Collaborative Care for Substance Use Disorders

Recruiting at 7 trial locations

Overseen By Joseph Lurio, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: MOUD

Disqualifiers: Pregnancy, Jail, Recent SUD treatment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 21 months

350 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this trial is to test the efficacy of a collaborative care intervention to address opioid- and/or stimulant-involved polysubstance use in adult primary care patients with moderate to severe substance use disorders (SUD). The primary aims are to reduce days of opioid use (illicit or nonmedical opioid use), days of illicit stimulant use (cocaine, methamphetamine), and days of heavy alcohol use.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently being treated with medication for opioid use disorder (MOUD) and do not have moderate to severe alcohol or stimulant use disorder, you may be excluded from participating.

What data supports the effectiveness of the treatment Co-Care for substance use disorders?

Research shows that coordinating medical and substance use disorder services, like integrating behavioral health staff within primary care teams, leads to better health outcomes. Additionally, a hospital-based collaborative care team improved medication uptake and follow-up care for substance use disorders, suggesting that similar collaborative approaches could be effective. ^{1 2 3 4 5}

Is Collaborative Care for Substance Use Disorders safe for humans?

In a study involving 1,687 participants with substance use disorders, 12% experienced serious adverse events, but none were related to the treatment itself. This suggests that the treatment is generally safe for humans. ^{6 7 8 9 10}

How is the Co-Care treatment for substance use disorders different from other treatments?

Co-Care is unique because it uses a collaborative care approach, which involves a team-based model to integrate behavioral health staff within primary care settings. This approach aims to improve treatment access, quality, and outcomes by coordinating medical and substance use disorder services, which is not commonly practiced in other treatments. ^{5 11 12 13 14}

Research Team

Jennifer McNeely, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for adults with moderate to severe substance use disorders involving opioids, stimulants, or alcohol. Participants must be over 18, speak and understand the study language, and have used multiple substances in the past month. Primary care providers enrolled in the study can also join. Not eligible if they don't meet these criteria.

Inclusion Criteria

a) Patients having alcohol use disorder without an opioid or stimulant SUD are required to have current opioid or stimulant use, as measured on the TAPS tool or baseline monthly survey.

I have used two or more substances, including opioids or stimulants, non-medically in the last month.

I have used opioids or alcohol heavily for more than 10 days, or stimulants for more than 7 days in the last month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Co-Care intervention, including Nurse Care Manager visits, addiction specialist consultations, and health coaching sessions

21 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Co-Care

Trial Overview The Co-Care trial tests a collaborative approach to treat polysubstance abuse in primary care settings. It includes addiction specialist consultations, nurse visits, health coaching sessions, educational materials for patients and support for primary care providers.

Participant Groups

Group I: Co-Care Experimental Treatment 4 Interventions

Patient participants with providers will receive primary care treatment plus the full Co-Care intervention which includes: Nurse Care Manager (NCM) visits, Addiction specialist consultations through NCM if indicated, and Health coaching sessions.

Group II: Enhanced Usual Care (EUC) Active Control 2 Interventions

Patient participants with providers will receive primary care treatment as usual plus educational materials.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

The pilot study involving 38 patients showed that the Substance Use Treatment and Recovery Team (START) significantly improved the initiation of medication for alcohol or opioid use disorders during hospitalization, with patients having over six times higher odds of starting treatment compared to usual care.

START also enhanced the likelihood of patients being linked to follow-up care after discharge, with nearly six times higher odds compared to those receiving standard care, indicating its potential effectiveness in supporting recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of a hospital-based substance use treatment and recovery team (START) to improve initiation of medication for alcohol or opioid use disorder and linkage to follow-up care. Ober, AJ., Osilla, KC., Klein, DJ., et al.[2023]

A coalition approach to collaborative care (CEP) significantly reduced alcohol consumption and the likelihood of behavioral health hospitalizations in individuals with comorbid depression and substance use disorders, compared to a technical assistance approach (RS).

CEP also increased the use of faith-based depression services, suggesting that community engagement can enhance treatment options for those struggling with both depression and substance use issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of two quality improvement implementation interventions for depression services in adults with substance use problems. Morton, I., Hurley, B., Castillo, EG., et al.[2022]

Measurement-based care (MBC) could enhance clinical outcomes in substance use disorder (SUD) treatment by improving communication between patients and providers, as well as among clinicians, according to insights from 15 clinicians interviewed.

To increase the adoption of MBC in SUD settings, it should be designed to fit existing workflows, track clinically relevant outcomes like coping skills and motivation, and be presented as a supportive tool rather than a replacement for current practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do clinicians want? Understanding frontline addiction treatment clinicians' preferences and priorities to improve the design of measurement-based care technology. Tauscher, JS., Cohn, EB., Johnson, TR., et al.[2023]

Patients who received more continuity of care services were more likely to engage in ongoing treatment, with this effect being stronger for those with moderate to low psychiatric severity compared to those with high severity.

Engagement in continuing care was identified as the most significant predictor of abstinence, particularly for patients using both alcohol and other drugs, indicating that tailored continuing care interventions can greatly enhance recovery outcomes for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential relationships between continuity of care practices, engagement in continuing care, and abstinence among subgroups of patients with substance use and psychiatric disorders. Schaefer, JA., Cronkite, RC., Hu, KU.[2019]

Integrating behavioral health staff into primary care teams is crucial for effectively coordinating substance use disorder (SUD) services, as it helps facilitate important transitions in patient care.

