Team-Based Care for Opioid Use Disorder and Mental Health Disorders

(STAR-COD Trial)

Recruiting at 13 trial locations

Overseen By Abigail Helm, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Must be taking: Buprenorphine, Naltrexone

Must not be taking: High dose benzodiazepines

Disqualifiers: Severe alcohol use disorder, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new team-based care approach for individuals with both opioid use disorder and mental health challenges, such as depression or anxiety. Researchers aim to determine if adding components of the MISSION program, like therapy and peer support, to medication-assisted treatment is more effective than medication alone. Participants will be randomly assigned to groups, each receiving a different combination of treatments. This trial suits individuals who have struggled with opioid use, are currently on medications like buprenorphine or naltrexone, and are dealing with mental health issues. As an unphased trial, it offers a unique opportunity to contribute to innovative care strategies that could improve treatment outcomes for others facing similar challenges.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it seems that participants can continue medications like buprenorphine or naltrexone for opioid use disorder.

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

Research shows that the treatments tested in this study have been promising in other contexts. For MISSION Critical Time Intervention (CTI), studies suggest this method can assist individuals with mental health and substance use issues. It provides support during critical periods to stabilize individuals and reduce risks like homelessness.

MISSION Dual Recovery Therapy (DRT) has also shown positive results in other studies. Participants in this therapy spent fewer nights in jail and reduced drug use, indicating it could be safe and beneficial.

MISSION Peer Support has been studied as well. Peer support involves individuals with similar experiences helping each other. Evidence shows it can effectively treat opioid use disorder. Participants in peer support programs often start medications for their disorder and make progress in their recovery.

Overall, these treatments appear well-tolerated. Research has not reported any major safety concerns. However, each treatment may work differently for different individuals. It's important to discuss potential risks and benefits with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for opioid use disorder and mental health disorders because they integrate a comprehensive approach with multiple components. Unlike standard treatments that might focus solely on medication, these interventions combine Critical Time Intervention (CTI), Dual Recovery Therapy (DRT), and Peer Support (PS) alongside Medication for Opioid Use Disorder (MOUD). This holistic method aims to address both substance use and mental health issues simultaneously, offering support through therapy and peer networks, and potentially leading to more sustainable recovery. By targeting not just the addiction but also the underlying mental health conditions, these treatments could offer a more effective and supportive path to recovery.

What evidence suggests that this trial's treatments could be effective for opioid use and mental health disorders?

Research has shown that the MISSION approach, which combines Critical Time Intervention (CTI), Dual Recovery Therapy (DRT), and Peer Support, can assist individuals with both opioid addiction and mental health issues. In this trial, some participants will receive the Full MISSION approach, which includes CTI, DRT, Peer Support, and Medication for Opioid Use Disorder (MOUD). CTI improves mental health and supports community reintegration. DRT addresses both substance use and mental health, aiming to reduce opioid use and enhance mental health. Peer Support offers encouragement from those with similar experiences, positively impacting individuals with substance use disorders. Together, these components aim to increase treatment participation, reduce substance use, and improve mental health. ^{6 7 8 9 10}

Who Is on the Research Team?

David Smelson, PsyD

Principal Investigator

University of Massachusetts, Worcester

Are You a Good Fit for This Trial?

This trial is for adults fluent in English or Spanish with opioid use disorder (OUD) and a co-occurring mental health disorder like depression, anxiety, trauma-related disorders, bipolar, or schizophrenia. Participants can be new to treatment or have relapsed while on medications such as buprenorphine or naltrexone. Excluded are those acutely psychotic/suicidal/homicidal, severely addicted to alcohol needing detoxification, or unable to consent.

Inclusion Criteria

Potentially have a concurrent substance use disorder in addition to opioids

I have opioid use disorder and recently relapsed despite being in a treatment program.

I have a stable mental health condition but my symptoms have recently worsened.

