Initiating buprenorphine to treat opioid use disorder without prerequisite withdrawal: a systematic review.
Ontology highlight
ABSTRACT: Background
Opioid withdrawal symptoms prior to buprenorphine initiation may be intolerable and as a result, alternative strategies have emerged. We aim to systematically review the efficacy and safety of buprenorphine initiation that aims to omit prerequisite withdrawal.Methods
We conducted a systematic literature search of MEDLINE and CENTRAL from 1996 through April 10, 2020, augmented with searches in Google Scholar and www.clinicaltrials.gov . A study was included if it was in patients with substance use disorder or chronic pain that were taking a full mu opioid agonist and transitioning to buprenorphine without preceding withdrawal, and reported withdrawal during initiation as an outcome. Two investigators independently screened citations and articles for inclusion, collected data using a standardized data collection tool, and assessed study risk of bias.Results
We included 15 case reports/series, reporting 24 unique cases, in our qualitative synthesis. No controlled studies were identified. Microdosing and bridging with a buprenorphine patch were the most common strategies reported. Transition to buprenorphine with complete cessation of opioid agonists was achieved in 87.5% (n = 21) of cases. Withdrawal during initiation occurred in 58.3% (n = 14) of cases, two of which were at least moderate in severity.Conclusion
Buprenorphine initiation strategies that omit prerequisite withdrawal have emerged. Low quality evidence from case reports suggests withdrawal during initiation is common but most often mild in severity. There is an unmet need for controlled studies to inform their efficacy and safety compared with traditional strategies, including outcomes during initiation and in the long-term.
SUBMITTER: Adams KK
PROVIDER: S-EPMC8186092 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:Few studies examine the effectiveness of treatments for opioid use disorder (OUD) among Black individuals despite recent evidence suggesting opioid overdose death rates are, in some cases, highest and increasing at a faster rate among Black people compared to other racial/ethnic groups. This secondary analysis study investigated treatment preference, retention, and relapse rates amongst a subgroup of 73 Black participants with OUD (81% male, mean age 39.05, SD = 11.80) participating in a 24-week multisite randomized clinical trial ("X:BOT") comparing the effectiveness of extended-release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX) between 2014 and 2017. Chi-square analyses were used to investigate treatment preference assessed at baseline, and logistic regression analyses were used to investigate differences in the odds of retention and relapse assessed over the 24-week course of treatment between treatment groups. Our findings suggest no differences in preference for XR-NTX versus BUP-NX. However, similar to the parent trial, there was an induction hurdle such that only 59.5% of those randomized to XR-NTX successfully initiated medication compared to 91.6% of those randomized to BUP-NX (OR = 0.13, 95% CI = 0.04, 0.52). No significant differences were found in treatment retention (intention-to-treat: OR = 1.19, 95% CI = 0.43, 3.28; per-protocol [i.e., those who initiated medication]: OR = 0.60, 95% CI = 0.20, 1.82) or relapse rates between treatment groups (intention-to-treat: OR = 1.53, 95% CI = 0.57, 4.13; per-protocol: OR = 0.69, 95% CI = 0.23, 2.06). Although there is a significant initiation hurdle with XR-NTX, once inducted, both medications appear similar in effectiveness, but as in the main study, dropout rates were high. Future research is needed on how to improve adherence.
