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

125 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment for stress interventions in opioid use disorder?

Research shows that mindfulness-based stress reduction programs can help decrease drug cravings and improve emotional regulation and stress in people with opioid use disorder. This suggests that stress-focused interventions may be beneficial in improving outcomes for individuals with opioid use disorder. ^{1 2 3 4 5}

Is the stress intervention treatment safe for humans?

The available research does not provide specific safety data for the stress intervention treatment in humans, but it does not report any safety concerns either. ^{5 6 7 8 9}

How does the Acute Stress Intervention (MAST-based) treatment for opioid use disorder differ from other treatments?

The Acute Stress Intervention (MAST-based) treatment is unique because it specifically targets stress management in individuals with opioid use disorder, which is not commonly addressed by standard treatments. This approach could potentially improve treatment retention and outcomes by reducing stress-related cravings and relapses. ^{1 3 4 10 11}

Research Team

Suky Martinez, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

Test negative for pregnancy at screening (females only)

Can provide informed consent and can comply with study procedures

Urine sample that tests positive for opioids

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

A stress-coping profile of opioid dependent individuals entering naltrexone treatment: a comparison with healthy controls. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Stress and opioid use disorder: A systematic review. [2020]

4. Ireland pubmed.ncbi.nlm.nih.gov

Longitudinal patterns of momentary stress during outpatient opioid agonist treatment: A growth-mixture-model approach to classifying patients. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Behavioral strategies to reduce stress reactivity in opioid use disorder: Study design. [2021]

6. Ireland pubmed.ncbi.nlm.nih.gov

Stress indices in methadone maintenance treatment - Cross sectional and follow up study. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Extended-release naltrexone and harm reduction counseling for chronically homeless people with alcohol dependence. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Seeking Safety plus Exposure Therapy: an outcome study on dual diagnosis men. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Predictors of retention in naltrexone maintenance for opioid dependence: analysis of a stage I trial. [2016]

10. Ireland pubmed.ncbi.nlm.nih.gov

Forty-eight years of research on psychosocial interventions in the treatment of opioid use disorder: A scoping review. [2021]

11. Ireland pubmed.ncbi.nlm.nih.gov

Perceived stress and substance use in methadone-maintained smokers. [2021]