Exclusion Criteria

Have concurrent severe alcohol use disorder or high dose benzodiazepine needing detoxification

I am unable to understand and give consent for medical procedures.

Are acutely psychotic, acutely suicidal with a plan, or homicidal

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 months of psychosocial treatment combined with assertive outreach and MOUD

6 months

Regular visits as per treatment protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Medication for Opioid Use Disorder
• MISSION Critical Time Intervention
• MISSION Dual Recovery Therapy
• MISSION Peer Support

Trial Overview The study tests the MISSION model—a comprehensive care approach—against standard medication treatments for OUD alone. It examines if adding MISSION's therapy and support services improves patient engagement and outcomes in substance use and mental health over just using medications like buprenorphine/naltrexone.

How Is the Trial Designed?

Group I: MOUD only Experimental Treatment 1 Intervention

MOUD

Group II: Full MISSION Experimental Treatment 4 Interventions

CTI + DRT + PS + MOUD

Group III: DRT & PS Experimental Treatment 3 Interventions

DRT + PS + MOUD

Group IV: CTI & PS Experimental Treatment 3 Interventions

CTI + PS + MOUD

Group V: CTI & DRT Experimental Treatment 3 Interventions

CTI + DRT + MOUD

MISSION Critical Time Intervention is already approved in United States for the following indications:

Approved in United States as MISSION for:

• Co-occurring opioid use and mental health disorders

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Harvard Medical School (HMS and HSDM)

Collaborator

Trials

208

Recruited

1,421,000+

Cornell University

Collaborator

Trials

179

Recruited

14,090,000+

University of Texas at Austin

Collaborator

Trials

387

Recruited

86,100+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

University of Massachusetts, Lowell

Collaborator

Trials

21

Recruited

10,300+

Published Research Related to This Trial

A pilot study involving 46 substance-dependent patients showed that participating in a brief motivational interviewing group during detoxification is linked to a higher likelihood of maintaining abstinence after discharge.

Factors such as being male, having a positive mindset towards change, and satisfaction with the therapy and therapist were associated with longer periods of abstinence, highlighting the importance of these elements in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing group at inpatient detoxification, its influence in maintaining abstinence and treatment retention after discharge. Bachiller, D., Grau-López, L., Barral, C., et al.[2017]

The Buprenorphine Team (B-Team) program successfully initiated buprenorphine therapy for 398 patients with opioid-use disorder (OUD) from September 2018 to January 2023, demonstrating its effectiveness in hospital-based treatment.

Retention rates for ongoing outpatient care were promising, with 36% of eligible patients attending follow-up appointments between 6 and 12 months, indicating that this model can sustain treatment engagement for patients after hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital-based opioid treatment: Expanding and sustaining the model in Texas. Moriates, C., Boulton, A., Walker, B., et al.[2023]

The study developed a new collaborative care model called CLARO, specifically designed to improve treatment for patients with co-occurring opioid use disorders (OUD) and mental health issues like depression and PTSD, using input from a diverse team of stakeholders.

Twelve key adaptations were made to the traditional collaborative care approach, including the use of community health workers and modified training protocols, aimed at enhancing the model's effectiveness and acceptability in low-resource healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO): process of adapting collaborative care for co-occurring opioid use and mental disorders. Osilla, KC., Dopp, AR., Watkins, KE., et al.[2022]

A pilot randomized controlled trial involving 25 hospitalized adults with opioid use disorder (OUD) tested a peer recovery coach intervention to improve retention in medications for opioid use disorder (MOUD) after discharge.

The study found no significant differences in MOUD retention rates, hospital readmissions, or time to treatment discontinuation between the recovery coach intervention group and the treatment-as-usual group, indicating that the intervention did not enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Peer Recovery Coach Intervention for Hospitalized Patients with Opioid Use Disorder: A Pilot Randomized Controlled Trial. Suzuki, J., Martin, B., Loguidice, F., et al.[2023]

A 6-month outpatient program combining methadone therapy, group therapy, and case management led to significant improvements in heroin-addicted patients, with 52% completing the program and an average treatment duration of 19 weeks.