The study identified operational practices from community health centers that successfully coordinate SUD services, but ongoing coordination remains a challenge, highlighting the need for further research to improve health and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing care for patients with substance abuse disorders at community health centers. Gurewich, D., Prottas, J., Sirkin, JT.[2013]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

In a study involving 1,687 substance-abusing participants over 27,198 person-weeks, 12% experienced serious adverse events (SAEs), but none were deemed related to the psychosocial interventions being tested.

There were no significant differences in the incidence rates of SAEs between those receiving standard care and those receiving additional interventions like contingency management or motivational enhancement, suggesting that these psychosocial treatments are safe in terms of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? Petry, NM., Roll, JM., Rounsaville, BJ., et al.[2021]

A total of 11,999 Adverse Drug Events (ADEs) were identified from 244,992 hospital admissions, indicating a prevalence of 4.9 ADEs per 100 admissions, particularly affecting older adults and linked to longer hospital stays.

Clinical Coding Surveillance (CCS) proved to be a reliable method for monitoring ADEs, with 91% accuracy in classifying ADEs based on clinical documentation, suggesting it can effectively enhance patient safety in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and reliability of clinical coding surveillance for the routine monitoring of adverse drug events in New Zealand hospitals. Ng, J., Andrew, P., Muir, P., et al.[2019]

Adverse drug events (ADEs) are a major cause of preventable harm in hospitals, particularly affecting older adults, prompting the creation of a National Action Plan to enhance medication safety.

The Action Plan focuses on preventing ADEs from three high-risk medication classes: anticoagulants, diabetes agents, and opioids, and emphasizes surveillance, evidence-based prevention, and education for both healthcare providers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing Medication Safety: Establishing a National Action Plan for Adverse Drug Event Prevention. Harris, Y., Hu, DJ., Lee, C., et al.[2019]

In 2001, there were approximately 4.3 million visits to healthcare facilities in the U.S. due to adverse drug events (VADEs), indicating a significant patient safety concern.

The study found that VADEs were more common in elderly patients aged 65-74 and in females, highlighting the need for targeted safety measures in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory care visits for treating adverse drug effects in the United States, 1995-2001. Zhan, C., Arispe, I., Kelley, E., et al.[2019]

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]

The 12-month Collaborative Care (CC) intervention showed that patients with poorly controlled Type 2 Diabetes (T2D) and depression were more likely to maintain significant improvements in depressive symptoms and glucose levels at 36 months compared to those receiving usual care.

While there were no overall differences in health outcomes between the CC and usual care groups at 36 months, patients in the CC group who had improved outcomes at 12 months were more likely to sustain those improvements, indicating the long-term benefits of the CC approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Effects of a Collaborative Care Model on Metabolic Outcomes and Depressive Symptoms: 36-Month Outcomes from the INDEPENDENT Intervention. Suvada, K., Ali, MK., Chwastiak, L., et al.[2023]

In a study of 377 primary care patients with opioid and/or alcohol use disorders, the collaborative care (CC) model significantly increased access to evidence-based treatments compared to usual care, with 39% of CC participants receiving treatment versus only 17% in the usual care group.

CC participants also reported higher rates of abstinence from opioids or alcohol at 6 months (32.8% vs 22.3%), demonstrating that this model is effective in improving treatment outcomes for individuals with substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative Care for Opioid and Alcohol Use Disorders in Primary Care: The SUMMIT Randomized Clinical Trial. Watkins, KE., Ober, AJ., Lamp, K., et al.[2019]

Collaborative documentation (CD) in substance use treatment can enhance person-centered care by reducing documentation time and fostering trust between providers and clients, as reported by 22 treatment providers in focus groups.

While CD shows promise in promoting engagement, it also presents challenges, particularly with mandated populations or those with complex symptoms, highlighting the need for tailored strategies to optimize its use in these contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Collaborative Documentation to Support Person-Centered Care in Substance Use Settings. Matthews, EB., Peral, M.[2023]

References

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

Pilot randomized controlled trial of a hospital-based substance use treatment and recovery team (START) to improve initiation of medication for alcohol or opioid use disorder and linkage to follow-up care. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Outcomes of two quality improvement implementation interventions for depression services in adults with substance use problems. [2022]

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

What do clinicians want? Understanding frontline addiction treatment clinicians' preferences and priorities to improve the design of measurement-based care technology. [2023]

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

Differential relationships between continuity of care practices, engagement in continuing care, and abstinence among subgroups of patients with substance use and psychiatric disorders. [2019]

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

Managing care for patients with substance abuse disorders at community health centers. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. [2013]

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

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Feasibility and reliability of clinical coding surveillance for the routine monitoring of adverse drug events in New Zealand hospitals. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Advancing Medication Safety: Establishing a National Action Plan for Adverse Drug Event Prevention. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Ambulatory care visits for treating adverse drug effects in the United States, 1995-2001. [2019]

11. England 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. [2022]

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

Long-term Effects of a Collaborative Care Model on Metabolic Outcomes and Depressive Symptoms: 36-Month Outcomes from the INDEPENDENT Intervention. [2023]

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

Collaborative Care for Opioid and Alcohol Use Disorders in Primary Care: The SUMMIT Randomized Clinical Trial. [2019]

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

Using Collaborative Documentation to Support Person-Centered Care in Substance Use Settings. [2023]