| S-EPMC7433932 | biostudies-literature
Project description:BackgroundBuprenorphine is a highly effective medication for opioid use disorder that is underused by health care professionals (HCPs). Medications for opioid use disorder (MOUD) misinformation may be an important barrier to buprenorphine access, but most implementation strategies have aimed to reduce negative attitudes towards patients with opioid use disorder (OUD) rather than misinformation specific to buprenorphine use. In this study, we assessed the degree to which HCPs endorsed misinformation related to buprenorphine, and whether this is associated with willingness to provide care to patients with OUD.MethodsIn September-December of 2022, we surveyed HCPs practicing in Ohio (n = 409). Our primary outcomes included a previously validated 5-item measure of HCP willingness to treat patients with OUD, and three other measures of willingness. Our key independent variable was a study-developed 5-item measure of endorsement of misinformation related to buprenorphine, which assessed beliefs in buprenorphine's efficacy in managing withdrawal symptoms and reducing overdose deaths as well as beliefs about the role of buprenorphine in achieving remission. We computed descriptive and bivariable statistics and fit regression models predicting each outcome of interest.ResultsOn average, HCPs scored 2.34 out of 5.00 (SD = 0.80) on the composite measure of buprenorphine misinformation. 48.41% of participants endorsed at least one piece of misinformation. The most endorsed items were that buprenorphine is ineffective at reducing overdose deaths (M = 2.75, SD =0 .98), and that its use substitutes one drug for another (M = 2.41, SD = 1.25). HCP endorsement of buprenorphine misinformation significantly and negatively predicted willingness to work with patients with OUD (b = - 0.34; 95% CI - 0.46, - 0.21); intentions to increase time spent with this patient population (b = - 0.36; 95% CI - 5.86, - 1.28); receipt of an X-waiver (OR = 0.54, 95% CI 0.38, 0.77); and intention to get an X-waiver (OR: 0.56; 95% CI: 0.33-0.94).ConclusionsMisinformation is common among HCPs and associated with lower willingness to treat patients with OUD. Implementation strategies to increase MOUD use among HCPs should specifically counter misinformation related to buprenorphine.Clinical trial registrationClinicaltrials.gov, NCT05505227. Registered 17 August 2022, https://clinicaltrials.gov/ct2/show/NCT05505227.
| S-EPMC10797921 | biostudies-literature
Project description:IntroductionVeterans with opioid use disorder have an increased risk of suicide and overdose compared with the general population. Buprenorphine, a U.S. Food and Drug Administration-approved medication to treat opioid use disorder, has shown benefits, including decreased risk of illicit drug use and overdose. This study assesses the mortality outcomes with buprenorphine pharmacotherapy among Veterans up to 5 years from treatment initiation.MethodsThis was a retrospective cohort study of Veterans receiving buprenorphine (2008-2017) across any Veterans Health Administration facility. Buprenorphine pharmacotherapy was evaluated as a time-varying covariate. The primary outcome was death up to 5 years from treatment initiation by suicide and overdose combined; secondary outcomes included suicide, overdose, opioid-specific overdose, and all-cause death. Secondary analyses included evaluating the risk of mortality in recent discontinuation and effect modification by select characteristics. All analyses were conducted in 2020.ResultsVeterans who were not receiving buprenorphine were 4.33 (adjusted hazard ratio; 95% CI=3.60, 5.21) times more likely to die by suicide/overdose than those receiving buprenorphine pharmacotherapy on any given day, with similar protective associations with treatment across secondary outcomes. The risk of suicide/overdose was highest 8-14 days from treatment discontinuation (adjusted hazard ratio=6.54, 95% CI=4.32, 9.91) than in currently receiving buprenorphine pharmacotherapy. There was no evidence of effect modification by the selected covariates.ConclusionsMortality risk was greater among Veterans who were not receiving buprenorphine pharmacotherapy than among those who were. Providers should consider whether buprenorphine pharmacotherapy, either intermittent or continuous, may provide health benefits for their patients and prevent mortality.
| S-EPMC8384722 | biostudies-literature
Project description:BackgroundHospitalizations related to the consequences of opioid use are rising. National guidelines directing in-hospital opioid use disorder (OUD) management do not exist. OUD treatment guidelines intended for other treatment settings could inform in-hospital OUD management.ObjectiveEvaluate the quality and content of existing guidelines for OUD treatment and management.Data sourcesOVID MEDLINE, PubMed, Ovid PsychINFO, EBSCOhost CINHAL, ERCI Guidelines Trust, websites of relevant societies and advocacy organizations, and selected international search engines.Study selectionGuidelines published between January 2010 to June 2020 addressing OUD treatment, opioid withdrawal management, opioid overdose prevention, and care transitions among adults.Data extractionWe assessed quality using the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument.Data synthesisNineteen guidelines met the selection criteria. Most recommendations were based on observational studies or expert consensus. Guidelines recommended the use of nonstigmatizing language among patients with OUD; to assess patients with unhealthy opioid use for OUD using the Diagnostic Statistical Manual of Diseases-5th Edition criteria; use of methadone or buprenorphine to treat OUD and opioid withdrawal; use of multimodal, nonopioid therapy, and when needed, short-acting opioid analgesics in addition to buprenorphine or methadone, for acute pain management; ensuring linkage to ongoing methadone or buprenorphine treatment; referring patients to psychosocial treatment; and ensuring access to naloxone for opioid overdose reversal.ConclusionsIncluded guidelines were informed by studies with various levels of rigor and quality. Future research should systematically study buprenorphine and methadone initiation and titration among people using fentanyl and people with pain, especially during hospitalization.
