Addiction Science & Clinical Practice最新文献

{"title":"Readiness to implement contingency management to promote PrEP initiation and adherence among people who inject drugs: results from a multi-site implementation survey.","authors":"Eleanor Pickering, Adam Viera, Minhee L Sung, Daniel Davidson, Genie Bailey, Marianne Buchelli, Mark Jenkins, Jennifer Kolakowski, Leah Maier, E Jennifer Edelman, Carla J Rash","doi":"10.1186/s13722-024-00503-4","DOIUrl":"10.1186/s13722-024-00503-4","url":null,"abstract":"<p><strong>Background: </strong>Contingency management (CM), an incentive-based intervention to encourage target behaviors, effectively promotes medication adherence. However, efforts to extend CM to HIV pre-exposure prophylaxis (PrEP) have been lacking. As part of a randomized clinical trial to promote HIV Prevention among people who inject drugs (PWID), we examined the readiness of staff in community-based organizations serving PWID to implement CM for PrEP uptake and adherence in this population.</p><p><strong>Methods: </strong>From April to August 2022, we conducted a survey of staff from four community-based organizations providing HIV testing, harm reduction, and outreach services in the northeastern United States. We assessed knowledge and attitudes regarding PrEP for PWID on five-point Likert scales (e.g., Poor to Excellent, Not at all to Extremely). Using a modified version of the Contingency Management Beliefs Questionnaire, we assessed the degree to which attitudes about CM for HIV prevention influenced interest in its adoption on a scale from \"1-No influence at all\" to \"5-Very strong influence\". We explored endorsement patterns, along with average values of individual items and subscale scores.</p><p><strong>Results: </strong>Among 271 staff invitations, 123 (45.4%) responded. The majority (88.6%) of respondents reported prior PrEP awareness, with a mean self-rated knowledge of 2.98 out of 5 (SD = 1.1). Attitudes towards PrEP, including its relevance to and importance for clients (both means = 4.3), efficacy (mean = 4.5), and safety (mean = 4.2), were positive. Items related to practicality and confidence in providing PrEP-related care had relatively lower ratings. Respondents endorsed influential generalized (mean = 2.1) and training-related (mean = 2.5) CM implementation barriers less frequently than positive attitudes towards CM (mean = 3.6). Staff favored adding CM to existing services (mean = 3.8), and highly endorsed it as \"useful for targeting HIV prevention with PrEP\" (mean = 3.7).</p><p><strong>Conclusions: </strong>Respondents generally supported the use of CM to promote HIV prevention among PWID and favored adding it to their existing services. Though respondents understood the value of both PrEP and CM to support HIV prevention activities, findings corroborate research citing relative lack of knowledge and confidence regarding PrEP management among clients, potentially detracting from implementation readiness.</p><p><strong>Trial registration number: </strong>NCT04738825.</p>","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":"19 1","pages":"97"},"PeriodicalIF":3.7,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11665208/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877791","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Organization of primary care and early MOUD discontinuation.","authors":"Rebecca Arden Harris, Matthew Kearney, Shimrit Keddem, Tara Calderbank, Liza Tomczuk, Justin Clapp, Jeanmarie Perrone, Henry R Kranzler, Judith A Long, David S Mandell","doi":"10.1186/s13722-024-00527-w","DOIUrl":"10.1186/s13722-024-00527-w","url":null,"abstract":"","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":"19 1","pages":"96"},"PeriodicalIF":3.7,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11658460/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142866454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Medications for opioid use disorders among incarcerated persons and those in the community supervision setting: exploration of implementation issues with key stakeholders.","authors":"Augustine W Kang, Amelia Bailey, Anthony Surace, Lynda Stein, Damaris Rohsenow, Rosemarie A Martin","doi":"10.1186/s13722-024-00528-9","DOIUrl":"10.1186/s13722-024-00528-9","url":null,"abstract":"<p><strong>Introduction: </strong>Receipt of medications for opioid use disorder (MOUD) critically reduces opioid-related mortality during the post-incarceration period. Optimal provision of this care to individuals on community supervision (i.e., probation) requires an understanding of this unique and complex system at the local level.</p><p><strong>Methods: </strong>We conducted in-depth individual interviews with key treatment providers and probation staff (n = 10) involved with the provision of MOUD to individuals on community supervision in the Northeast. Interviews explored perspectives on the provision of MOUD and support services during the community supervision period. Thematic analysis was conducted to describe inductive and deductive codes, subcodes, and themes.