 Interpretation: Higher = greater demand.
Measured: Immediately after completing the task
Percentage of Resilience-themed Interview Content
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
Measured: Up to 1 year
Percentage of Spirituality-themed Interview Content
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.
Measured: Up to 1 year
Mean Narrative Sentiment Valence Score
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.
Measured: Up to 1 year
Incremental Variance (∆R2) in Stress-Induced Opioid Demand Predicted by NLP Indices
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.
Measured: From baseline up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start29 May 2026
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Suky Martinez, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954402
- Sponsor's protocol ID
- IRB00438915
- Other IDs
- K08DA058057
- Status last verified
- Jun 2026
- First submitted
- 24 Apr 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Human Laboratory Model of Resilience Among Individuals With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06954402
- Acronym / sponsor ID
- IRB00438915
- Conditions
- Opioid Use Disorder
- Keywords
- opioids, opioid use disorder, stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 29 May 2026 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 1 May 2025 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress-First Sequence | Experimental | Behavioral: Acute Stress Intervention (MAST-based), Behavioral: Non-Stress Intervention (NST-based)Participants in this arm will first undergo the stress condition using the Maastricht Acute Stress Test (MAST) and then complete the non-stress condition (NST) in a subsequent session. |
| Non-Stress-First Sequence | Experimental | Behavioral: Acute Stress Intervention (MAST-based), Behavioral: Non-Stress Intervention (NST-based)Participants in this arm will first complete the non-stress condition (NST) and then undergo the stress condition using the Maastricht Acute Stress Test (MAST) in a subsequent session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Can provide informed consent and can comply with study procedures
- Adults aged ≥18 years
- 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])
- Urine sample that tests positive for opioids
- Test negative for pregnancy at screening (females only)
Key exclusion criteria (2 listed)
- Being pregnant or breastfeeding
- Significant mental health or physical disorder, or life circumstances, that is judged by the investigators to interfere with study participation
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 |
|---|---|---|
| Acute 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. | Behavioural | Non-Stress-First Sequence, Stress-First Sequence |
| Non-Stress Intervention (NST-based)In this control intervention, participants complete the same battery of laboratory tasks without exposure to the acute stressor. | Behavioural | Non-Stress-First Sequence, Stress-First Sequence |
Primary outcome
Self-Reported Trait Resilience as assessed by Connor-Davidson Resilience Scale 25 (CD-RISC-25)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
9 secondary outcomes
Subjective Effects of Stress as assessed by the Subjective Effects Visual Analog Scale (VAS) Battery
Time frame: Immediately after completing the task
Heart Rate
Time frame: Immediately after completing the task
Systolic Blood Pressure
Time frame: Immediately after completing the task
Diastolic Blood Pressure
Time frame: Immediately after completing the task
Opioid Demand Breakpoint as assessed by the Hypothetical Purchase Task
Time frame: Immediately after completing the task
Percentage of Resilience-themed Interview Content
Time frame: Up to 1 year
Percentage of Spirituality-themed Interview Content
Time frame: Up to 1 year
Mean Narrative Sentiment Valence Score
Time frame: Up to 1 year
Incremental Variance (∆R2) in Stress-Induced Opioid Demand Predicted by NLP Indices
Time frame: From baseline up to 1 year
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 23 Jun 2026.
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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.
Suky Martinez, PhD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Stress Intervention (MAST-based) and Non-Stress Intervention (NST-based) in people with Opioid Use Disorder, run by Johns Hopkins University at 2 sites 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 5 inclusion and 2 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 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Suky Martinez, PhD (410-550-0007, smart209@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Trait Resilience as assessed by Connor-Davidson Resilience Scale 25 (CD-RISC-25) (time frame: Immediately after completing the task). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2026.