| S-EPMC9474657 | biostudies-literature
Project description:ObjectivesOpioid use disorder remains undertreated in the United States. One of the primary mechanisms for expanding access to treatment has been the use of buprenorphine. In this study, we compare prescribing trends of buprenorphine paid through Medicaid versus other payer sources.MethodsCombined data from California's prescription drug monitoring program and California's Department of Health Care Services was used to obtain statewide quarterly prescription rates for buprenorphine, indicated for the treatment of opioid use disorder, from 2012 to 2018.ResultsFrom 2012 to 2018, the rate of individuals treated with buprenorphine in Medicaid increased by 657% (1.39-10.5 Medicaid beneficiaries per 10,000) with increases beginning in 2014 and continuing through 2018. Rate of individual prescribing among non-Medicaid sources increased by 93.7% (6.54-12.7 non-Medicaid individuals per 10,000) with most increases occurring before 2014.ConclusionsCalifornia Medicaid has made considerable gains in buprenorphine access, with access growing steadily even after expansions through the Affordable Care Act plateaued. In contrast, recent gains in buprenorphine access for individuals without Medicaid are uninspiring, indicating that initiatives to improve buprenorphine access to patients without Medicaid are urgently needed.
| S-EPMC9267415 | biostudies-literature
Project description:AimsTo assess the safety of buprenorphine compared with methadone to treat pregnant women with opioid use disorder.MethodsWe searched PubMed, Embase and the Cochrane Library from inception to February 2015 for randomized controlled trials (RCT) and observational cohort studies (OBS) that compared buprenorphine with methadone for treating opioid-dependent pregnant women. Two reviewers assessed independently the titles and abstracts of all search results and full texts of potentially eligible studies reporting original data for maternal/fetal/infant death, preterm birth, fetal growth outcomes, fetal/congenital anomalies, fetal/child neurodevelopment and/or maternal adverse events. We ascertained each study's risk of bias using validated instruments and assessed the strength of evidence for each outcome using established methods. We computed effect sizes using random-effects models for each outcome with two or more studies.ResultsThree RCTs (n = 223) and 15 cohort OBSs (n = 1923) met inclusion criteria. In meta-analyses using unadjusted data and methadone as comparator, buprenorphine was associated with lower risk of preterm birth [RCT risk ratio (RR)?=?0.40, 95% confidence interval (CI)?=?0.18, 0.91; OBS RR?=?0.67, 95% CI?=?0.50, 0.90], greater birth weight [RCT weighted mean difference (WMD)?=?277?g, 95% CI?=?104, 450; OBS WMD?=?265?g, 95% CI?=?196, 335] and larger head circumference [RCT WMD?=?0.90?cm, 95% CI?=?0.14, 1.66; OBS WMD?=?0.68?cm, 95% CI?=?0.41, 0.94]. No treatment differences were observed for spontaneous fetal death, fetal/congenital anomalies and other fetal growth measures, although the power to detect such differences may be inadequate due to small sample sizes.ConclusionsModerately strong evidence indicates lower risk of preterm birth, greater birth weight and larger head circumference with buprenorphine treatment of maternal opioid use disorder during pregnancy compared with methadone treatment, and no greater harms.