</p><p><strong>Results: </strong>Stakeholders shared diverse attitudes about the benefits and drawbacks of MOUD utilization. The provision of MOUD during the community supervision period was perceived to be influenced by both treatment and probation organizational characteristics, including the structures and values of the agencies. As such, the specific context of the community supervision setting facilitated and impeded MOUD delivery. Persistent challenges to enhancing MOUD delivery to this population remain including widespread MOUD stigma, inter-agency communication issues, and structural barriers to healthcare (i.e., transportation, finances).</p><p><strong>Conclusions: </strong>There are opportunities to enhance access to evidence-based OUD treatment for persons on community supervision by engaging probation agencies and community treatment staff in systems change.</p>","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":"19 1","pages":"95"},"PeriodicalIF":3.7,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11653911/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142856853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Centering autonomy and choice to support oral PrEP utilization among people who inject drugs: qualitative lessons from HPTN 094 INTEGRA.","authors":"Amaya Perez-Brumer, Rose Schmidt, Rebecca Kennedy, Jordan E Lake, Yolanda R Villarreal, Sydney Bornstein, Irene Kuo, Omar Nieto, Julie Franks, Cecile Denis, Nabila El-Bassel, Steve Shoptaw, Peter Davidson, Laramie R Smith","doi":"10.1186/s13722-024-00520-3","DOIUrl":"10.1186/s13722-024-00520-3","url":null,"abstract":"<p><strong>Background: </strong>Oral Pre-exposure prophylaxis (PrEP) is effective in preventing HIV transmission. However, despite high rates of HIV risk behaviors among people who inject drugs (PWID), this population remains underserved by current HIV prevention efforts in the United States. To address this challenge, we conducted an in-depth exploration of perspectives on using oral PrEP among PWID engaged in the HIV Prevention Trials Network (HPTN) 094 INTEGRA Study.</p><p><strong>Methods: </strong>Guided by the Practical, Robust, Implementation, and Sustainability Model (PRISM), our qualitative study drew on semi-structured interviews conducted as part of the embedded implementation science evaluation of HPTN 094 INTEGRA. Seventy-seven PWID participants from five sites across New York City, Houston, Los Angeles, Philadelphia, and Washington DC were interviewed to assess intervention delivery, care access, and engagement sustainability. Audio files were transcribed verbatim and analyzed via an inductive and deductive thematic approach.</p><p><strong>Results: </strong>Most participants (n = 46, 59.7%) discussed oral PrEP during their interview, though not directly prompted. Participants discussing PrEP had a mean age of 41.6 years and were predominantly white (54.3%) and cisgender men (60.9%). Among these, 15 participants described using PrEP. All participants had facilitated access to oral PrEP. Yet, the choice to use PrEP was influenced by personal risk perceptions, (mis)information about PrEP, and external factors (i.e. housing, financial security), which, for some, limited the autonomy to use PrEP. Two key themes emerged among participants using PrEP: ease of access and perceptions of high HIV risk. Those not using PrEP described two themes: low risk perception and prioritizing more urgent needs. Among participants not using PrEP a subgroup commonly described ambivalent interest, PrEP knowledge gaps, and PrEP readiness (i.e., contemplation).</p><p><strong>Conclusions: </strong>Qualitative findings highlight that facilitated PrEP access was insufficient to motivate use for many participants. Rather, PrEP decision-making process (i.e., choice) was linked to risk perception and individuals' capability to leverage PrEP as a resource based on their circumstances (i.e., autonomy). Participants' descriptions of the centrality of choice and autonomy for PrEP use underscore that ease of access is a necessary pre-condition, but person-centered interventions should also address housing, financial stability, and urgent medical conditions to promote PrEP utilization among PWID.</p><p><strong>Clinical trial registration: </strong>NCT04804027.</p>","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":"19 1","pages":"92"},"PeriodicalIF":3.7,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11653907/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142856832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Grayken Lessons: a patient who developed opioid use disorder after traumatic brain injury.","authors":"Gabriela Reed, Hansel Lugo, Rachel Sayko Adams, Alexander Y Walley","doi":"10.1186/s13722-024-00525-y","DOIUrl":"10.1186/s13722-024-00525-y","url":null,"abstract":"<p><strong>Background: </strong>Traumatic brain injury (TBI) is common in people with substance use disorders (SUDs). TBI often results in cognitive deficits which can affect the clinical course of SUD.