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Opioids & SU

The Literature Collection contains over 10,000 references for published and grey literature on the integration of behavioral health and primary care. Learn More

Use the Search feature below to find references for your terms across the entire Literature Collection, or limit your searches by Authors, Keywords, or Titles and by Year, Type, or Topic. View your search results as displayed, or use the options to: Show more references per page; Sort references by Title or Date; and Refine your search criteria. Expand an individual reference to View Details. Full-text access to the literature may be available through a link to PubMed, a DOI, or a URL. References may also be exported for use in bibliographic software (e.g., EndNote, RefWorks, Zotero).

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801
Statewide Trends in Buprenorphine Prescribing in Rural and Nonrural Vermont: Analysis of Population-based Patient Pharmacy Claims
Type: Journal Article
Authors: S. A. Nowak, V. S. Harder, A. C. Villanti, S. H. Heil, S. C. Sigmon
Year: 2023
Topic(s):
Opioids & Substance Use See topic collection
,
Financing & Sustainability See topic collection
,
Healthcare Disparities See topic collection
802
Stepped Care for Opioid Use Disorder Train the Trainer (SCOUTT) initiative: Expanding access to medication treatment for opioid use disorder within Veterans Health Administration facilities
Type: Journal Article
Authors: A. J. Gordon, K. Drexler, E. J. Hawkins, J. Burden, N. K. Codell, A. Mhatre-Owens, M. T. Dungan, H. Hagedorn
Year: 2020
Abstract:

The US is confronted with a rise in opioid use disorder (OUD), opioid misuse, and opioid-associated harms. Medication treatment for opioid use disorder (MOUD)-including methadone, buprenorphine and naltrexone-is the gold standard treatment for OUD. MOUD reduces illicit opioid use, mortality, criminal activity, healthcare costs, and high-risk behaviors. The Veterans Health Administration (VHA) has invested in several national initiatives to encourage access to MOUD treatment. Despite these efforts, by 2017, just over a third of all Veterans diagnosed with OUD received MOUD. VHA OUD specialty care is often concentrated in major hospitals throughout the nation and access to this care can be difficult due to geography or patient choice. Recognizing the urgent need to improve access to MOUD care, in the Spring of 2018, the VHA initiated the Stepped Care for Opioid Use Disorder, Train the Trainer (SCOUTT) Initiative to facilitate access to MOUD in VHA non-SUD care settings. The SCOUTT Initiative's primary goal is to increase MOUD prescribing in VHA primary care, mental health, and pain clinics by training providers working in those settings on how to provide MOUD and to facilitate implementation by providing an ongoing learning collaborative. Thirteen healthcare providers from each of the 18 VHA regional networks across the VHA were invited to implement the SCOUTT Initiative within one facility in each network. We describe the goals and initial activities of the SCOUTT Initiative leading up to a two-day national SCOUTT Initiative conference attended by 246 participants from all 18 regional networks in the VHA. We also discuss subsequent implementation facilitation and evaluation plans for the SCOUTT Initiative. The VHA SCOUTT Initiative could be a model strategy to implement MOUD within large, diverse health care systems.

Topic(s):
Education & Workforce See topic collection
,
Healthcare Disparities See topic collection
,
Opioids & Substance Use See topic collection
803
Steps Physicians Report Taking to Reduce Diversion of Buprenorphine
Type: Journal Article
Authors: Amy Yang, Cynthia L. Arfken, Chris-Ellyn Johanson
Year: 2013
Topic(s):
Opioids & Substance Use See topic collection
,
Education & Workforce See topic collection
804
Stigma associated with medication treatment for young adults with opioid use disorder: a case series
Type: Journal Article
Authors: Scott E. Hadland, Tae Woo Park, Sarah M. Bagley
Year: 2018
Publication Place: England
Abstract:

BACKGROUND: Opioid-related overdose deaths have risen sharply among young adults. Despite this increase, access to evidence-based medication for opioid agonist treatment (OAT) for youth remains low. Among older adults, barriers to OAT include the paucity of buprenorphine-waivered prescribers and low rates of prescribing among waivered physicians. We have increasingly found in our clinical practice significant stigma related to using OAT to treat addiction for young adults. In this series, we describe three cases of young adults who faced significant stigma related to their treatment. CASE PRESENTATIONS: The first case is a young male with a history of significant trauma and a severe opioid use disorder. He started buprenorphine and has found a job, stayed abstinent, and began a healthy relationship. At each step in his recovery, he has faced resistance to taking medication from other treatment providers, directors of sober houses, and his parents. The second case is a young woman who presented to a substance use treatment program after a relapse. She was unable to restart buprenorphine despite our calling to ask that it be restarted. Ultimately, she left against medical advice and was stabilized as an outpatient on buprenorphine. The final case is a young woman who stopped buprenorphine after being told she was "not sober" while attending 12-step group but restarted after conversations with her clinical team. In each case, the patient has continued their medication treatment and are stable. CONCLUSIONS: Opioid-related deaths continue to rise among all age groups, including young adults. Stigma related to medication treatment can be a substantial barrier for many young adult patients but there are concrete steps that providers and communities can take to address this stigma.

Topic(s):
Education & Workforce See topic collection
,
Opioids & Substance Use See topic collection
805
Study design to evaluate a group-based therapy for support persons of adults on buprenorphine/naloxone
Type: Journal Article
Authors: Chan Osilla Karen, Kirsten Becker, Liisa Ecola, Brian Hurley, Jennifer K. Manuel, Allison Ober, Susan M. Paddock, Katherine E. Watkins
Year: 2020
Publication Place: London
Topic(s):
Education & Workforce See topic collection
,
Opioids & Substance Use See topic collection
806
Study design to evaluate a group-based therapy for support persons of adults on buprenorphine/naloxone
Type: Journal Article
Authors: K. C. Osilla, K. Becker, L. Ecola, B. Hurley, J. K. Manuel, A. Ober, S. M. Paddock, K. E. Watkins
Year: 2020
Abstract:

BACKGROUND: Opioid use disorders (OUDs) have devastating effects on individuals, families, and communities. While medication treatments for OUD save lives and are increasingly utilized, rates of treatment dropout are very high. In addition, most existing medication treatments for OUD may often neglect the impact of untreated OUD on relationships and ignore the potential role support persons (SPs) could have on encouraging long-term recovery, which can also impact patient treatment retention. METHODS/DESIGN: The current study adapts Community Reinforcement and Family Training (CRAFT) for use with SPs (family member, spouse or friend) of patients using buprenorphine/naloxone (buprenorphine) in an outpatient community clinic setting. The study will evaluate whether the adapted intervention, also known as integrating support persons into recovery (INSPIRE), is effective in increasing patient retention on buprenorphine when compared to usual care. We will utilize a two-group randomized design where patients starting or restarting buprenorphine will be screened for support person status and recruited with their support person if eligible. Support persons will be randomly assigned to the INSPIRE intervention, which will consist of 10 rolling group sessions led by two facilitators. Patients and SPs will each be assessed at baseline, 3 months post-baseline, and 12 months post-baseline. Patient electronic medical record data will be collected at six and 12 months post-baseline. We will examine mechanisms of intervention effectiveness and also conduct pre/post-implementation surveys with clinic staff to assess issues that would affect sustainability. DISCUSSION: Incorporating the patient's support system may be an important way to improve treatment retention in medication treatments for OUD. If SPs can serve to support patient retention, this study would significantly advance work to help support the delivery of effective treatments that prevent the devastating consequences associated with OUD. Trial registration This study was registered with ClinicalTrials.gov, NCT04239235. Registered 27 January 2020, https://clinicaltrials.gov/ct2/show/NCT04239235 .

