Newswise — A new clinical trial run by Howard University, the University of Illinois Chicago and the University of Miami Miller School of Medicine will partner with community organizations and sites to bring life-saving care closer to a highly vulnerable population – Black people with opioid use disorder.
The Better Together trial will utilize non-medical neighborhood sites such as churches, community centers and homeless shelters to establish and maintain patients on buprenorphine, an effective medical treatment for opioid dependence. The study, funded by the National Institutes of Health’s National Institute on Drug Abuse, will test the community-focused approach at sites in Chicago, Miami and Washington D.C.
The trial will be co-led by Dr. Niranjan Karnik of UIC, Dr. Richard Schottenfeld of Howard University, and José Szapocznik of UM. The clinical trial builds on the Better Together pilot program developed by Howard University’s department of psychiatry and behavioral sciences, in partnership with its community advisory board.
Supported by the National Drug Abuse Treatment Clinical Trials Network, the study will use a community-engaged hub-and-spoke model of providing treatment to persons with opioid use disorder, with participants receiving counseling and peer support at local neighborhood locations supported by remote prescription and management of buprenorphine from university physicians via telehealth at some sites and at a local community center in Miami that largely serves African Americans.
“We know that there are evidence-based, life-saving interventions that work to treat opioid use disorder,” said Karnik, visiting professor of psychiatry at UIC. “The difficulty is getting them to the people who need them the most.”
Within the broader opioid crisis, Black people suffer drug overdose deaths at a higher rate than other racial groups and lag in the use of proven addiction treatments. Experts cite health care access, the stigma against people who use opioids and mistrust of the medical system as significant barriers to reaching these at-risk patients and enrolling them in care.
Recent policy changes have made it easier to prescribe and distribute buprenorphine, a medication that substitutes for powerful drugs such as heroin or oxycodone and safely decreases craving and withdrawal symptoms. But to be effective, patients must take the drug daily and maintain regular contact with a medical professional for refills and monitoring.
“It is critical that persons who suffer from opioid use disorder stay on buprenorphine until they have made the profound personal and social changes that are needed to promote a drug-free lifestyle. Only then, should these individuals stop taking the medication,” said Szapocznik of the department of public health sciences at UM. “This includes changes in housing, habits, coping and life skills, and most importantly social support networks. The study will be working with community programs that can assist persons in achieving these goals.”
By moving care from medical centers to community locations, the researchers expect multiple benefits for patients receiving treatment for their opioid use disorder. For many people, it will reduce the distance they need to travel for regular visits. Alongside intermittent remote check-ins with physicians, support will also be provided in a comfortable, familiar environment by peers from the patient’s community.
Schottenfeld, professor and chair of the department of psychiatry and behavioral sciences at Howard University, said ideas used in the clinical trial resulted from focus group research and a multi-year partnership between researchers and community advisers in Washington, D.C.
“We tried to understand why Black people with opioid use disorder aren’t coming in for treatment,” Schottenfeld said. “We found that enormous amounts of stigma, misunderstandings about addiction and bias against certain types of treatment are barriers to bringing people in and keeping them in treatment.”
Patients in the new study will follow a treatment program with peer recovery support specialists and community engagement and retention specialists, who have often gone through recovery themselves.
By developing relationships with credible messengers and centering treatment in trusted community organizations and working together with credible messengers in the community, the Better Together program builds on existing community strengths and resources. Schottenfeld said the pilot has so far succeeded in attracting and engaging people who need treatment closer to home provided by people they trust.
Participants in the Better Together trial will be compared against a control group receiving buprenorphine and related support in a standard-of-care medical clinic environment. Researchers will examine not only the medical outcomes of the treatment but also factors such as retention and patient satisfaction that would help effectively serve opioid users over the long term.
The Better Together trial will concentrate its initial activities in areas of the three cities hard hit by the opioid crisis. In the first phase of the study, research teams will form community advisory boards in their respective locations and select key community partner organizations and potential treatment sites embedded within the priority neighborhoods.
The trial is funded by NIDA grant 3UG1DA049467-05S1 and is part of the National Institutes of Health Helping to End Addiction Long-Term Initiative. The total grant is for five years and $14.2 million, which will be shared by the three institutions.
More information about the study will be available at the NIDA Clinical Trials Network website under CTN-0144.
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