Buprenorphine maintenance therapy in opioid-addicted health care professionals returning to clinical practice: a hidden controversy.
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ABSTRACT:
SUBMITTER: Hamza H
PROVIDER: S-EPMC3538407 | biostudies-literature | 2012 Mar
REPOSITORIES: biostudies-literature
Publications
Buprenorphine maintenance therapy in opioid-addicted health care professionals returning to clinical practice: a hidden controversy.
Hamza Heather H Bryson Ethan O EO
Mayo Clinic proceedings 20120301 3
It remains controversial whether it is safe for recovering health care professionals to return to clinical practice after treatment for drug addiction. One specific component of reentry that remains particularly contentious is the use of pharmacotherapeutics, specifically buprenorphine, as opioid substitution therapy for health care professionals who wish to return to clinical work. Because health care professionals are typically engaged in safety-sensitive work with considerable consequences wh ...[more]
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Project description:ContextThe usual treatment for opioid-addicted youth is detoxification and counseling. Extended medication-assisted therapy may be more helpful.ObjectiveTo evaluate the efficacy of continuing buprenorphine-naloxone for 12 weeks vs detoxification for opioid-addicted youth.Design, setting, and patientsClinical trial at 6 community programs from July 2003 to December 2006 including 152 patients aged 15 to 21 years who were randomized to 12 weeks of buprenorphine-naloxone or a 14-day taper (detox).InterventionsPatients in the 12-week buprenorphine-naloxone group were prescribed up to 24 mg per day for 9 weeks and then tapered to week 12; patients in the detox group were prescribed up to 14 mg per day and then tapered to day 14. All were offered weekly individual and group counseling.Main outcome measureOpioid-positive urine test result at weeks 4, 8, and 12.ResultsThe number of patients younger than 18 years was too small to analyze separately, but overall, patients in the detox group had higher proportions of opioid-positive urine test results at weeks 4 and 8 but not at week 12 (chi(2)(2) = 4.93, P = .09). At week 4, 59 detox patients had positive results (61%; 95% confidence interval [CI] = 47%-75%) vs 58 12-week buprenorphine-naloxone patients (26%; 95% CI = 14%-38%). At week 8, 53 detox patients had positive results (54%; 95% CI = 38%-70%) vs 52 12-week buprenorphine-naloxone patients (23%; 95% CI = 11%-35%). At week 12, 53 detox patients had positive results (51%; 95% CI = 35%-67%) vs 49 12-week buprenorphine-naloxone patients (43%; 95% CI = 29%-57%). By week 12, 16 of 78 detox patients (20.5%) remained in treatment vs 52 of 74 12-week buprenorphine-naloxone patients (70%; chi(2)(1) = 32.90, P < .001). During weeks 1 through 12, patients in the 12-week buprenorphine-naloxone group reported less opioid use (chi(2)(1) = 18.45, P < .001), less injecting (chi(2)(1) = 6.00, P = .01), and less nonstudy addiction treatment (chi(2)(1) = 25.82, P < .001). High levels of opioid use occurred in both groups at follow-up. Four of 83 patients who tested negative for hepatitis C at baseline were positive for hepatitis C at week 12.ConclusionsContinuing treatment with buprenorphine-naloxone improved outcome compared with short-term detoxification. Further research is necessary to assess the efficacy and safety of longer-term treatment with buprenorphine for young individuals with opioid dependence.Trial registrationclinicaltrials.gov Identifier: NCT00078130.
