Resilience Among Individuals With Opioid Use Disorder

NCT06954402 | Recruiting

• 2 other identifiers: IRB00438915K08DA058057
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 2

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.

Conditions

Opioid Use Disorder

Keywords

opioids; opioid use disorder; stress

Outcome Measures

Primary Outcomes (4)

• 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.

  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)

  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).

  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.

  Immediately after completing the task

Secondary Outcomes (9)

• Subjective Effects of Stress as assessed by the Subjective Effects Visual Analog Scale (VAS) Battery

  Immediately after completing the task

• Heart Rate

  Immediately after completing the task

• Systolic Blood Pressure

  Immediately after completing the task

• Diastolic Blood Pressure

  Immediately after completing the task

• Opioid Demand Breakpoint as assessed by the Hypothetical Purchase Task

  Immediately after completing the task

Study Arms (2)

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.

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.

Behavioral: Acute Stress Intervention (MAST-based); Behavioral: Non-Stress Intervention (NST-based)

Interventions

Acute Stress Intervention (MAST-based) BEHAVIORAL

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-First Sequence; Stress-First Sequence

Non-Stress Intervention (NST-based) BEHAVIORAL

In this control intervention, participants complete the same battery of laboratory tasks without exposure to the acute stressor.

Non-Stress-First Sequence; Stress-First Sequence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Being pregnant or breastfeeding
• Significant mental health or physical disorder, or life circumstances, that is judged by the investigators to interfere with study participation

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Johns Hopkins University Bayview Medical Campus

Baltimore, Maryland, 21224, United States

NOT YET RECRUITING

Johns Hopkins University Bayview Medical Campus

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Suky Martinez, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suky Martinez, PhD

CONTACT

410-550-0007; smart209@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 1, 2025
• Study Start (Estimated): May 29, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

US (2)