NCT06696157 | NOT YET RECRUITING | Opioid Use Disorder

Detailed Description:

The United States is experiencing an opioid epidemic marked by significant overdose deaths. Although medications for opioid use disorder (MOUD) are efficacious, the rates of MOUD initiation and retention are alarmingly low, with 11% of patients with an OUD diagnosis initiating MOUD and only 3.5% being retained on treatment for a minimum of 6 months. Also, national initiation rates onto MOUD within inpatient substance use disorder (SUD) programs are 18%, which again demonstrates low uptake of MOUD. Supplementing mediation-based treatment with Peer Recovery Support Services (PRSS) may be an effective strategy to encourage MOUD utilization, yet no such evidence-based interventions to specifically improve MOUD initiation and retention currently exist. To address this problem, our ongoing R34 parent grant-funded study (RFA-DA-22-034; Project # 1R34DA057627-01) is developing a new intervention that leverages PRSS to increase MOUD retention in patients living in recovery residences (RRs) and 3.1 residential programs. The parent grant study, however, does not address the aforementioned lagging initiation rates within inpatient SUD treatment programs. To address this gap, our team is conducting this small pilot study to expand the scope of our parent grant clinical trial to improve MOUD initiation across the OUD cascade of care COC. The ongoing parent grant study's goal is to enhance retention for individuals who have already initiated MOUD and are now living in 3.1 residential programs or Recovery Residences (RRs), which are both further downstream in the OUD COC. This small pilot study will expand the scope of the existing parent project by also utilizing PRSS during inpatient SUD treatment, which is more upstream in the COC. The rationale for this expansion of scope pilot study is that by recruiting participants who are more stable and further downstream in the OUD COC, our current parent grant intervention under investigation misses an opportunity to increase MOUD initiation. Preliminary data gathered from our electronic health record at our institution, Maryland Treatment Centers, showed that only 46% of our inpatients diagnosed with OUD initiate MOUD before leaving inpatient SUD treatment, despite the fact that we recommend MOUD as the first-line standard of care. Furthermore, patients with OUD, which included both premature dropouts and successful program completers, left treatment after an average of two weeks (i.e., 14.89 days). Early dropout limits a patient's opportunities to initiate MOUD and/or become stably retained on MOUD. Thus, we will expand the scope of our R34 project to include adapting the existing PRSS intervention for MOUD initiation and obtain pilot data on feasibility in (N = 10-20) patients enrolled in SUD inpatient treatment. We will accomplish this goal by piloting the PRSS intervention for MOUD initiation during the time that remains for the existing R34 parent award. All participants will receive the PRSS intervention for a total of 8 weeks. On important goal of this expanded scope pilot is to explore the feasibility of using PRSS with SUD inpatients. Parent grant Phase 1 qualitative interviews were conducted with stakeholders (N = 16) that included peers (50% of total sample), patients on MOUD (25% of sample), and other professionals working with patients on MOUD (25% of sample) to assess these stakeholders' opinions of the parent grant version of PRSS. Overall, stakeholders found PRSS to be useful and consistent with the tools peers use to help patients adhere to MOUD. The parent grant's rate of recruitment and randomization meets our expected study target goals per month, and demonstrates that the PRSS intervention is feasible with respect to our ability to recruit effectively at Mountain Manor Treatment Center (MMTC), which is under the umbrella of Maryland Treatment Centers and is the study location for this expansion of scope pilot study. We still, however, need to demonstrate the feasibility and acceptability of this expanded scope pilot grant. Unlike the parent grant that only enrolls patients who are already inducted onto MOUD, this expansion of scope proposal will only recruit people who are in SUD inpatient care and who are not currently on MOUD in an effort to get them to initiate MOUD. In summary, the expanded scope aim is as follows. Specific Aim: We will pilot an adapted version of the PRSS parent grant intervention that focuses on improving MOUD initiation in a small uncontrolled pilot sample (N = 10-20) of participants who are being treated further upstream in the OUD COC within an inpatient SUD treatment setting. Hypothesis: We hypothesize that peers and participants will find the modified PRSS intervention to be both acceptable and feasible and that MOUD initiation rates will compare favorably to historical data from our electronic health records. Impact: The research in this expansion of scope pilot study will contribute to NIDA's overarching mission to ameliorate the ongoing opioid epidemic which continues to be a serious problem in the United States. If successful, this pilot work would be an initial step toward developing an intervention that would help opioid users to initiate MOUD, which is the underutilized standard of care for OUD treatment. This research has great potential to directly reduce the impact of the current opioid epidemic, which is a major public health crisis that continues to plague the USA.