| S-EPMC2610690 | biostudies-literature
Project description:IMPORTANCE:Prescription opioid dependence is increasing and creates a significant public health burden, but primary care physicians lack evidence-based guidelines to decide between tapering doses followed by discontinuation of buprenorphine hydrochloride and naloxone hydrochloride therapy (hereinafter referred to as buprenorphine therapy) or ongoing maintenance therapy. OBJECTIVE:To determine the efficacy of buprenorphine taper vs ongoing maintenance therapy in primary care-based treatment for prescription opioid dependence. DESIGN, SETTING, AND PARTICIPANTS:We conducted a 14-week randomized clinical trial that enrolled 113 patients with prescription opioid dependence from February 17, 2009, through February 1, 2013, in a single primary care site. INTERVENTIONS:Patients were randomized to buprenorphine taper (taper condition) or ongoing buprenorphine maintenance therapy (maintenance condition). The buprenorphine taper was initiated after 6 weeks of stabilization, lasted for 3 weeks, and included medications for opioid withdrawal, after which patients were offered naltrexone treatment. The maintenance group received ongoing buprenorphine therapy. All patients received physician and nurse support and drug counseling. MAIN OUTCOMES AND MEASURES:Illicit opioid use via results of urinanalysis and patient report, treatment retention, and reinitiation of buprenorphine therapy (taper group only). RESULTS:During the trial, the mean percentage of urine samples negative for opioids was lower for patients in the taper group (35.2% [95% CI, 26.2%-44.2%]) compared with those in the maintenance group (53.2% [95% CI, 44.3%-62.0%]). Patients in the taper group reported more days per week of illicit opioid use than those in the maintenance group once they were no longer receiving buprenorphine (mean use, 1.27 [95% CI, 0.60-1.94] vs 0.47 [95% CI, 0.19-0.74] days). Patients in the taper group had fewer maximum consecutive weeks of opioid abstinence compared with those in the maintenance group (mean abstinence, 2.70 [95% CI, 1.72-3.75] vs 5.20 [95% CI, 4.16-6.20] weeks). Patients in the taper group were less likely to complete the trial (6 of 57 [11%] vs 37 of 56 [66%]; P?<?.001). Sixteen patients in the taper group reinitiated buprenorphine treatment after the taper owing to relapse. CONCLUSIONS AND RELEVANCE:Tapering is less efficacious than ongoing maintenance treatment in patients with prescription opioid dependence who receive buprenorphine therapy in primary care. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT00555425.
| S-EPMC6167926 | biostudies-literature
Project description:OBJECTIVE:Although buprenorphine treatment reduces risk of overdose and death in opioid use disorder, most patients discontinue treatment within a few weeks or months. Adverse health outcomes following buprenorphine discontinuation were compared among patients who were successfully retained beyond 6 months of continuous treatment, a minimum treatment duration recently endorsed by the National Quality Forum. METHODS:A retrospective longitudinal cohort analysis was performed using the MarketScan multistate Medicaid claims database (2013-2017), covering 12 million beneficiaries annually. The sample included adults (18-64 years of age) who received buprenorphine continuously for ?180 days by cohorts retained for 6-9 months, 9-12 months, 12-15 months, and 15-18 months. For outcome assessment in the postdiscontinuation period, patients had to be continuously enrolled in Medicaid for 6 months after buprenorphine discontinuation. Primary adverse outcomes included all-cause emergency department visits, all-cause inpatient hospitalizations, opioid prescriptions, and drug overdose (opioid or non-opioid). RESULTS:Adverse events were common across all cohorts, and almost half of patients (42.1%-49.9%) were seen in the emergency department at least once. Compared with patients retained on buprenorphine for 6-9 months (N=4,126), those retained for 15-18 months (N=931) had significantly lower odds of emergency department visits (odds ratio=0.75, 95% CI=0.65-0.86), inpatient hospitalizations (odds ratio=0.79, 95% CI=0.64-0.99), and filling opioid prescriptions (odds ratio=0.67, 95% CI=0.56-0.80) in the 6 months following discontinuation. Approximately 5% of patients across all cohorts experienced one or more medically treated overdoses. CONCLUSIONS:Risk of acute care service use and overdose were high following buprenorphine discontinuation irrespective of treatment duration. Superior outcomes became significant with treatment duration beyond 15 months, although rates of the primary adverse outcomes remained high.
| S-EPMC7002204 | biostudies-literature
Project description:A sublingual soluble-film formulation of buprenorphine/naloxone (B/N) has been approved by the US Food and Drug Administration for the treatment of opioid dependency. This preparation provides unit-dose, child-resistant packaging amenable to tracking and accountability, offers more rapid dissolution, and has a potentially preferred taste vs. tablets. This study compared the ability of buprenorphine (B) and B/N films to suppress spontaneous withdrawal in opioid-dependent volunteers. Participants were maintained on morphine and underwent challenge sessions to confirm sensitivity to naloxone-induced opioid withdrawal. Subjects were randomized to receive either B (16 mg, n = 18) or B/N (16/4 mg, n = 16) soluble films for 5 days. The primary outcome measure was the Clinical Opiate Withdrawal Scale (COWS) score. Thirty-four subjects completed induction onto soluble films. There was a significant decrease in COWS scores but no significant differences between the groups. The results support the use of B and B/N soluble films as safe and effective delivery methods for opioid induction.