Topic(s):
Opioids & Substance Use See topic collection
807
Study protocol of the ESUB-MG cluster randomized trial: a pragmatic trial assessing the implementation of urine drug screening in general practice for buprenorphine maintained patients
Type: Journal Article
Authors: ESUB-MG Study Group
Year: 2016
Publication Place: England
Abstract: BACKGROUND: In addiction care, urine drug screening tests are recommended to assess psychoactive substances use. While intrinsic diagnostic value of these tests is demonstrated, the consequences of carrying out these tests on opiate maintenance treatment (OMT) have not been established. The main objective will be to assess the impact of on-site urine drug screening tests (OS-UDS) in general practice compared to routine medical care on OMT retention at 6 months in opioid-dependent patients initiating buprenorphine. METHODS/DESIGN: The ESUB-MG study uses a pragmatic, cluster randomized controlled trial design. General Practitioners (GPs) regularly managing patients treated with buprenorphine and consenting for participating will be invited to participate. GPs will be randomly assigned to one of two groups for 6 to 24 months: (a) control group (usual care: standard medical strategy for assessing drug use); (b) interventional group (including 1/ a training session on practice and interpretation of OS-UDS; 2/ the supply of OS-UDS at GPs' medical offices; 3/ performing an OS-UDS before the first prescription of buprenorphine). GPs will have to include 1 to 10 patients aged 18 years-old or more, consulting for starting treatment by buprenorphine, not opposed to participate. The primary outcome will be OMT retention at 6 months. DISCUSSION: This randomized interventional trial should bring sufficient level of evidence to assess effectiveness of performing OS-UDS in general practice for patients treated by buprenorphine. Training GPs to drug tests and supplying them in their office should lead to an improvement of opioid-addicted patients' care through helping decision. TRIALS REGISTRATION: NCT02345655 (first registration May 14, 2014).
Topic(s):
Opioids & Substance Use See topic collection
808
Subjective effects of prisoners using buprenorphine for detoxification
Type: Journal Article
Authors: Alexander Johnstone, Tim Duffy, Colin Martin
Year: 2011
Topic(s):
Opioids & Substance Use See topic collection
,
Healthcare Disparities See topic collection
809
Supervised dosing with a long-acting opioid medication in the management of opioid dependence
Type: Journal Article
Authors: R. Saulle, S. Vecchi, L. Gowing
Year: 2017
Publication Place: England
Abstract: BACKGROUND: Opioid dependence (OD) is an increasing clinical and public health problem worldwide. International guidelines recommend opioid substitution treatment (OST), such as methadone and buprenorphine, as first-line medication treatment for OD. A negative aspect of OST is that the medication used can be diverted both through sale on the black market, and the unsanctioned use of medications. Daily supervised administration of medications used in OST has the advantage of reducing the risk of diversion, and may promote therapeutic engagement, potentially enhancing the psychosocial aspect of OST, but costs more and is more restrictive on the client than dispensing for off-site consumption. OBJECTIVES: The objective of this systematic review is to compare the effectiveness of OST with supervised dosing relative to dispensing of medication for off-site consumption. SEARCH METHODS: We searched in Cochrane Drugs and Alcohol Group Specialised Register and Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, Web of Science from inception up to April 2016. Ongoing and unpublished studies were searched via ClinicalTrials.gov (www.clinicaltrials.gov) and World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (http://www.who.int/ictrp/en/).All searches included non-English language literature. We handsearched references on topic-related systematic reviews. SELECTION CRITERIA: Randomised controlled trials (RCTs), controlled clinical trials (CCTs), and prospective controlled cohort studies, involving people who are receiving OST (methadone, buprenorphine) and comparing supervised dosing with dispensing of medication to be consumed away from the dispensing point, usually without supervision. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. MAIN RESULTS: Six studies (four RCTs and two prospective observational cohort studies), involving 7999 participants comparing supervised OST treatment with unsupervised treatment, met the inclusion criteria. The risk of bias was generally moderate across trials, but the results reported on outcomes that we planned to consider were limited. Overall, we judged the quality of the evidence from very low to low for all the outcomes.We found no difference in retention at any duration with supervised compared to unsupervised dosing (RR 0.99, 95% CI 0.88 to 1.12, 716 participants, four trials, low-quality evidence) or in retention in the shortest follow-up period, three months (RR 0.94; 95% CI 0.84 to 1.05; 472 participants, three trials, low-quality evidence). Additional data at 12 months from one observational study found no difference in retention between groups (RR 0.94, 95% CI 0.77 to 1.14; n = 300).There was no difference in abstinence at the end of treatment (self-reported drug use) (67% versus 60%, P = 0.33, 293 participants, one trial, very low-quality evidence); and in diversion of medication (5% versus 2%, 293 participants, one trial, very low-quality evidence).Regarding our secondary outcomes, we did not found a difference in the incidence of adverse effects in the supervised compared to unsupervised control group (RR 0.63; 96% CI 0.10 to 3.86; 363 participants, two trials, very low-quality evidence). Data on severity of dependence were very limited (244 participants, one trial) and showed no difference between the two approaches. Data on deaths were reported in two studies. One trial reported two deaths in the supervised group (low-quality evidence), while in the cohort study all-cause mortality was found lower in regular supervision group (crude mortality rate 0.60 versus 0.81 per 100 person-years), although after adjustment insufficient evidence existed to suggest that regular supervision was protective (mortality rate ratio = 1.23, 95% CI = 0.67 to 2.27).No studies reported pain symptoms, drug craving, aberrant opioid-related behaviours, days of unsanctioned opioid use and overdose. AUTHORS' CONCLUSIONS: Take-home medication strategies are attractive to treatment services due to lower costs, and place less restrictions on clients, but it is unknown whether they may be associated with increased risk of diversion and unsanctioned use of medication. There is uncertainty about the effects of supervised dosing compared with unsupervised medication due to the low and very low quality of the evidence for the primary outcomes of interest for this review. Data on defined secondary outcomes were similarly limited. More research comparing supervised and take-home medication strategies is needed to support decisions on the relative effectiveness of these strategies. The trials should be designed and conducted with high quality and over a longer follow-up period to support comparison of strategies at different stages of treatment. In particular, there is a need for studies assessing in more detail the risk of diversion and safety outcomes of using supervised OST to manage opioid dependence.
Topic(s):
Financing & Sustainability See topic collection
,
Opioids & Substance Use See topic collection
811
Survey of barriers and opportunities for prescribing buprenorphine for opioid use disorder in alabama
Type: Journal Article
Authors: Ishika Patel, Li Li, Haelim Jeong, Justin T. McDaniel, Shanna McIntosh, Ellen Robertson, David L. Albright
Year: 2023
Topic(s):
Education & Workforce See topic collection
812
Syringe service program-based telemedicine linkage to opioid use disorder treatment: protocol for the STAMINA randomized control trial
Type: Journal Article
Authors: D. P. Watson, J. A. Swartz, L. Robison-Taylor, M. E. Mackesy-Amiti, K. Erwin, N. Gastala, A. D. Jimenez, M. D. Staton, S. Messmer
Year: 2021
Abstract:

