Study protocol of a randomized controlled trial comparing two linkage models for HIV prevention and treatment in justice-involved persons.

BACKGROUND: Persons involved in the justice system are at high risk for HIV and drug overdose upon release to the community. This manuscript describes a randomized controlled trial of two evidence-based linkage interventions for provision of HIV prevention and treatment and substance use disorder (SUD) services in four high risk communities to assess which is more effective at addressing these needs upon reentry to the community from the justice system. METHODS: This is a 5-year hybrid type 1 effectiveness-implementation randomized controlled trial that compares two models (Patient Navigation [PN] or Mobile Health Unit [MHU] service delivery) of linking justice-involved individuals to the continuum of community-based HIV and SUD prevention and treatment service cascades of care. A total of 864 justice-involved individuals in four US communities with pre-arrest histories of opioid and/or stimulant use who are living with or at-risk of HIV will be randomized to receive either: (a) PN, wherein patient navigators will link study participants to community-based service providers; or (b) services delivered via an MHU, wherein study participants will be provided integrated HIV prevention/ treatment services and SUD services. The six-month post-release intervention will focus on access to pre-exposure prophylaxis (PrEP) for those without HIV and antiretroviral treatment (ART) for people living with HIV (PLH). Secondary outcomes will examine the continuum of PrEP and HIV care, including: HIV viral load, PrEP/ ART adherence; HIV risk behaviors; HCV testing and linkage to treatment; and sexually transmitted infection incidence and treatment. Additionally, opioid and other substance use disorder diagnoses, prescription, receipt, and retention on medication for opioid use disorder; opioid and stimulant use; and overdose will also be assessed. Primary implementation outcomes include feasibility, acceptability, sustainability, and costs required to implement and sustain the approaches as well as to scale-up in additional communities. DISCUSSION: Results from this project will help inform future methods of delivery of prevention, testing, and treatment of HIV, HCV, substance use disorders (particularly for opioids and stimulants), and sexually transmitted infections for justice-involved individuals in the community. TRIAL REGISTRATION: Clincialtrials.gov NCT05286879 March 18, 2022.

Gender differences among persons entering medication treatment for opioid use disorder in the community.

BACKGROUND AND OBJECTIVES: We evaluated gender differences among persons initiating medications for opioid use disorder (MOUD). METHODS: Analyses of baseline assessments for a study evaluating the impact of MOUD on outcomes included: demographics, DSM-5 diagnoses, depression severity, quality of life (QoL), and medication history (N = 125). RESULTS: When compared to men, women had a greater prevalence of generalized anxiety and posttraumatic stress disorders; and worse psychological QoL. Women were less likely to be prescribed psychiatric medications. DISCUSSION AND CONCLUSIONS: Women may benefit from tailored multidisciplinary programs with MOUD. SCIENTIFIC SIGNIFICANCE: This study identified that women with OUD seeking MOUD in the community had greater sedative hypnotic nonprescribed medication use and psychiatric comorbidity than men, all of which can contribute to poorer retention on MOUD and higher risk of morbidity and mortality. Thus, concurrent psychiatric disorder screening and treatment integrated with MOUD may improve retention on MOUD, opioid relapse and overdose for women.

Gender differences among criminal justice-involved persons living with HIV interested in extended-release naltrexone treatment.

Background: Previous research has shown gender differences with respect to entry into medication treatment of substance use disorders (SUDs), yet few have examined gender differences among participants consented to be treated with extended-release naltrexone (XR-NTX). Understanding gender differences is critical to developing interventions to overcome barriers to initiation of and retention on medication treatment for SUDs. Methods: Data from two double-blind placebo-controlled trials of XR-NTX among persons with HIV and alcohol or opioid use disorders leaving the criminal justice system (CJS) were analyzed for gender differences among clinical characteristics, mental health, drug use severity, and other domains. The study that recruited persons with alcohol use disorder (AUD) was conducted from September 2010-February 2016 at two sites in Connecticut (CT), and the opioid use disorder (OUD) study was conducted from September 2010-March 2016 at three sites in CT and one site in Massachusetts. Results: Baseline data were analyzed from 193 participants consented to be randomized to XR-NTX or placebo; 40 women and 153 men. Women were younger, had worse mental health severity, and were more likely to be diagnosed with cocaine use disorder. There were no statistical differences between men and women in the prescription of antiretroviral therapy (ART) or ART adherence. Conclusions: Women had greater mental health severity and a higher prevalence of cocaine use as compared to men, both of which are known to be barriers to engagement and retention on medication treatment for alcohol and opioid use disorders. For women with CJS involvement and living with HIV and SUDs, understanding factors that may affect initiation and retention on medication treatment of SUDs are necessary to improve treatment outcomes in women.

A Literature Review Examining Primary Outcomes of Medication Treatment Studies for Opioid Use Disorder: What Outcome Should Be Used to Measure Opioid Treatment Success?