| S-EPMC3225026 | biostudies-literature
Project description:To compare the effects of a short or long taper schedule after buprenorphine stabilization on participant outcomes as measured by opioid-free urine tests at the end of each taper period.This multi-site study sponsored by Clinical Trials Network (CTN, a branch of the US National Institute on Drug Abuse) was conducted from 2003 to 2005 to compare two taper conditions (7 days and 28 days). Data were collected at weekly clinic visits to the end of the taper periods, and at 1-month and 3-month post-taper follow-up visits.Eleven out-patient treatment programs in 10 US cities.Non-blinded dosing with Suboxone during the 1-month stabilization phase included 3 weeks of flexible dosing as determined appropriate by the study physicians. A fixed dose was required for the final week before beginning the taper phase.The percentage of participants in each taper group providing urine samples free of illicit opioids at the end of the taper and at follow-up.At the end of the taper, 44% of the 7-day taper group (n = 255) provided opioid-free urine specimens compared to 30% of the 28-day taper group (n = 261; P = 0.0007). There were no differences at the 1-month and 3-month follow-ups (7-day = 18% and 12%; 28-day = 18% and 13%, 1 month and 3 months, respectively).For individuals terminating buprenorphine pharmacotherapy for opioid dependence, there appears to be no advantage in prolonging the duration of taper.
| S-EPMC3150159 | biostudies-literature
Project description:ImportanceExpanding Medicaid eligibility could affect prescriptions of buprenorphine with naloxone, an established treatment for opioid use disorder, and opioid pain relievers (OPRs).ObjectiveTo examine changes in prescriptions of buprenorphine with naloxone and OPRs after the US Affordable Care Act Medicaid expansion.Design, setting, and participantsIn this cohort study, longitudinal, patient-level, retail pharmacy claims were extracted from IQVIA real-world data from an anonymized, longitudinal, prescription database. The sample included 11.9 million individuals who filled 2 or more prescriptions for a prescription opioid during at least 1 year between January 1, 2010, and December 31, 2015, from California, Maryland, and Washington (expansion states) and Florida and Georgia (nonexpansion states). Data analysis was conducted from August 1, 2017, to May 31, 2018. Data were aggregated to county-year observations (N = 2082) and linked to county-level covariates. For each outcome, a difference-in-differences regression model was estimated comparing changes before and after expansion in expansion vs nonexpansion counties. Models were adjusted for county demographics, uninsured rate, and overdose mortality in the baseline year (2010).ExposuresPresence of Medicaid expansion in the year.Main outcomes and measuresFor buprenorphine with naloxone and OPRs, rates per 100 000 county residents were calculated separately for any prescriptions overall and by different payment sources. Mean days of medication per county among people filling prescriptions for these agents were also determined.ResultsThe study sample included 11.9 million individuals (expansion states: 40.9% men; mean [SD] age, 44.1 [13.8] years; nonexpansion states: 41.0% men; mean [SD] age, 43.7 [13.7] years). In expansion counties, 68.8 individuals per 100 000 county residents filled buprenorphine with naloxone and 5298.3 filled OPR prescriptions in 2010. After expansion, buprenorphine with naloxone fills per 100 000 county residents increased significantly in expansion relative to nonexpansion counties (8.7; 95% CI, 1.7 to 15.7). Opioid pain reliever fills per 100 000 county residents did not significantly change in expansion counties relative to nonexpansion counties (327.4; 95% CI -202.5 to 857.4). The rate of OPRs per 100 000 county residents paid for by Medicaid significantly increased (374.0; 95% CI, 258.3 to 489.7). There were no significant changes in days per 100 000 county residents of either medication after expansion.Conclusions and relevanceMedicaid expansion significantly increased buprenorphine with naloxone prescriptions per 100 000 county residents in expansion counties, suggesting that expansion improved access to opioid use disorder treatment. Expansion did not significantly increase the overall rate per 100 000 county residents of OPR prescriptions, but increased the population with OPRs paid for by Medicaid. This finding therefore suggests the growing importance of Medicaid in pain management and addiction prevention.