BACKGROUND: A key strategy for mitigating the current opioid epidemic is expanded access to medications for treating opioid use disorder (MOUD). However, interventions developed to expand MOUD access have limited ability to engage opioid users at higher levels of overdose risk, such as those who inject opioids. This paper describes the study protocol for testing STAMINA (Syringe Service Telemedicine Access for Medication-assisted Intervention through NAvigation), an intervention that engages high-risk opioid users at community-based syringe service programs (SSP) and quickly links them to MOUD using a telemedicine platform. METHODS: This randomized control trial will be conducted at three SSP sites in Chicago. All participants will complete an initial assessment with a provider from a Federally Qualified Health Center who can prescribe or refer MOUD services as appropriate. The control arm will receive standard referral to treatment and the intervention arm will receive immediate telemedicine linkage to the provider and (depending on the type of MOUD prescribed) provided transportation to pick up their induction prescription (for buprenorphine or naltrexone) or attend their intake appointment (for methadone). We aim to recruit a total of 273 participants over two years to provide enough power to detect a difference in our primary outcome of MOUD treatment linkage. Secondary outcomes include treatment engagement, treatment retention, and non-MOUD opioid use. Data will be collected using structured interviews and saliva drug tests delivered at baseline, three months, and six months. Fixed and mixed effects generalized linear regression analyses and survival analysis will be conducted to compare the probabilities of a successful treatment linkage between the two arms, days retained in treatment, and post-baseline opioid and other drug use. DISCUSSION: If successful, STAMINA's telemedicine approach will significantly reduce the amount of time between SSP clients' initial indication of interest in the medication and treatment initiation. Facilitating this process will likely lead to stronger additional treatment- and recovery-oriented outcomes. This study is also timely given the need for more rigorous testing of telemedicine interventions in light of temporary regulatory changes that have occurred during the COVID-19 pandemic. TRIAL REGISTRATION: ClinicalTrials.gov (Clinical Trials ID: NCT04575324 and Protocol Number: 1138-0420). Registered 29 September 2020. The study protocol is also registered on the Open Science Framework (DOI 10.17605/OSF.IO/4853 M).