</p><p><strong>Case presentation: </strong>Here we present the case of a 34-year-old Spanish-speaking man with severe opioid use disorder and two prior TBIs affecting his cognitive abilities. He was linked to outpatient addiction specialty care at a community health center. After identification of his TBI history, his care team, which included a language-concordant physician and peer recovery coach, worked to develop a treatment plan that accounted for his unique cognitive deficits and behavioral challenges. He was also connected with community resources including a rehabilitation program designed for people with TBI. These individualized aspects of treatment helped to better engage and retain the patient in quality care for his SUD.</p><p><strong>Conclusions: </strong>By identifying TBI history in people with SUDs, the treatment plan can be tailored to accommodate TBI-related deficits. An effective care plan should incorporate not only medical providers, but also resources such as peer recovery supports and TBI-focused rehabilitation programs when and where they are available, with an emphasis on improving functional capacity.</p>","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":"19 1","pages":"94"},"PeriodicalIF":3.7,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11654155/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142856838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Innovations to the ECHO model to enhance reach and network-building among addiction clinicians in Western Canada.","authors":"Samantha Robinson, Isabella Brohman, Jenna van Draanen, Rivka Kushner, Nadia Fairbairn, Stephanie Glegg","doi":"10.1186/s13722-024-00524-z","DOIUrl":"10.1186/s13722-024-00524-z","url":null,"abstract":"<p><strong>Background: </strong>Building capacity for evidence-based treatment and support for people with substance use disorders (SUD) is an urgent priority in the context of the toxic drug poisoning crisis. We implemented the first substance use-focused Project Extension for Community Healthcare Outcomes (ECHO) in Western Canada for health care providers, to enhance their clinical addiction skills and knowledge, facilitate practice change, and foster a supportive community of practice. The aims of this article are to describe our innovations to the Project ECHO model in British Columbia (BC) and Yukon, and present key program outcomes.</p><p><strong>Methods: </strong>A pragmatic multi-methods program evaluation employed observational records of BC ECHO on Substance Use session attendance, cross-sectional and longitudinal participant surveys, and qualitative interviews with participants to assess satisfaction, relevance, and preparation to use evidence-based approaches, practice change intentions, and actual behaviours.</p><p><strong>Results: </strong>The 52 ECHO sessions (from June 2019 to July 2022) attracted 2134 unique registrants with 5089 attendances (mean 124/session), 2132 newsletter subscribers, and 5842 podcast downloads. The evaluation included 844 post-session survey respondents and 53 interview participants. The program included ECHO sessions with rolling attendance; widely accessed supplemental formats (e.g., newsletter, podcast, clinical tools, archived presentation recordings); variable, regional hub representation; and evidence-based content developed by medical writers. These features contributed to broad geographic and discipline reach, high-quality program content, and high mean session satisfaction ratings (4.2/5). Key qualitative themes emerged, related to knowledge and skill acquisition, gaining confidence in providing SUD care, facilitating shared decision-making, increasing compassion for patients, consolidating learning and applying it to practice, and reducing isolation through expanded networks.</p><p><strong>Conclusions: </strong>The ECHO model is an effective way to improve capacity in SUD care for physicians and nurse practitioners, while offering benefits for interprofessional attendees. Our findings can inform innovations in other ECHO programs to enhance reach, engagement, and impact.</p>","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":"19 1","pages":"93"},"PeriodicalIF":3.7,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11654416/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142856851","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Inpatient detoxification for alcohol and other drug use: qualitative study of patients' accounts of their relationships with staff.","authors":"Joanne Neale, Beth Cairns, Kevin Gardiner, Wulf Livingston, Trevor McCarthy, Andrew Perkins","doi":"10.1186/s13722-024-00523-0","DOIUrl":"https://doi.org/10.1186/s13722-024-00523-0","url":null,"abstract":"<p><strong>Background: </strong>The therapeutic alliance is an important predictor of treatment outcomes but people who use alcohol and other drugs report mixed views of treatment providers. We analysed patients' accounts of inpatient detoxification staff to ascertain whether, and if so how, relationships with them, and thus the therapeutic alliance, might be improved.</p><p><strong>Methods: </strong>Semi-structured qualitative interviews were conducted (in 2022/2023) with 20 people (14 males; 6 females) who had just completed inpatient detoxification in sixteen different facilities. Interviews were part of a larger longitudinal qualitative evaluation of an initiative to increase inpatient detoxification capacity across England.