Stress Interventions for Opioid Use Disorder

Overseen By Suky Martinez, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must be taking: Methadone, Buprenorphine

Disqualifiers: Pregnancy, Breastfeeding, Mental disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

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. ^{1 2 3 4 5}

Why 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. ^{1 6 7 8 9}

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

Can provide informed consent and can comply with study procedures

Urine sample that tests positive for opioids

Test negative for pregnancy at screening (females only)

Exclusion Criteria

Being pregnant or breastfeeding

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

2 sessions

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after completing the experimental sessions

4 weeks

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?

Group I: Stress-First Sequence Experimental Treatment 2 Interventions

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.

Group II: Non-Stress-First Sequence Experimental Treatment 2 Interventions

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 Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A six-week mindfulness-based stress reduction (MBSR) intervention significantly decreased perceived stress, emotional regulation difficulties, and drug cravings in 15 underserved individuals undergoing treatment for opioid use disorder (OUD).

The results suggest that mindfulness interventions can be effective in improving mental health outcomes for vulnerable populations, highlighting the need for larger studies to further validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Brief Mindfulness Intervention in Underserved Individuals Receiving Inpatient Treatment for Opioid Use Disorder: A Pilot Study. Kennelly, NR., Ray, S.[2023]

A 12-week pilot study involving 31 chronically homeless individuals with alcohol dependence showed that extended-release naltrexone (XR-NTX) combined with harm reduction counseling was well-accepted and feasible for this population.

Participants experienced significant reductions in alcohol craving (33%), typical use (25%), peak use (34%), frequency of drinking (17%), and alcohol-related problems (60%), indicating that this approach may effectively support harm reduction goals without requiring abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended-release naltrexone and harm reduction counseling for chronically homeless people with alcohol dependence. Collins, SE., Duncan, MH., Smart, BF., et al.[2022]

Behavioral naltrexone therapy (BNT) was tested in a pilot trial with 47 participants, showing that individuals with higher dependence on opiates, particularly methadone and heroin, had shorter retention in treatment.

The study suggests that those with greater physiological dependence may need more gradual detoxification and intensive behavioral support to improve compliance with naltrexone maintenance therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of retention in naltrexone maintenance for opioid dependence: analysis of a stage I trial. Sullivan, MA., Rothenberg, JL., Vosburg, SK., et al.[2016]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306460319301029

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 ...

2. withpower.com withpower.com/trial/phase-opioid-related-disorders-6-2025-fda1c

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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10836717/

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.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10350319/

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.

5. jsatjournal.com jsatjournal.com/article/S0740-5472(17)30482-8/fulltext

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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31238237/

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.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04920864

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/s13011-020-00264-8

PTSD 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% ...