Stress Interventions for Opioid Use Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how resilience (the ability to recover from stress) functions in individuals with opioid use disorder (OUD). Researchers aim to determine if tasks measuring resilience align with participants' perceptions of their own resilience in both stressful and non-stressful situations. Participants will undergo a stress test (Acute Stress Intervention, MAST-based) and a non-stress activity (Non-Stress Intervention, NST-based) to assess this. The trial may suit those with OUD who are currently using medications like methadone or buprenorphine and have experienced stress in their daily lives. As an unphased trial, it offers a unique opportunity to enhance understanding of resilience in OUD, potentially benefiting future treatments.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on methadone or buprenorphine for opioid use disorder, you may continue these treatments.
What prior data suggests that these interventions are safe for people with opioid use disorder?
Research shows that clear safety information for the Acute Stress Intervention (MAST-based) in humans is not yet available. This trial is in the "Not Applicable" phase, indicating that the treatment remains in the early stages of testing. There is insufficient information to fully understand its safety.
Similarly, specific safety information for the Non-Stress Intervention (NST-based) is unavailable. Due to the lack of detailed safety data, discussing potential risks with the trial coordinators is important.
Overall, participants should be aware that the safety of these treatments is still under study. Asking questions and understanding any potential risks before joining the trial is crucial.12345Why are researchers excited about this trial?
Researchers are excited about these stress interventions for opioid use disorder because they target the psychological stress that often triggers drug use, which is a different approach from the usual medication-assisted treatments like methadone or buprenorphine. The unique aspect of these interventions lies in the use of the Maastricht Acute Stress Test (MAST) to simulate stress conditions, allowing researchers to explore how stress management can directly impact recovery outcomes. By focusing on stress reduction, these interventions aim to provide a complementary strategy that could enhance the effectiveness of existing treatments by addressing one of the root causes of relapse.
What evidence suggests that this trial's interventions could be effective for opioid use disorder?
This trial will compare two sequences of stress interventions for opioid use disorder (OUD). Participants in one 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. In the other arm, participants will first undergo the stress condition using the MAST and then complete the NST in a subsequent session. Research has shown that managing stress can be very helpful for people with OUD. A program focused on mindfulness and stress reduction has significantly lowered stress, reduced emotional challenges, and decreased drug cravings in people with OUD. The Maastricht Acute Stress Test, used in these programs, helps understand how people react to stress, guiding personalized treatment plans. While specific data on the exact program being tested is not available, similar stress-focused methods have shown promise in reducing stress-related issues for those with OUD. By managing stress better, individuals might find it easier to cope without using opioids.16789
Who Is on the Research Team?
Suky Martinez, PhD
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
This trial is for adults over 18 with opioid use disorder, either meeting DSM-5 criteria or on treatments like methadone. Participants must test positive for opioids and not be pregnant or breastfeeding. They should be able to consent and follow the study's procedures without significant mental or physical health issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Experimental Sessions
Participants complete two experimental sessions in a randomized order: one under a stress condition and one under a non-stress condition, performing tasks to evaluate resilience.
Follow-up
Participants are monitored for safety and effectiveness after completing the experimental sessions
What Are the Treatments Tested in This Trial?
Interventions
- Acute Stress Intervention (MAST-based)
- Non-Stress Intervention (NST-based)
Trial Overview
The study tests how people with opioid addiction respond to stress. It uses two interventions: one that induces acute stress (MAST-based) and another non-stressful task (NST-based), aiming to understand cognitive, emotional, and control aspects of resilience.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Published Research Related to This Trial
Citations
Stress and opioid use disorder: A systematic review
Medication assisted treatment (MAT) is highly effective in reducing illicit opioid use and preventing overdose in individuals with opioid use disorder ...
Stress Interventions for Opioid Use Disorder
A six-week mindfulness-based stress reduction (MBSR) intervention significantly decreased perceived stress, emotional regulation difficulties, and drug cravings ...
An Opioid-Minimizing Multimodal Pain Regimen Reduces ...
The Multimodal Analgesic Strategies for Trauma (MAST) trial demonstrated that an opioid-minimizing multimodal pain regimen (MMPR) reduced opioid exposure.
Efficacy of a Brief Mindfulness Intervention in Underserved ...
This pilot study demonstrates that a brief mindfulness intervention can be effective for underserved individuals with OUD.
Effects of medication assisted treatment (MAT) for opioid ...
First, very few studies of MAT reported functional outcomes; 40 MAT studies that met our study design criteria reported cognitive, physical, occupational social ...
Stress and opioid use disorder: A systematic review
These findings suggest that individuals experience considerable stress in spite of receiving standard treatment for OUD. Psychopharmacological interventions ...
7.
2minutemedicine.com
2minutemedicine.com/evidence-gap-for-acute-pain-outcomes-in-opioid-use-disorder/Evidence gap for acute pain outcomes in opioid use disorder
In this systematic review, evidence for the efficacy of acute pain interventions on individuals with opioid use disorder was generally limited.
NCT04920864 | RTMS, Stress and Opioid Use Disorder
This project will explore whether repetitive transcranial magnetic stimulation (rTMS) might improve treatment outcomes for people with OUD entering methadone ...
9.
substanceabusepolicy.biomedcentral.com
substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-020-00264-8PTSD and opioid use: implications for intervention and policy
Recent studies have found compelling evidence that PTSD symptom severity may undermine OAT retention and outcomes; such that with every 10% ...
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