</p><p><strong>Results: </strong>Patients described how treatment was delivered by professionals with diverse roles. They rated staff highly and appreciated their personal qualities; the standard of medical care and non-medical services they provided; their willingness to provide privacy, freedom and choice; the support given at key points in the treatment journey; and the positive impact staff relationships had on their substance use and lives more generally. Criticisms of staff were infrequent, mostly related to specific individuals or events, and potentially more common when detoxification occurred within general hospitals rather than within specialist services.</p><p><strong>Conclusions: </strong>Patients' accounts of staff in this study were more positive than documented in previous literature. However, the characteristics that patients appreciated (and disliked) were consistent with earlier research. There was scope to improve in some services and patient groups not interviewed may have held more negative views of staff. Overall, the holistic and patient-centred approach that staff adopted, and patients valued, appears to contribute to a good therapeutic alliance.</p>","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":"19 1","pages":"89"},"PeriodicalIF":3.7,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11610126/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142774581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacy-based preventive services for opioid use disorder: a survey of U.S. pharmacists.","authors":"Li-Tzy Wu, Jacquie King, Kathryn Hefner, Mark Schactman, William John, Nicholas Hagemeier, Abigail G Matthews, Nathaniel Levitt, Paolo Mannelli","doi":"10.1186/s13722-024-00519-w","DOIUrl":"https://doi.org/10.1186/s13722-024-00519-w","url":null,"abstract":"<p><strong>Background: </strong>Pharmacists play a key role in combating the opioid-related overdose epidemic in the United States (US), but little is known about their experience and willingness to deliver preventive services for opioid use disorder (OUD).</p><p><strong>Aims: </strong>This study seeks to identify correlates of pharmacists' concerns about drug use problems (prescription drug misuse/use disorder and illicit drug use/use disorder) as well as their practice experience delivering preventive services for OUD (e.g., asked about opioid use, provided advice, made a referral) and willingness to provide services to patients with drug use problems.</p><p><strong>Design: </strong>An online survey of licensed US pharmacists was conducted. Participants were recruited from Community Pharmacy Enhanced Services Networks (CPESN) and state pharmacist associations (N = 1146).</p><p><strong>Findings: </strong>Overall, 75% of surveyed pharmacists indicated having concerns about opioid use problems, and 62% had concerns about non-opioid drug use problems at their pharmacies. Pharmacists who were White, practiced at a rural location, worked at a chain pharmacy, had not received opioid-related training in the past year, or practiced screening patients for opioid use had elevated odds of perceiving concerns about opioid use problems in their practice settings. Pharmacists who were White, practiced at a rural location, or had not received opioid-related training in the past year had elevated odds of perceiving concerns about non-opioid (illicit) drug use problems. Being male, being White, or having received opioid-related training were associated with increased odds of screening patients for opioid use problems. Being White, having practiced at a rural location (vs. an urban location), being a pharmacy owner/manager, or having received opioid-related training were associated with increased odds of delivering opioid-related advice/intervention. Being male or having received opioid-related training were associated with increased odds of making a referral to OUD treatment. Finally, being male, being White, having practiced pharmacy services for under 6 years, having received opioid-related training for 2 h in the past year, or having performed OUD-related preventive services (asked about opioid use, provided advice, or made a referral) were associated with increased levels of commitment/readiness for providing care to patients with drug use problems.</p><p><strong>Conclusions: </strong>The overall findings highlight pharmacists' involvement with OUD preventive services. It is critical to promote opioid-related preventive service training for pharmacists and provide incentives/tools to help initiate a structured practice of delivering such preventive services.</p>","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":"19 1","pages":"88"},"PeriodicalIF":3.7,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11610115/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142774630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regaining control over alcohol intake but not abstinence on disulfiram medication, as a harm reduction approach: 2 case reports.","authors":"Max Schallenberg, Maximilian Pilhatsch, Johannes Petzold, Diana Vogel-Blaschka, Ulrich S Zimmermann, Maik Spreer","doi":"10.1186/s13722-024-00522-1","DOIUrl":"10.1186/s13722-024-00522-1","url":null,"abstract":"<p><strong>Background: </strong>Alcohol use disorder (AUD) poses severe health risks, yet many affected individuals opt out of complete abstinence. Therefore, harm reduction strategies have become more prominent in treatment guidelines for AUD. Our two case reports illustrate how disulfiram, initially intended to enforce abstinence, was repurposed to support reduced drinking.