Project Summary

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, is a pattern of using opioids, such as prescription pain medicines or heroin, that can lead to addiction or overdose. To treat OUD, doctors often prescribe a medicine called buprenorphine. This medicine helps lessen symptoms of opioid withdrawal, such as pain and nausea. But starting patients on OUD medicine can be hard. Patients must stop taking opioids and start going through withdrawal before they can start taking OUD medicine. Doctors must monitor withdrawal symptoms carefully to see when a patient should take the first dose. Also, many people stop taking the OUD medicine or start using opioids again. Improving patients’ experiences with starting OUD medicine may help them stay in treatment.

In this study, the research team is comparing three ways for patients to start taking OUD medicine: at home, at the doctor’s office, or through telehealth. In telehealth, doctors have visits with patients by phone or video.

Who can this research help?

Results may help doctors and patients with OUD when considering ways to start taking medicine for OUD.

What is the research team doing?

The research team is enrolling 1,400 patients who are starting medicine for OUD across the United States. The team is assigning patients by chance to one of three ways to start OUD medicine:

  • At home. Patients start taking the medicine when they have withdrawal symptoms. If they still have the same or worse withdrawal symptoms an hour later, patients take another dose of medicine. Patients follow the doctor’s guidance to repeat this process up to four times until they feel better. Patients see the doctor again within a week of starting the medicine.
  • At the doctor’s office. Office staff ask about withdrawal symptoms before giving patients the medicine. Then, patients stay at the doctor’s office for one hour to see if they have more withdrawal symptoms. Staff give patients more medicine if they still have withdrawal symptoms. Staff can repeat this process for a third dose if patients still have symptoms.
  • During a telehealth visit. Staff from the doctor’s office ask patients about withdrawal symptoms before telling them to start taking the medicine. After an hour, staff contact patients by phone or video to ask about withdrawal symptoms. If patients have symptoms, staff tell them to take another dose of medicine. Staff can repeat this process for a third dose if patients still have symptoms.

To see if patients are taking OUD medicine, the research team is checking if patients fill their prescriptions and how often they get refills. The team is also reviewing patients’ urine test results to see if they are taking their medicine and if they have used opioids. Patients are answering surveys when they start the study and again one, three, and nine months after starting the medicine. Surveys ask about the number of days patients took OUD medicine and opioids, quality of life, relationships with other people, and loneliness.

Patients who have gone through treatment with OUD medicine, clinicians, primary care staff, and judicial system professionals are helping to design and conduct the study.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population 1,400 people ages 16–89 with opioid use disorder
Interventions/
Comparators
  • Starting buprenorphine at home
  • Starting buprenorphine at the doctor’s office
  • Starting buprenorphine during a telehealth visit
Outcomes

Primary: number of days patient took buprenorphine, number of days patient took other opioids

Secondary: quality of life, social connectedness, loneliness, housing and job status

Timeframe 9-month follow-up for primary outcomes

Project Information

Linda Zittleman, MPH, MS
University of Colorado Anschutz Medical Campus
$5,153,416

Key Dates

36 months
November 2019
August 2024
2019

Study Registration Information

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Last updated: November 23, 2021