Topic(s):
Education & Workforce See topic collection
,
HIT & Telehealth See topic collection
,
Opioids & Substance Use See topic collection
813
System-level factors shaping the implementation of "hub and spoke" systems to expand MOUD in rural areas
Type: Journal Article
Authors: C. Snell-Rood, C. Willging, D. Showalter, H. Peters, R. A. Pollini
Year: 2020
Publication Place: United States
Abstract:

Background: Hub and spoke systems (HSS) are increasingly promoted as a systems-level intervention to expand access to medication for opioid use disorders (MOUD), particularly in rural areas with limited treatment options. The HSS model consists of sub-systems in which "hubs" deliver specialized expertise to a regional network of office-based opioid treatment (OBOT) providers in "spokes," who together create a continuum of acute and chronic care. Yet, little is known about system-level factors (e.g., system structure, financing) that influence HSS implementation and sustainability in rural areas. Methods: For this case study, we conducted semi-structured interviews with substance use disorder treatment providers (N = 26) and system-level stakeholders (N = 16) in five rural HSS sub-systems throughout one state. We undertook iterative textual analysis of interview transcripts, identifying and coding themes related to key implementation constructs associated with the Exploration, Preparation, Implementation and Sustainability (EPIS) framework. Results: California policy-makers adopted HSS to expand rural access to opioid treatment programs (OTPs, i.e., providers of methadone and other medications for opioid use disorder). However, stakeholders questioned the model's fit for rural regions featuring few established OTPs that could function as hubs and critiqued its treatment-focused approach, felt to sideline harm reduction service providers. Contracts to serve rural regions were awarded entirely to for-profit methadone providers, contributing to stigma and distrust among many buprenorphine providers whose organizations were later recruited as spokes. While hubs offered financial resources enabling some spokes to expand MOUD, the needs of spokes varied considerably. Relationships between hubs and spokes to facilitate the care continuum under HSS were restricted by limited behavioral health resources and the large distances characterizing rural California. Conclusions: This case study reveals how rural contextual factors such as geography and behavioral healthcare resource availability can dramatically influence differential HSS implementation.

Topic(s):
Education & Workforce See topic collection
,
Healthcare Policy See topic collection
,
Opioids & Substance Use See topic collection
814
Systematic content analysis of patient evaluations of START NOW psychotherapy reveals practical strategies for improving the treatment of opioid use disorder
Type: Journal Article
Authors: A . Y. Truong, B. F. Saway, M. H. Bouzaher, M. N. Rasheed, S. Monjazeb, S. D. Everest, S. L. Giampalmo, D. Hartman, C. Hartman, A. S. Kablinger, R. L. Trestman
Year: 2021
Abstract:

