Opioid use disorder (OUD) is a serious public health problem that has reached epidemic levels in the United States. Opioid overdose deaths have increased by over 400% since 1999 and are now a leading cause of premature death. When people with OUD step down from prison, inpatient detoxification (detox), or residential treatment, the risk of overdose death is particularly high. Buprenorphine (BUP) can reduce opioid overdose risk by 50%, but its blocking effect depends on full medication adherence. Retention in outpatient BUP is low with less than 50% remaining in treatment at 6 months. Incomplete BUP adherence is common and is associated with relapse. Recent research has demonstrated that attention to patients' beliefs about BUP may be an important component to increase the use of BUP during high-risk periods for overdose. Novel innovative approaches to prevent opioid overdose deaths that can support safe transition from inpatient or locked environments to outpatient BUP treatment while enhancing medication adherence are rapidly needed to achieve meaningful reductions in opioid overdoses. We have conducted pilot studies of a technology-based mobile device application integrating remote motivational enhancement (RME) sessions with daily supervised dosing from secure electronic pill dispensers via videoconference to encourage adherence during BUP treatment called MySafeRx. This program demonstrated high levels of medication adherence among high-risk young adults with OUD and led to 50% reduction in illicit opioid use. However, less is known about the initial engagement period with BUP and whether offering RME sessions via video starting during inpatient detox could help encourage people participate in outpatient BUP treatment with daily supervised dosing. This project will conduct a randomized controlled trial among 160 people with OUD to evaluate the effect of RME sessions on post-detox engagement in BUP treatment with daily dosing. The primary aim is to examine the effect of RME sessions versus information alone on treatment engagement during the transition from inpatient detox to daily outpatient supervised dosing of buprenorphine. We expect that participants enrolled in RME arm will be engaged in outpatient BUP treatment with significantly higher proportion receiving > 10 of 14 observed BUP doses by the end of week 2 versus information alone. Secondary aims will examine the effect of those in RME + MySafeRx versus information + Standard Care (in-person, onsite BUP) on retention in outpatient BUP treatment with daily supervised dosing as well as on illicit opioid use, opioid overdoses, and overdose death rates in the 6-months after discharge from inpatient detox. We expect this study will generate new knowledge about the most effective way to prevent overdose and engage patients in BUP treatment with observed daily dosing, making it easier to increase BUP treatment access and adherence.

Public Health Relevance

Opioid overdoses are a significant problem nationwide and novel interventions that can prevent overdose by improving buprenorphine treatment for opioid use disorder are a public health priority. This study will both investigate the effects of starting remote motivational enhancement during inpatient detoxification on rates of engagement in buprenorphine treatment and evaluate the impact of MySafeRx, a mobile device application which integrates remote motivational coaching with daily observed dosing from secure electronic pill dispensers at home via videoconference, on treatment retention and overdose prevention. Broad dissemination of this new intervention could help communities across the nation expand and advance their capacity to increase buprenorphine treatment engagement and retention, enhance medication adherence, and prevent overdose.

Agency
National Institute of Health (NIH)
Institute
National Center for Injury Prevention and Control (NCIPC)
Type
Research Project (R01)
Project #
1R01CE003039-01
Application #
9698763
Study Section
Special Emphasis Panel (ZCE1)
Project Start
2018-09-30
Project End
2021-09-29
Budget Start
2018-09-30
Budget End
2019-09-29
Support Year
1
Fiscal Year
2018
Total Cost
Indirect Cost
Name
University of South Florida
Department
Other Health Professions
Type
Schools of Arts and Sciences
DUNS #
069687242
City
Tampa
State
FL
Country
United States
Zip Code
33612