Project description:BackgroundRelapse rates during opioid use disorder (OUD) treatment remain unacceptably high. It is possible that optimally matching patients with medication type would reduce risk of relapse. Our objective was to learn a rule by which to assign type of medication for OUD to reduce risk of relapse, and to estimate the extent to which risk of relapse would be reduced if such a rule were used.MethodsThis was a secondary analysis of an open-label randomized controlled, 24-week comparative effectiveness trial of injection extended-release naltrexone (XR-NTX), delivered approximately every 28 days, or daily sublingual buprenorphine-naloxone (BUP-NX) for treating OUD, 2014-2017 (N = 570). Outcome was a binary indicator of relapse to regular opioid use during the 24 weeks of outpatient treatment.ResultsWe found that applying an estimated individualized treatment rule-i.e., a rule that assigns patients with OUD to either XR-NTX or BUP-NX based on their individual characteristics in such a way that risk of relapse is minimized-would reduce risk of relapse by 24 weeks by 12% compared to randomly assigned treatment.ConclusionsThe number-needed-to-treat with the estimated treatment rule to prevent a single relapse is 14. A simpler, alternative estimated rule in which homeless participants would be treated with XR-NTX and stably housed participants would be treated with BUP-NX performed similarly. These results provide an estimate of the amount by which a relatively simple change in clinical practice could be expected to improve prevention of OUD relapse.
Project description:ImportanceGabapentin prescriptions have drastically increased in the US due to off-label prescribing in settings such as opioid use disorder (OUD) treatment to manage a range of comorbid conditions and withdrawal symptoms, despite a lack of evidence.ObjectiveTo assess the purpose and associated risks of off-label gabapentin use in OUD treatment.Design, setting, and participantsThis retrospective recurrent-event case-control study with a crossover design used administrative claims data from MarketScan Commercial and Multi-State Medicaid databases from January 1, 2006, to December 31, 2016. Individuals aged 12 to 64 years with an OUD diagnosis and filling buprenorphine prescriptions were included in the primary analysis conducted from July 1, 2022, through June 1, 2023. Unit of observation was the person-day.ExposuresDays covered by filled gabapentin prescriptions.Main outcomes and measuresPrimary outcomes were receipt of gabapentin in the 90 days after initiation of buprenorphine treatment and drug-related poisoning. Drug-related poisonings were defined using codes from International Classification of Diseases, Ninth Revision, and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision.ResultsA total of 109 407 patients were included in the analysis (mean [SD] age, 34.0 [11.2] years; 60 112 [54.9%] male). Among the 29 967 patients with Medicaid coverage, 299 (1.0%) were Hispanic, 1330 (4.4%) were non-Hispanic Black, 23 112 (77.1%) were non-Hispanic White, and 3399 (11.3%) were other. Gabapentin was significantly less likely to be prescribed to Black or Hispanic patients, and more likely to be prescribed to female patients, those with co-occurring substance use or mood disorders, and those with comorbid physical conditions such as neuropathic pain. Nearly one-third of persons who received gabapentin (4336 [31.1%]) had at least 1 drug-related poisoning after initiating buprenorphine treatment, compared with 13 856 (14.5%) among persons who did not receive gabapentin. Adjusted analyses showed that days of gabapentin use were not associated with hospitalization for drug-related poisoning (odds ratio, 0.98 [95% CI, 0.85-1.13]). Drug-related poisoning risks did not vary based on dosage.Conclusions and relevanceGabapentin is prescribed in the context of a myriad of comorbid conditions. Even though persons receiving gabapentin are more likely to have admissions for drug-related poisoning, these data suggest that gabapentin is not associated with an increased risk of drug-related poisoning alongside buprenorphine in adjusted analyses. More data on the safety profile of gabapentin in OUD settings are needed.
Project description:The severity of the ongoing opioid crisis, recently exacerbated by the COVID-19 pandemic, emphasizes the importance for individuals suffering from opioid use disorder (OUD) to have access to and receive efficacious, evidence-based treatments. Optimal treatment of OUD should aim at blocking the effects of illicit opioids while controlling opioid craving and withdrawal to facilitate abstinence from opioid use and promote recovery. The present work analyses the relationship between buprenorphine plasma exposure and clinical efficacy in participants with moderate to severe OUD using data from two clinical studies (39 and 504 participants). Leveraging data from placebo-controlled measures assessing opioid blockade, craving, withdrawal and abstinence, we found that buprenorphine plasma concentrations sustained at 2-3 ng/ml (corresponding to ≥70% brain mu-opioid receptor occupancy) optimized treatment outcomes in the majority of participants, while some individuals (e.g., injecting opioid users) needed higher concentrations. Our work also included non-linear mixed effects modeling and survival analysis, which identified a number of demographic, genetic and social factors modulating treatment response and retention. Altogether, these findings provide key information on buprenorphine plasma levels that optimize clinical outcomes and increase the likelihood of individual treatment success. NLM identifiers: NCT02044094, NCT02357901.