| S-EPMC5129590 | biostudies-literature
Project description:AimThe aim of this study was to characterize quality of buprenorphine care for opioid use disorder (OUD) by quantifying buprenorphine initiation, engagement, and maintenance for individuals in a large, diverse, real-world cohort in the United States.DesignThis was a retrospective cohort analysis.SettingOUD treatment in the outpatient setting.ParticipantsA total of 45,210 commercially insured and Medicare Advantage (MA) enrollees 18 years or older in the OptumLabs Data Warehouse with an index diagnosis of OUD between January 1, 2018 and December 31, 2018.InterventionsTreatment with buprenorphine.MeasurementsWe calculated 6 measures of buprenorphine treatment quality. We conducted survival analyses to characterize treatment duration and logistic regressions to evaluate the association between clinical and sociodemographic characteristics and quality.FindingsOf 45,210 eligible individuals with OUD, ∼1 in 10 (n=4600, 10.2%) initiated buprenorphine within 365 days following diagnosis (Measure #1) and 2850 individuals (6.3%) initiated buprenorphine within 14 days of diagnosis (Measure #2). Of individuals initiating treatment within 14 days of diagnosis, 1769 (62.1%) had 2 or more buprenorphine claims within 34 days of initiation (Measure #3). Of the 4600 individuals who received buprenorphine, 2300 (50.0%) were maintained in care with 180 days or more of covered buprenorphine treatment during 365 days after diagnosis (Measure #4). Finally, of the 4600 individuals who received buprenorphine, 2543 (55.3%) did not fill any other concurrent opioid analgesic (Measure #5) and 2951 (64.2%) did not fill any concurrent benzodiazepine (Measure #6). Quality was generally lower for individuals with MA compared with commercial coverage and among Hispanic and Black adults compared with White adults.ConclusionWidespread gaps exist in quality of buprenorphine treatment initiation, engagement, and maintenance among commercially insured and MA enrollees with OUD.
| S-EPMC8026663 | biostudies-literature
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.
| S-EPMC9549700 | biostudies-literature
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.
| S-EPMC9518754 | biostudies-literature
Project description:BackgroundTwo phase I studies assessed the pharmacokinetics of buprenorphine, its metabolite norbuprenorphine, and naloxone following administration of buprenorphine/naloxone sublingual tablets in Chinese participants.MethodsIn the first phase I, open-label, single ascending-dose (SAD) study, 82 opioid-naïve volunteers received a single buprenorphine/naloxone dose ranging from 2 mg/0.5 mg to 24 mg/6 mg while under naltrexone block. In a second phase I, open-label, multiple ascending-dose (MAD) study, 27 patients with opioid dependence in withdrawal received buprenorphine/naloxone doses of either 16 mg/4 mg or 24 mg/6 mg for 9 consecutive days. Serial blood samples were collected after a single dose (SAD study) and at steady-state (MAD study). Pharmacokinetic parameters were calculated using non-compartmental analysis. Safety assessments included adverse events monitoring and laboratory tests.ResultsThe pharmacokinetic profiles of buprenorphine and naloxone were consistent between single- and multiple-dose studies. Peak plasma concentrations (Cmax) were reached early for buprenorphine (0.75-1.0 h) and naloxone (0.5 h), supporting rapid absorption. In the SAD study, increases in plasma exposures to buprenorphine and naloxone were less than dose proportional, in line with previous observations in Western populations. Buprenorphine-to-naloxone ratios for Cmax and area under the curve (AUC) were constant over the dose range investigated and also consistent with Western populations data. Steady state was reached within 7 days of daily dosing, with slight accumulation over repeated doses. No serious adverse events were observed.ConclusionsThe present data suggest that buprenorphine/naloxone pharmacokinetic profiles in Chinese participants are consistent, overall, with those in Western populations, supporting no differences in dosing.Clinical trial registrationThe protocols were registered on the official website of the China Food and Drug Administration (CFDA): http://www.chinadrugtrials.org.cn/ ; Registration numbers CTR20132963 (RB-CN-10-0012), CTR20140153 (RB-CN-10-0015).
| S-EPMC6738359 | biostudies-literature