BACKGROUND: Clinical trials provide consistent evidence for buprenorphine's efficacy in treating opioid use disorder (OUD). While the Drug Addiction Treatment Act of 2000 requires physicians to combine medication-assisted treatment (MAT) with behavioral intervention, there is no clear evidence for what form or elements of psychotherapy are most effective when coupled with MAT to treat OUD. This investigation involves focus groups designed to collect patient opinions about a specific psychotherapy, called START NOW, as well as general beliefs about various elements of psychotherapy for treating OUD. Our analysis reveals trends about patient preferences and strategies for improving OUD treatment. METHODS: Subjects included patients enrolled in buprenorphine/naloxone MAT at our institution's office-based opioid treatment program. All subjects participated in a single START NOW group session, which was led by a provider (physician or nurse practitioner trained and standardized in delivering START NOW). Consented subjects participated in satisfaction surveys and audio-recorded focus groups assessing individual beliefs about various elements of psychotherapy for treating OUD. RESULTS: Overall, 38 different focus groups, 92 participation events, and 44 unique subjects participated in 1-to-6 different START NOW session/audio-recorded focus group sessions led by a certified moderator. Demographic data from 36/44 subjects was collected. Seventy-five percent (33/44) completed the START NOW Assessment Protocol, which revealed self-reported behavioral trends. Analysis of all 92 START NOW Satisfaction Questionnaire results suggests that subjects' opinions about START NOW improved with increased participation. Our analysis of audio-recorded focus groups is divided into three subsections: content strategies for new psychotherapies, implementation strategies, and other observations. For example, participants request psychotherapies to target impulsivity and to teach future planning and build positive relationships. CONCLUSIONS: The results of this study may guide implementation of psychotherapy and improve the treatment of OUD, especially as it relates to improving the modified START NOW program for treating OUD. Our study also reveals a favorable outlook of START NOW with increased participation, suggesting that any initial reticence to this program can be overcome to allow for effective implementation.

Topic(s):
Education & Workforce See topic collection
,
Healthcare Policy See topic collection
,
Measures See topic collection
,
Opioids & Substance Use See topic collection
815
Systemic and individual factors in the buprenorphine treatment-seeking process: A qualitative study
Type: Journal Article
Authors: Valerie M. Hewell, Angel R. Vasquez, Inna D. Rivkin
Year: 2017
Topic(s):
Healthcare Policy See topic collection
,
Opioids & Substance Use See topic collection
816
Systemic and individual factors in the buprenorphine treatment-seeking process: a qualitative study
Type: Journal Article
Authors: Valerie M. Hewell, Angel R. Vasquez, Inna D. Rivkin
Year: 2017
Publication Place: England
Abstract:

BACKGROUND: Opioid use is a significant problem in Alaska. Medication-assisted treatment for opioid use, including buprenorphine, reduces withdrawal symptoms and the harm associated with opioid abuse. Understanding consumers' treatment-seeking process is important for addressing barriers to treatment, facilitating effective service utilization, and informing policy. METHODS: To understand treatment-seeking behavior, we examined the attitudes, perceptions, and knowledge of those who would benefit from the medication-assisted treatment (MAT) buprenorphine. Qualitative data from 2 focus groups (each including 4 participants) and 3 in-depth interviews with people who have used or considered using buprenorphine in treatment for an opioid use disorder were analyzed using grounded theory and directed content analysis approaches. RESULTS: Key findings suggest that individual (withdrawal process, individual motivation) and systemic (sociocultural, political, societal values) factors frame the treatment seeking process. Participants' progress on the treatment-seeking road was affected by models of addiction and MAT, which related to facilitators and barriers encountered in seeking treatment (e.g. support, resources, treatment structure). These factors shaped the longer-term road to recovery, which was seen as on ongoing process. CONCLUSIONS: The findings of this study suggest it is crucial for interventionists to take a contextual approach that considers individual and systemic factors involved in opioid addiction, treatment, and recovery. This study highlights ways policy makers and treatment providers can address the barriers consumers face in their treatment-seeking process in order to increase treatment access.

