Prevention Interventions for Opioid Use Disorder

Overseen By Carrie Bourque

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Acute sexual assault, Cancer, Pregnancy, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find new ways to prevent opioid misuse and addiction among older teens and young adults. It tests different combinations of brief counseling sessions, known as Brief Intervention (BI), and ongoing support through either a digital portal or usual care. The goal is to identify the most effective and affordable strategies to help those at risk. Suitable participants include individuals aged 16-30 who use prescription opioids and have other risk factors such as marijuana use, binge drinking, or depression. As an unphased trial, this study provides a unique opportunity to contribute to innovative prevention strategies for opioid misuse.

Do I have to stop taking my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that brief interventions (BI) are generally easy for people to handle. One study found that using BI for alcohol issues reduced the likelihood of needing new opioid prescriptions or developing an opioid use disorder (OUD). This suggests BI might be safe and helpful in similar situations. Another study on BI for unhealthy drug use found it had a lasting positive effect, though it didn't provide detailed safety information.

Regarding the use of a portal for treatment, data is less detailed, but patients generally gave positive feedback about using portals for OUD care. They found it useful for managing their treatment, suggesting it is a safe option.

Overall, both BI and the portal are considered safe based on their use in similar situations. Studies have not reported any major negative side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for opioid use disorder because they focus on integrating brief interventions (BI) with digital and enhanced care approaches. Unlike traditional methods like medication-assisted treatment and counseling, these interventions combine BI with a digital portal or enhanced usual care (EUC), potentially offering more personalized and accessible support. The use of a digital portal aims to provide continuous engagement and support for patients, which might improve adherence and outcomes. Additionally, the flexibility of adding EUC at different stages allows for a tailored approach to patient care, which could be more effective in preventing opioid misuse.

What evidence suggests that this trial's treatments could be effective for preventing opioid use disorder?

Research has shown that short, focused conversations, known as brief interventions (BI), can help reduce opioid misuse. For instance, one study found that BI for unhealthy drug use led to better outcomes, such as longer treatment retention and improved family relationships. Additionally, brief interventions for alcohol use in primary care settings were linked to a lower risk of receiving new opioid prescriptions or being diagnosed with opioid use disorder (OUD).

In this trial, participants may receive a combination of BI and a telehealth portal, which can enhance care by organizing and connecting different services, potentially leading to better outcomes for those at risk of opioid misuse. Another group in this trial will receive Enhanced Usual Care (EUC), which may also be combined with the portal. While medications remain the most effective treatment for OUD, combining them with these interventions can help prevent the development of opioid misuse. ^{6 7 8 9 10}

Who Is on the Research Team?

Erin Bonar

Principal Investigator

University of Michigan

Maureen Walton, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for young people aged 16-30 who visit a Michigan Medicine emergency department, can communicate in English, and are able to consent. They must have used prescription opioids and have at least one risk factor like drug misuse or depression. Pregnant individuals, those with recent injection drug use, acute sexual assault victims, suicidal individuals, or current cancer patients are excluded.

Inclusion Criteria

Seeking care in Michigan Medicine emergency department (ED)

I am mentally capable of understanding and agreeing to participate.

I use prescription opioids and have at least one other risk factor or misuse opioids.

Exclusion Criteria

I am currently dealing with an acute sexual assault, feeling acutely suicidal, or am diagnosed with/receiving treatment for cancer.

You have used injection drugs in the past year.

Current pregnancy at baseline

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Brief intervention (BI) or Enhanced Usual Care (EUC) delivered at intake, followed by either Portal or EUC after 4 weeks

4 weeks

1 visit (in-person) at intake, followed by telehealth

Follow-up

Participants are monitored for changes in opioid misuse and related behaviors at 3, 6, and 12 months

12 months

Telehealth follow-ups at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Brief intervention (BI)
• Enhanced Usual Care (EUC)
• Portal

Trial Overview The study tests prevention strategies for opioid misuse among older adolescents and young adults using brief interventions (BI), a portal system for follow-up care, and enhanced usual care (EUC). It aims to identify cost-effective methods that prevent the development of opioid use disorders after an emergency department visit.

How Is the Trial Designed?

Group I: Enhanced Usual Care (EUC) then Portal Experimental Treatment 2 Interventions

EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake.

Group II: Brief intervention (BI) then Portal Experimental Treatment 2 Interventions

The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake.

Group III: Brief intervention (BI) then Enhanced Usual Care (EUC) Experimental Treatment 2 Interventions

The BI will be delivered at intake and EUC will be added 4 weeks later.

Group IV: Enhanced Usual Care (EUC) then EUC Active Control 1 Intervention

EUC will be delivered at intake and delivered again 4 weeks later.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9198157/

Efficacy of Brief Intervention for Unhealthy Drug Use in ... This study aims to determine the efficacy of BI for unhealthy drug use and the expected length of effects, and describe subgroup analyses by outpatient setting.

2. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.20230683

Associations Between a Primary Care-Delivered Alcohol ... The VA's standard alcohol-related brief intervention is associated with subsequent lower odds of a new opioid prescription or a new OUD diagnosis.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871625000559

A randomized controlled trial of effectiveness of brief ... The intervention group had a higher retention than the control group (64 % versus 42 %). There was improvement in overall family functioning of ...

4. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7325a1.htm

Treatment for Opioid Use Disorder: Population Estimates In 2022, 3.7% of US adults aged ≥18 years needed OUD treatment. Among these, only 25.1% received medications for OUD.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2817002

Public Health Interventions and Overdose-Related ... The model projected decreases of up to 35.2% in nonfatal and 36.6% in fatal opioid-involved overdoses among persons with OUD.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12445236/

Implementation Strategies to Enhance Safety-Net Hospitals ... Implementation Strategies to Enhance Safety-Net Hospitals' Adoption of Screening, Brief Intervention, and Referral to Treatment for Opioid Use ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10993074/

Public Health Interventions and Overdose-Related ... This decision analytical model estimates the projected 3-year association between public health interventions and opioid overdose-related outcomes

8. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.20230683

Associations Between a Primary Care-Delivered Alcohol ... The VA's standard alcohol-related brief intervention is associated with subsequent lower odds of a new opioid prescription or a new OUD ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S268811522500150X

Emergency Department-Based Medication for Opioid Use ... The number of patients inducted declined yearly; however, inpatient admissions for OUD declined less. The overall retention rate was 36.5% at 1 month and 28.8% ...

10. link.springer.com link.springer.com/article/10.1007/s11606-022-07543-z

Efficacy of Brief Intervention for Unhealthy Drug Use in ... This study aims to determine the efficacy of BI for unhealthy drug use and the expected length of effects, and describe subgroup analyses by outpatient setting.