Project description:AimTo assess the effectiveness and cost-effectiveness of office-based buprenorphine treatment (OBBT) in the U.S.Design setting and participantsWe performed a model-based analysis of buprenorphine treatment provided in a primary care setting for the U.S. population with OUD.InterventionBuprenorphine treatment provided in a primary care setting.MeasurementsFatal and nonfatal overdoses and deaths over five years, discounted lifetime quality-adjusted life years (QALYs), costs.FindingsFor a cohort of 100,000 untreated individuals who enter OBBT, approximately 9350 overdoses would be averted over five years; of these, approximately 900 would have been fatal. OBBT compared to no treatment would yield 1.07 incremental lifetime QALYs per person at an incremental cost of $17,000 per QALY gained when using a healthcare perspective. If OBBT is half as effective and twice as expensive as assumed in the base case, the incremental cost when using a healthcare perspective is $25,500 per QALY gained. Using a limited societal perspective that additionally includes patient costs and criminal justice costs, OBBT is cost-saving compared to no treatment even under pessimistic assumptions about efficacy and cost.ConclusionsExpansion of OBBT would be highly cost-effective compared to no treatment when considered from a healthcare perspective, and cost-saving when reduced criminal justice costs are included. Given the continuing opioid crisis in the U.S., expansion of this care option should be a high priority.
Project description:Rates of major depressive disorder (MDD) are disproportionally high in subjects with opioid use disorder (OUD) relative to the general population. MDD is often more severe in OUD patients, leading to compliance issues with maintenance therapies and poor outcomes. A growing body of literature suggests that endogenous opioid system dysregulation may play a role in the emergence of MDD. Buprenorphine, a mixed opioid receptor agonist/antagonist approved for the treatment of OUD and chronic pain, may have potential as a novel therapeutic for MDD, especially for patients with a dual diagnosis of MDD and OUD. This paper presents a comprehensive review of papers relevant to the assessment of buprenorphine as a treatment for MDD, OUD, and/or suicide compiled using electronic databases per Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The principal goal of this literature review was to compile the clinical studies that have interrogated the antidepressant activity of buprenorphine in opioid naïve MDD patients and OUD patients with comorbid MDD. Evidence supporting buprenorphine's superiority over methadone for treating comorbid OUD and MDD was also considered. Finally, recent evidence for the ability of buprenorphine to alleviate suicidal ideation in both opioid-naïve patients and opioid-experienced patients was evaluated. Synthesizing all of this information, buprenorphine emerges as a potentially effective therapeutic for the dual purposes of treating MDD and OUD.
Project description:ObjectivesExpanded access to buprenorphine induction, including via emergency departments, increases the likelihood of treatment engagement for patients with opioid use disorder (OUD). However, longer-term retention among these patients remains a challenge. In this study, we aimed to identify barriers to engaging and retaining patients with OUD in care and additional services that might improve retention.MethodsWe surveyed counselors at an urban safety net addictions treatment clinic.ResultsTwenty-five of 27 (93%) eligible counselors responded. Counselors described patients who were homeless, had no prior treatment history, or lacked health insurance as hardest to retain in treatment. Housing assistance, residential treatment placement, regular access to a phone, and mental health services were thought to be most beneficial for improving retention. Respondents most often reported that screening for services should happen at intake, and almost all respondents agreed that "retention of patients receiving treatment for OUD would improve with a dedicated case manager and/or more coordinated case management services."ConclusionsEngagement in OUD treatment would be improved with interventions to mitigate the significant social and psychiatric comorbidities of addiction. Community- and emergency department-initiated buprenorphine is a promising intervention whose full promise cannot be realized without interventions to improve treatment retention.