Topic(s):
Education & Workforce See topic collection
,
Opioids & Substance Use See topic collection
818
Teaching residents to prescribe buprenorphine for opioid use disorder: Insights from a community-based residency program
Type: Journal Article
Authors: Layla Cavitt, Joshua St. Louis, Wendy B. Barr, Ryan Dono, Nicholas Weida, Mia Sorcinelli
Year: 2021
Topic(s):
Education & Workforce See topic collection
,
Opioids & Substance Use See topic collection
819
Technical Assistance Publication 30 (TAP 30): Buprenorphine: A guide for nurses
Type: Government Report
Authors: Center for Substance Abuse and Treatment
Year: 2009
Publication Place: Rockville, MD
Topic(s):
Grey Literature See topic collection
,
Opioids & Substance Use See topic collection
,
Education & Workforce See topic collection
Disclaimer:

This grey literature reference is included in the Academy's Literature Collection in keeping with our mission to gather all sources of information on integration. Grey literature is comprised of materials that are not made available through traditional publishing avenues. Often, the information from unpublished resources can be limited and the risk of bias cannot be determined.

820
Technology-Assisted Buprenorphine Treatment in Rural and Nonrural Settings: Two Randomized Clinical Trials
Type: Journal Article
Authors: S. C. Sigmon, K. R. Peck, S. R. Batchelder, G. J. Badger, S. H. Heil, S. T. Higgins
Year: 2023
Abstract:

IMPORTANCE: Expansion of opioid use disorder treatment is needed, particularly in rural communities. OBJECTIVE: To evaluate technology-assisted buprenorphine (TAB) efficacy (1) over a longer period than previously examined, (2) with the addition of overdose education, and (3) among individuals residing in rural communities. DESIGN, SETTING, AND PARTICIPANTS: Two parallel, 24-week randomized clinical trials were conducted at the University of Vermont between February 1, 2018, and June 30, 2022. Participants were adults with untreated opioid use disorder from nonrural (trial 1) or rural (trial 2) communities. These trials are part of a programmatic effort to develop TAB protocols to improve treatment availability in underserved areas. INTERVENTIONS: Within each trial, 50 participants were randomized to TAB or control conditions. Participants in the TAB group completed bimonthly visits to ingest medication and receive take-home doses via a computerized device. They received nightly calls via an interactive voice response (IVR) system, IVR-generated random call-backs, and iPad-delivered HIV, hepatitis C virus (HCV), and overdose education. Control participants received community resource guides and assistance with contacting resources. All participants received harm reduction supplies and completed monthly assessments. MAIN OUTCOMES AND MEASURES: The primary outcome was biochemically verified illicit opioid abstinence across monthly assessments. Secondary outcomes included self-reported opioid use in both groups and abstinence at bimonthly and random call-back visits, treatment adherence, satisfaction, and changes in HIV, HCV, and overdose knowledge among TAB participants. RESULTS: Fifty individuals (mean [SD] age, 40.6 [13.1] years; 28 [56.0%] male) participated in trial 1, and 50 (mean [SD] age, 40.3 [10.8] years; 30 [60.0%] male) participated in trial 2. Participants in the TAB group achieved significantly greater illicit opioid abstinence vs controls at all time points in both trial 1 (85.3% [128 of 150]; 95% CI, 70.7%-93.3%; vs 24.0% [36 of 150]; 95% CI, 13.6%-38.8%) and trial 2 (88.0% [132 of 150]; 95% CI, 72.1%-95.4%; vs 21.3% [32 of 150]; 95% CI, 11.4%-36.5%). High abstinence rates were also observed at TAB participants' bimonthly dosing visits (83.0% [95% CI, 67.0%-92.0%] for trial 1 and 88.0% [95% CI, 71.0%-95.0%] for trial 2). Treatment adherence was favorable and similar between trials (with rates of approximately 99% for buprenorphine administration, 93% for daily IVR calls, and 92% for random call-backs), and 183 of 187 urine samples (97.9%) tested negative for illicit opioids at random call-backs. iPad-delivered education was associated with significant and sustained increases in HIV, HCV, and overdose knowledge. CONCLUSIONS AND RELEVANCE: In these randomized clinical trials of TAB treatment, demonstration of efficacy was extended to a longer duration than previously examined and to patients residing in rural communities. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03420313.

Topic(s):
Opioids & Substance Use See topic collection
,
Healthcare Disparities See topic collection