Project Summary  

*This project was terminated due to issues relating to its study sites and recruitment.

PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project.

What is the research about?

People may have Opioid Use Disorder if they use opioids but can’t cut down or stop taking them, go through withdrawal, or build up a tolerance to them and have other health or life problems. Primary care clinics often don’t offer treatment for Opioid Use Disorder. Clinics that do treat Opioid Use Disorder may not use the types of care proven to help people recover from opioid use. These types of care include medicine, counseling, support from peers, and offering rewards for taking part in treatment.

The research team wants to compare two ways of treating Opioid Use Disorder. One way involves patients getting medicine and counseling from a traditional treatment program that focuses on substance use. The other way is a newer approach in which a team offers medicine, well-researched counseling methods, rewards, peer support, and other services. All these services are within a single clinic where patients get their primary care.

Who can this research help?

Clinic directors can use results from this study to decide which types of opioid treatment to offer. Patients and families can use the study results as they are considering which types of care would best meet the individual patient’s needs.

What is the research team doing?

The team is working with four primary care clinics in the mid-Atlantic area. In the main trial, the team is recruiting 800 patients age 18 and older who have Opioid Use Disorder and get treatment at primary care clinics or at substance use clinics nearby. The team is assigning patients, by chance, to get treatment for Opioid Use Disorder in their own primary care clinic or a specialty clinic.

Patients who get their treatment at their own clinic take part in a program called Personalized Addiction Treatment to Health, or PATH, which offers

• Cognitive behavioral therapy to learn new patterns of healthy thinking when feeling stressed. Patients meet with a counselor twice a week for 13 weeks, then weekly for 13 more weeks, then as needed for 6 months.
• Money as a reward for taking part in therapy and staying on medical treatment
• Treatment with medicines that block some of the effects of opioids, reduce withdrawal symptoms and reduce the desire to take opioids
• Meetings with a peer specialist twice a week for 13 weeks, weekly for 13 more weeks, and as needed for 6 months. Peer specialists are counselors who have experienced addiction themselves and now work to help other patients recover.

Patients who get treatment for opioid use outside of their primary care clinic go to clinics that specialize in treating substance use disorders. Treatment at these clinics might include the same type of medicine to block the effect of opioids or reduce cravings. Patients also may have individual or group sessions with counselors several hours per week.

The team is following up with patients every three months for 18 months to see if they are using opioids, other drugs, or alcohol. The team also is tracking whether patients go to treatment sessions and fill their prescriptions and how often they go to the doctor or emergency room for any reason. Patients are answering questions about their quality of life, risk for HIV, work, family, and mental health.

Patients with Opioid Use Disorder, state Medicaid agencies, health policy experts, healthcare providers, and community groups worked with the research team to plan the study.  

Research methods at a glance

Design Elements	Description
Design	Randomized controlled trial
Population	Adults age 18 or older with Opioid Use Disorder who are appropriate for outpatient treatment based on American Society of Addiction Medicine criteria
Interventions/ Comparators	PATH treatment, including cognitive behavioral therapy, contingency management rewards for recovery behaviors, medication-assisted treatment with daily buprenorphine or monthly extended-release naltrexone, peer recovery specialist support, psychiatrist consultation as needed Intensive outpatient treatment, typically including medication-assisted treatment with daily buprenorphine or monthly extended-release naltrexone, individual and group therapy, psychiatrist consultation as needed
Outcomes	Primary: change in substance abstinence (urine testing), change in retention in treatment Secondary: service utilization, quality of life, HIV risk behaviors, employment, family and social functioning, psychiatric comorbidities
Timeframe	18-month follow-up for primary outcomes

Project Details

Principal Investigator

David R. Gastfriend, MD

Project Status

Terminated

Project Title

A Simple Large Trial of Patient-Centered Care for Opioid Use Disorders in Federally Qualified Healthcare Centers and Specialty Care Settings

Board Approval Date

March 2017

Project End Date

June 2019

Organization

Public Health Management Corporation^

Year Awarded

2017

State

Pennsylvania

Project Type

Research Project

Health Conditions  

Mental/Behavioral Health

Addiction/Substance Abuse

Intervention Strategies

Behavioral Interventions
Care Coordination
Drug Interventions
Other Clinical Interventions
Other Health Services Interventions
Training and Education Interventions

Populations

Racial/Ethnic Minorities
Low Income
LGBTQ

Funding Announcement

Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes

Project Budget

$11,512,619

Study Registration Information

HSRP20181677

NCT03367234