BACKGROUND AND OBJECTIVES: Medications for opioid use disorder (MOUD) reduce opioid use and overdose; however, MOUD clinical trials have used varying primary outcomes to document treatment success. We conducted a literature review to assess and critically examine the methodologies used in MOUD treatment studies. METHODS: Published studies in English that examined MOUD (buprenorphine, methadone, or extended-release naltrexone) were included (N = 20). The methods and frequencies of measuring primary opioid outcomes, including urine drug tests (UDTs) and self-report of opioid use were compared among studies. RESULTS: A total of 20 studies fit the inclusion criteria. Each study assessed opioid use; only 12 had opioid use as a primary outcome. Other primary outcomes included retention in treatment (N = 6), and two had other primary outcomes (death and opioid withdrawal symptoms). Opioid use was assessed through both self-report and UDTs in 15 studies. Two studies did not use UDTs. Differences were found in the methods used for how opioid use, retention in treatment, self-report of opioid use, and UDTs were measured. DISCUSSION AND CONCLUSIONS: The different primary outcomes used and operational definitions in each study make comparisons between studies difficult. The use of both self-report and UDTs for opioid use has several advantages, and if possible, researchers should use both measures. SCIENTIFIC SIGNIFICANCE: This is the first review critically examining outcome measures from MOUD treatment studies. Creating a standard for opioid treatment outcomes in MOUD studies will allow for generalizable results that can inform both researchers and clinicians to better care for those with OUD. (Am J Addict 2020;00:00-00).

Inpatient Low-dose Transitions From Full Agonist Opioids Including Methadone Onto Long-acting Depot Buprenorphine: Case Series From a Multicenter Clinical Trial.

OBJECTIVES: Persons with opioid use disorder (OUD) suffer disproportionately from morbidity and mortality related to serious addiction-related infections requiring hospitalization. Long-acting buprenorphine (LAB) is an underused medication for OUD that may facilitate linkage to care and treatment retention when administered before hospital discharge. Transition onto buprenorphine in the inpatient setting is often complicated by pain, active infection management, potential surgical interventions, and risk of opioid withdrawal in transition from full agonists to a partial agonist. METHODS: The COMMIT Trial is a randomized controlled trial evaluating LAB administered by infectious disease physicians and hospitalists compared with treatment as usual for persons with OUD hospitalized with infections. We report a case series of participants on full agonist opioids including methadone who were transitioned to sublingual buprenorphine using low-dose ( microdosing ) strategies followed by LAB injection. RESULTS: Seven participants with current opioid use disorder and life-threatening infections, all with significant concurrent pain and many requiring surgical intervention, underwent low-dose transitions starting at buccal buprenorphine doses ranging from 225 µg to 300 µg 3 times a day on the first day. All were well tolerated with average time to LAB injection of 7.5 days (range, 5-10 days). CONCLUSIONS: Inpatient low-dose buprenorphine transition from full agonist opioids including methadone onto LAB is feasible even in those with complex hospitalizations for concurrent infections and/or surgery. This strategy facilitates dosing of LAB before hospital discharge when risk of opioid relapse and overdose are significant.

Design and methods of a multi-site randomized controlled trial of an integrated care model of long-acting injectable buprenorphine with infectious disease treatment among persons hospitalized with infections and opioid use disorder.

BACKGROUND: Hospitalization with co-occurring opioid use disorder (OUD) and infections presents a critical time to intervene to improve outcomes for these intertwined epidemics that are typically managed separately. A surge in life-threatening infectious diseases associated with injection drug use, including bacterial and fungal infections, HIV, and HCV accounts for substantial healthcare utilization, morbidity, and mortality. Infectious Disease (ID) specialists manage severe infections that require hospitalization and are a logical resource to engage patients in medication treatment for OUD (MOUD). An injectable long-acting monthly formulation of buprenorphine (LAB) has a potential advantage for initiating MOUD within hospital settings and bridging to treatment after discharge. METHODS: A randomized multi-site trial tests a new model of care (ID/LAB) in which OUD and infections are managed by ID specialists and hospitalists using LAB coupled with referrals to community resources for long-term MOUD. A sample of 200 adults admitted to three U.S. hospitals for OUD and infections are randomly assigned 1:1 to ID/LAB or treatment as usual (TAU). The primary outcome measure is the proportion of patients enrolled in effective MOUD at 12 weeks after randomization. Secondary outcomes include relapse to opioid use, adherence to infectious disease treatment, infection morbidity and mortality, and drug overdose. RESULTS: We describe the design, procedures, statistical analysis, and early implementation issues of this randomized trial. CONCLUSIONS: Study findings will provide insight into the feasibility and effectiveness of integrated treatment of OUD and serious infections and have the potential to reduce morbidity and mortality in this vulnerable population.