</p><p><strong>Case presentations: </strong>A 41-year-old patient with a history of severe AUD successfully reduced his alcohol consumption to a low-risk level by leveraging the effects of the disulfiram-alcohol aversive reaction. Another patient, a 63-year-old woman with long histories of AUD and major depressive disorder, experienced fewer depressive episodes and hospitalizations with disulfiram therapy despite periodically intentional discontinuation of medication.</p><p><strong>Conclusion: </strong>Individualized treatment strategies are critical in optimizing outcomes for patients with AUD. Continuous disulfiram therapy, despite its limitations in directly reducing alcohol intake, might offer a new avenue for harm reduction in exceptional cases even if alcohol consumption continues. The cases suggest that maintaining therapy, aiming at reduced drinking, can enhance the therapeutic alliance and help manage comorbid conditions. Regular medical monitoring is essential for safety and efficacy, warranting further study of possible long-term consequences and psychotropic effects of elevated acetaldehyde levels related to the disulfiram-alcohol interaction.</p>","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":"19 1","pages":"90"},"PeriodicalIF":3.7,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11610367/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142774707","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exemplar Hospital Initiation Trial to Enhance Treatment Engagement (EXHIT ENTRE): protocol for CTN-0098 an open-label randomized comparative effectiveness trial of extended-release buprenorphine versus treatment as usual on post-hospital treatment engagement for hospitalized patients with opioid use disorder.","authors":"Gavin Bart, Kelly S Barth, Paulette Baukol, Eva Enns, Udi E Ghitza, Jacklyn Harris, Eve Jelstrom, Jane M Liebschutz, Kara M Magane, Delia Voronca, Zoe M Weinstein, P Todd Korthuis","doi":"10.1186/s13722-024-00510-5","DOIUrl":"10.1186/s13722-024-00510-5","url":null,"abstract":"<p><strong>Background: </strong>Hospitalizations involving opioid use disorder (OUD) are increasing. Addiction consultation services (ACS) initiate medications for opioid use disorder (MOUD) in hospital settings and arrange post-hospital follow-up for ongoing MOUD care. Engagement in MOUD following hospital discharge is hampered by challenges in timely access to MOUD. This protocol describes an open-label randomized comparative effectiveness trial comparing ACS treatment as usual (TAU) to a single injection of a 28-day formulation extended-release buprenorphine (XR-BUP) on MOUD engagement 34-days following hospital discharge.</p><p><strong>Methods: </strong>Six U.S. hospitals with ACS capable of prescribing all MOUD (i.e., methadone, buprenorphine, and extended-release naltrexone) recruit and randomize hospitalized patients with OUD who have not been on MOUD in the fourteen days prior to hospitalization. TAU may consist of any MOUD other than XR-BUP. Participants randomized to XR-BUP may receive any MOUD throughout their hospital stay and receive a 28-day XR-BUP injection within 72-hours of anticipated hospital discharge. There is no intervention beyond hospital stay. Participants are followed 34-, 90-, and 180-days following hospital discharge. The primary outcome is engagement in any MOUD 34-days following hospital discharge, which we hypothesize will be greater in the XR-BUP group. Randomizing 342 participants (171 per arm) provides 90% power to detect difference in the primary outcome between groups with an odds ratio of 2.1. Safety, secondary, and exploratory outcomes include: adverse events, MOUD engagement on days 90 and 180, opioid positive urine drug tests, self-reported drug use, hospital readmissions and emergency department visits, use of non-opioid drugs, fatal and non-fatal opioid overdose, all-cause mortality, quality of life, and cost-effectiveness. Data are analyzed by intention-to-treat, with pre-planned per-protocol and other secondary analyses that examine gender as an effect modifier, differences between groups, and impact of missingness.</p><p><strong>Discussion: </strong>Engagement in MOUD care following hospitalization in individuals with OUD is low. This randomized comparative effectiveness trial can inform hospital ACS in medication selection to improve MOUD engagement 34-days following hospital discharge.</p><p><strong>Trial registration: </strong>NCT04345718.</p>","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":"19 1","pages":"91"},"PeriodicalIF":3.7,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11610182/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142774134","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}