Patients showed reduced illicit drug use and improved health and social conditions, such as obtaining medical coverage and better housing, indicating that intensive psychosocial support alongside opioid substitution can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging hospitalized heroin-dependent patients into substance abuse treatment. Aszalos, R., McDuff, DR., Weintraub, E., et al.[2019]

Patient activation, which involves actively participating in treatment decisions and taking responsibility for recovery, is crucial for positive outcomes in individuals with opioid use disorder (OUD) in intensive outpatient treatment (IOT) programs, as identified through interviews with 14 participants.

The study identified six key types of patient activation behaviors, highlighting the importance of collaboration with staff and self-determination in recovery, suggesting that IOT programs should foster these active roles while being cautious about the timing of certain interventions to avoid hindering recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Activation of Persons With Opioid Use Disorder in Intensive Outpatient Treatment. Keen, A., Lu, Y., Oruche, UM., et al.[2022]

The PROUD trial is testing a collaborative care model in primary care settings to improve treatment access for opioid use disorder (OUD), involving over 170,000 patients across six health care systems.

The trial aims to measure the effectiveness of this model by comparing the number of days patients receive medication for OUD and the reduction in acute health care utilization, providing valuable insights for future OUD management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment. Campbell, CI., Saxon, AJ., Boudreau, DM., et al.[2022]

The Community Access to Specialized Treatment (CAST) initiative successfully provided enhanced substance abuse and psychiatric services to 81 opioid-dependent outpatients, resulting in a 43% completion rate of the program within an average of 101 days.

Patients showed high adherence to counseling services, with 93% attending individual sessions and 73% attending group sessions, indicating the program's effectiveness in engaging participants in their recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using enhanced and integrated services to improve response to standard methadone treatment: changing the clinical infrastructure of treatment networks. Neufeld, K., Kidorf, M., King, V., et al.[2021]

The Peer Activate intervention, delivered by peer recovery specialists, showed high feasibility and acceptability, with 86.5% of participants initiating the program and 81.3% completing at least 75% of sessions, indicating strong engagement among low-income, minoritized populations.

Participants in the Peer Activate program had a significantly higher retention rate in methadone treatment (88.6%) compared to those receiving standard treatment, along with improved adherence to methadone and reduced substance use frequency, highlighting the potential effectiveness of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer recovery specialist-delivered, behavioral activation intervention to improve retention in methadone treatment: Results from an open-label, Type 1 hybrid effectiveness-implementation pilot trial. Magidson, JF., Kleinman, MB., Bradley, V., et al.[2023]

A pilot study evaluated a peer-led version of the Seeking Safety (SS) program for 18 women with co-occurring substance use disorder (SUD) and trauma-related issues, showing significant improvements in trauma symptoms, mental health, and coping skills.

Participants reported high satisfaction with the peer-led SS approach, indicating its potential as an effective intervention for those facing both SUD and trauma-related challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-led seeking safety: results of a pilot outcome study with relevance to public health. Najavits, LM., Hamilton, N., Miller, N., et al.[2018]

A qualitative study involving 26 patients receiving methadone treatment found that a peer recovery specialist-delivered behavioral activation intervention (Peer Activate) was perceived as acceptable and feasible, particularly due to its flexibility and the supportive qualities of the peer specialists.

Participants highlighted the importance of connecting with the intervention content and building skills, while also noting stigma related to substance use and methadone treatment as barriers to engagement, suggesting that addressing these issues could enhance treatment retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"You rise up and then you start pulling people up with you": Patient experiences with a peer-delivered behavioral activation intervention to support methadone treatment. Kleinman, MB., Hines, AC., Anvari, MS., et al.[2023]

During the COVID-19 pandemic, a community-based opioid treatment program successfully transitioned to telehealth services for counseling and support, which initially saw a drop in patient volume but ultimately led to increased patient engagement over time.