Project description:ObjectivesBuprenorphine and other medications for opioid use disorder (OUD) are recommended as standard of care in the treatment of OUD and are associated with positive health and addiction-related outcomes. Despite benefits, discontinuation is common, with half of patients discontinuing in the first year of treatment. Addressing OUD is a major clinical priority, yet little is known about the causes of medication discontinuation from the patient perspective.MethodsFrom March 2021 to April 2022, we conducted qualitative interviews with patients who had discontinued buprenorphine for the treatment of OUD within the past 12 months. Eligible participants were selected from 2 Veterans Health Administration Health Care Systems in Oregon. Coding and analysis were guided by conventional qualitative content analysis.ResultsTwenty participants completed an interview; 90% were White and 90% were male, and the mean age was 54.2 years. Before discontinuation, participants had received buprenorphine for 8.3 months on average (range, 1-40 months); 80% had received buprenorphine for less than 12 months. Qualitative analysis identified the following themes relating to discontinuation: health system barriers (eg, logistical hurdles, rules and policy violations), medication effects (adverse effects; attributed adverse effects, lack of efficacy in treating chronic pain) and desire for opioid use. Patient description of decisions to discontinue buprenorphine could be multicausal, reflecting provider or system-level barriers in interaction with patient complexity or medication ambivalence.ConclusionsStudy results identify several actionable ways OUD treatment could be modified to enhance patient retention.
Project description:ImportanceThe demand for medications for opioid use disorder (MOUD) in rural US counties far outweighs their availability. Novel approaches to extend treatment capacity include telemedicine (TM) and mobile treatment on demand; however, their combined use has not been reported or evaluated.ObjectiveTo evaluate the use of a TM mobile treatment unit (TM-MTU) to improve access to MOUD for individuals living in an underserved rural area.Design, setting, and participantsThis quality improvement study evaluated data collected from adult outpatients with a diagnosis of OUD enrolled in the TM-MTU initiative from February 2019 (program inception) to June 2020. Program staff traveled to rural areas in a modified recreational vehicle equipped with medical, videoconferencing, and data collection devices. Patients were virtually connected with physicians based more than 70 miles (112 km) away. Data analysis was performed from June to October 2020.InterventionPatients received buprenorphine prescriptions after initial teleconsultation and follow-up visits from a study physician specialized in addiction psychiatry and medicine.Main outcomes and measuresThe primary outcome was 3-month treatment retention, and the secondary outcome was opioid-positive urine screens. Exploratory outcomes included use of other drugs and patients' travel distance to treatment.ResultsA total of 118 patients were enrolled in treatment, of whom 94 were seen for follow-up treatment predominantly (at least 2 of 3 visits [>50%]) on the TM-MTU; only those 94 patients' data are considered in all analyses. The mean (SD) age of patients was 36.53 (9.78) years, 59 (62.77%) were men, 71 (75.53%) identified as White, and 90 (95.74%) were of non-Hispanic ethnicity. Fifty-five patients (58.51%) were retained in treatment by 3 months (90 days) after baseline. Opioid use was reduced by 32.84% at 3 months, compared with baseline, and was negatively associated with treatment duration (F = 12.69; P = .001). In addition, compared with the nearest brick-and-mortar treatment location, TM-MTU treatment was a mean of 6.52 miles (range, 0.10-58.70 miles) (10.43 km; range, 0.16-93.92 km) and a mean of 10 minutes (range, 1-49 minutes) closer for patients.Conclusions and relevanceThese data demonstrate the feasibility of combining TM with mobile treatment, with outcomes (retention and opioid use) similar to those obtained from office-based TM MOUD programs. By implementing a traveling virtual platform, this clinical paradigm not only helps fill the void of rural MOUD practitioners but also facilitates access to underserved populations who are less likely to reach traditional medical settings, with critical relevance in the context of the COVID-19 pandemic.
Project description:ObjectiveAlthough opioid maintenance is a first-line approach for treating opioid use disorder (OUD), suboptimal treatment outcomes have been reported among emerging adults (EAs; 18-25 years of age). In this secondary analysis, we compared treatment outcomes between EAs and older adults (OAs; ≥ 26 years of age) receiving low-barrier, technology-assisted Interim Buprenorphine Treatment (IBT) during waitlist delays to comprehensive opioid maintenance treatment.MethodParticipants were 35 individuals with OUD who received IBT consisting of 12-weeks of buprenorphine maintenance with bi-monthly clinic visits and technology-assisted monitoring. At monthly follow-up assessments, participants completed staff-observed urinalysis, the Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI-II), and Addiction Severity Index (ASI).ResultsAt study intake, EAs (n = 10) reported greater past-year intravenous drug use and greater employment, legal, and psychiatric severity (p's < .05) compared to OAs (n = 25). Despite these initial differences, there were no significant differences in the percentages of urine specimens testing negative for illicit opioids between EA and OA participants at Study Week 4 (90 % vs. 88 %, p = .99), Week 8 (80 % vs. 76 %, p = .99) or Week 12 (60 % vs. 68 %, p = .71). Relative to their older peers, EAs also demonstrated significantly greater improvements on the BAI, BDI-II, and ASI Employment and Legal subscales (p's < .05).ConclusionsDespite presenting with greater past-year intravenous drug use and psychosocial severity relative to OAs, EAs responded favorably to the IBT intervention.