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Comparative effectiveness of significant other-enhanced office-based opioid treatment (OBOT) in primary care
Investigator (PI): Osilla, Karen
Performing Organization (PO): (Current): RAND Corporation / (310) 393-0411
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2019
Final Year: 2024
Record Source/Award ID: PCORI/ OBOT-2018C2-12876
Funding: Total Award Amount: $5,646,702
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Does a Counseling Program for Friends and Family Help People with Opioid Use Disorder Stay in Treatment? PCORI has identified treatment for opioid use disorder as an important research topic. Patients, clinicians, and others want to learn: Can counseling, support groups, and similar programs help patients who are getting medicine-based treatment for opioid use disorder? To help answer this question, PCORI launched an initiative in 2018 on Psychosocial Interventions with Office-Based Opioid Treatment (OBOT) for Opioid Use Disorder . The initiative funded this research project and others.  This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.   What is the research about? Opioid use disorder, or OUD, happens when people misuse, become addicted to, or take too many opioids at once. Doctors may use medicine to treat OUD. But many people stop taking their medicine, which increases their risk of using opioids again or taking too many opioids at once. Involving friends and family may help people stay on treatment for OUD.  In this study, the research team is testing a counseling program for people who support patients with OUD, including family members, spouses, and friends. The program is called Integrating Support Persons Into Recovery, or INSPIRE. INSPIRE draws from the Community Reinforcement and Family Training, or CRAFT, approach and teaches support people effective ways to help a person with OUD change their behavior. It also teaches ways for them to feel better themselves. The team wants to know if INSPIRE helps patients stay on OUD treatment and if it improves health outcomes for patients and their support people.  Who can this research help? Results may help clinic leaders considering ways to help people with OUD and people who support them. What is the research team doing? The research team is recruiting 500 pairs of adults who are starting treatment for OUD and their support people. Patients are receiving treatment from 17 community health clinics in California.  The team is assigning the support people to receive either INSPIRE or the usual services available at clinics. INSPIRE consists of ten 90-minute in-person group sessions, led by two facilitators. The research team is interviewing patients and support people at the start of the study and again 3 and 12 months later. The team wants to see if INSPIRE helps patients keep using medicine to treat OUD and stop using opioids. In addition, the team is looking to see if INSPIRE improves depression and anxiety for patients and support people. Finally, the team wants to know if INSPIRE works better for some people than others, such as when a support person is a family member, spouse, or friend.  Patients, support people, clinic staff, psychologists, psychiatrists, and health insurers are helping to plan and conduct the study. Research methods at a glance Design Element Description Design Randomized controlled trial Population 500 adults ages 18 and older who are starting buprenorphine and their support person Interventions/ Comparators INSPIRE No intervention Outcomes Primary: patient buprenorphine retention  Secondary: patient opioid and other substance use, patient and support person depression, patient and support person anxiety Timeframe 1-year follow-up for primary outcome.
Abstract Archived: Description of problem: Opioid use disorders (OUDs) have reached an all-time high and have devastating effects on the individual, family, and community. While medication treatment for OUD saves lives, rates of treatment dropout are very high. In addition, existing OUD treatments neglect the impact of untreated OUD on the family and ignore the potential role family members and support persons (SPs) could have on encouraging long-term recovery. Incorporating the patient's support system may be an important way to improve treatment retention. The proposed study evaluates a counseling program for concerned family members, spouses, and friends called Community Reinforcement and Family Training (CRAFT), which is successful at engaging and retaining patients in substance use treatment. While promising, no studies have evaluated whether CRAFT can help patients remain on medication treatment for OUD, provided by community health clinics. If effective, this could save lives and help both patient and family member health outcomes. Methods: We propose a study to recruit 500 patient and SP pairs in community health clinics throughout northern and southern California. We will recruit patients who are starting OUD medication treatment and randomly assign half of the SPs to receive CRAFT; the other half would receive treatment as usual. We will then interview patients and SPs three and twelve months later to evaluate whether patients with CRAFT SPs stay in OUD treatment longer, and whether patient and SP health outcomes improve. Outcomes: We will follow patient and SPs for a year and assess patient retention in OUD treatment. We will also assess patient opioid use, SP health, relationship, and quality of life. We will assess for which patient subgroups CRAFT is most helpful, and we will survey staff to understand the best ways to make CRAFT available to other clinics in the future. Importance to patients: This study is important to patients with OUD because treatment dropout is linked to a substantially greater risk of opioid relapse and overdose. Thus, finding ways to keep patients in treatment is essential. Stakeholder engagement: Our team consists of patients, SPs, clinic staff, psychologists, psychiatrists, statisticians, payers, and other qualified individuals who have dedicated their lives and careers to improving the wellbeing of those affected by opioid and other substance use. We have assembled clinic, patient, and payer/health board stakeholder advisory panels who will guide us in planning and conducting the study and disseminating study results. We will meet with each panel regularly, using a community engagement process that emphasizes joint leadership, open communication, and two-way knowledge exchange. In doing so, we want to create a project that is relevant and meaningful to the community that can be successfully completed. The proposed study not only fills critical gaps in what we know about CRAFT and OUD treatment, but also provides data to inform a much-needed new way to address the opioid epidemic.

MeSH Terms:
  • Ambulatory Care /organization & administration
  • California
  • Communication
  • Community Mental Health Services /*organization & administration
  • Comparative Effectiveness Research
  • Drug Overdose /prevention & control
  • Family Health
  • Friends
  • Humans
  • Mental Health Services /organization & administration
  • Multicenter Studies as Topic
  • Opioid-Related Disorders /*therapy
  • Opioids /*adverse effects
  • Outcome Assessment (Health Care)
  • Outpatients
  • Primary Care /*organization & administration
  • Program Development
  • Quality of Life
  • Relapse
  • Social Support
  • Spouses
Country: United States
State: Massachusetts
Zip Code: 90401
UI: 20202349
CTgovId: NCT04239235
Project Status: Ongoing
Record History: ('2021: Abstract archived and replaced. ',)