The study suggests that future policies should support the continued use of telehealth and flexible prescribing practices for opioid use disorder, highlighting the importance of accessible care during public health crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth sustains patient engagement in OUD treatment during COVID-19. Langabeer, JR., Yatsco, A., Champagne-Langabeer, T.[2021]

The PEER program effectively identified clients with substance use disorders who had high needs for social support and were at risk of recidivism, demonstrating its potential to address complex health and social issues among this population.

Despite challenges in client contact and funding stability, the program's sustainability was rated as stable, suggesting that with adjustments to service delivery and risk stratification, it could be further optimized for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Where It Really Counts: Feasibility and Potential of the Peer Engaged Empowered Recovery Program for Substance-Dependent Jail Inmates. Parekh, T., Cuellar, AE., Farina-Morse, M., et al.[2022]

The pilot program aimed at reducing readmission rates for opioid use disorder (OUD) after inpatient detoxification showed a decrease in readmission rates in the treatment facilities, but these changes were not statistically significant when compared to control facilities, indicating that more effective strategies are needed.

Despite the implementation of individualized treatment plans, there was no significant improvement in the use of lower levels of care or medications for OUD, suggesting that while the program may have had some impact, it did not fully address the ongoing treatment needs of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of 90-day inpatient detoxification readmission for opioid use disorder by a community-based life-changing individualized medically assisted evidence-based treatment (C.L.I.M.B.) program: A quasi-experimental study. Luo, Z., Roychoudhury, C., Pompos, WS., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11392628/

A Half Fractional Factorial Randomized Controlled Trial This protocol paper describes a randomized controlled trial comparing MISSION and medication for opioid use disorder (MOUD), its multicomponent parts along with ...

2. criticaltime.org criticaltime.org/category/mental-health/

mental health Led by Dr. Jennifer Manuel of the University of Connecticut, the review concludes that CTI demonstrated a consistent positive impact on two primary outcomes– ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05713695

Study Details | NCT05713695 | Supporting Treatment ... This study seeks to evaluate the effectiveness of MISSION, a multi-component team approach, versus linkage with a Peer Specialist on improving outcomes among ...

4. sciencedirect.com sciencedirect.com/science/article/am/pii/S1551714424002519

Protocol of a randomized controlled trial examining ... MISSION model.33 MISSION includes: (1) Critical Time Intervention (CTI), comprising. 110 time-limited assertive outreach and case management to address ...

5. naco.org naco.org/resource/pretrial

Pretrial Services for People with Opioid Use Disorder Critical Time Intervention: a time-limited intervention to facilitate community integration and continuity of care during periods of transition.2,20; Supported ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8117118/

Collaborative Care in the Treatment of Opioid Use Disorder ... In this study, we will investigate whether collaborative care models in primary care that address both mental illness and OUD result in better outcomes than ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11938673/

Impact of an opioid use disorder medication ... It is important to evaluate how medication for opioid use disorder (MOUD) implementation interventions impact downstream outcomes, ...

8. criticaltime.org criticaltime.org/research_categories/mental-illness/

mental illness The aim of this study is to test whether the adapted CTI-HD reduces the risk of homelessness for people with hoarding disorder who have been threatened with ...

9. omh.ny.gov omh.ny.gov/omhweb/adults/cti_team_program_guidance.pdf

Adult Critical Time Intervention Teams (CTI) Program Guidance • Provide therapeutic interventions for both mental health and substance use disorders,. • Educate individuals about mental health, treatment, and recovery,.

10. ojin.nursingworld.org ojin.nursingworld.org/table-of-contents/volume-25-2020/number-3-september-2020/development-of-a-novel-behavioral-intervention-for-opioid-use-disorders/

Development of a Novel Behavioral Intervention for Opioid ... The purpose of this article is to describe the process of developing and organizing the novel behavioral manual-based treatment protocol for use among ...