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Project description:Gender differences are known to occur in the pharmacokinetics of many drugs. Mechanisms may include differences in body composition, body weight, cardiac output, hormonal status, and use of different co-medications. Recently subtle gender-dependent differences in cytochrome P450 (CYP) 3A-dependent metabolism have been demonstrated. Buprenorphine N-dealkylation to norbuprenorphine is primarily performed by CYP3A. We therefore asked whether gender-dependent differences occur in the pharmacokinetics of buprenorphine.A retrospective examination was made of control (buprenorphine/naloxone-only) sessions from a number of drug interaction studies between buprenorphine and antiretroviral drugs. Twenty males and eleven females were identified who had a negative cocaine urine test prior to participation in the control session and were all on the same maintenance dose (16/4 mg) of sublingual buprenorphine/naloxone. Pharmacokinetic data from their control sessions (buprenorphine/naloxone only) were sorted by gender and compared using the two-sample t-test.Females had significantly higher area under the plasma concentration curve (AUC) and maximum plasma concentrations for buprenorphine, norbuprenorphine and norbuprenorphine-3-glucuronide. AUCs relative to dose per body weight and surface area were significantly higher for only norbuprenorphine. AUCs relative to lean body mass were, however, not significantly different.Gender-related differences exist in the pharmacokinetics of buprenorphine; differences in body composition appear to have a major impact; differences in CYPA-dependent metabolism may also contribute.
| S-EPMC3162987 | biostudies-literature
Project description:To evaluate the safety and efficacy of buprenorphine implants (BI) versus placebo implants (PI) for the treatment of opioid dependence. A secondary aim compared BI to open-label sublingual buprenorphine/naloxone tablets (BNX).Randomized, double-blind, placebo-controlled trial. Subjects received either four buprenorphine implants (80 mg/implant) (n = 114), four placebo implants (n = 54) or open-label BNX (12-16 mg/day) (n = 119).Twenty addiction treatment centers.Adult out-patients (ages 18-65) with DSM-IV-TR opioid dependence.The primary efficacy end-point was the percentage of urine samples negative for opioids collected from weeks 1 to 24, examined as a cumulative distribution function (CDF).The BI CDF was significantly different from placebo (P < 0.0001). Mean [95% confidence interval (CI)] proportions of urines negative for opioids were: BI = 31.2% (25.3, 37.1) and PI = 13.4% (8.3, 18.6). BI subjects had a higher study completion rate relative to placebo (64 versus 26%, P < 0.0001), lower clinician-rated (P < 0.0001) and patient-rated (P < 0.0001) withdrawal, lower patient-ratings of craving (P < 0.0001) and better subjects' (P = 0.031) and clinicians' (P = 0.022) global ratings of improvement. BI also resulted in significantly lower cocaine use (P = 0.0016). Minor implant-site reactions were comparable in the buprenorphine [27.2% (31 of 114)] and placebo groups [25.9% (14 of 54)]. BI were non-inferior to BNX on percentage of urines negative for opioids [mean (95% CI) = 33.5 (27.3, 39.6); 95% CI for the difference of proportions = (-10.7, 6.2)].Compared with placebo, buprenorphine implants result in significantly less frequent opioid use and are non-inferior to sublingual buprenorphine/naloxone tablets.
| S-EPMC4669043 | biostudies-literature
Project description:Incentive-based pay-for-performance (P4P) models have been introduced during the last 2 decades as a mechanism to improve the delivery of evidence-based care that ensures clinical quality and improves health outcomes. There is mixed evidence that P4P has a positive effect on health outcomes and researchers cite lack of engagement from health care professionals as a limiting factor. This qualitative metasynthesis of existing qualitative research was conducted to integrate health care professionals' perceptions of P4P in clinical practice. Four themes emerged during the research process: positive perceptions of the value of performance measurement and associated financial incentives; negative perceptions of the performance measurement and associated financial incentives; perceptions of how P4P programs influence the quality/appropriateness of care; and perceptions of the influence of P4P program on professional roles and workplace dynamics. Identifying factors that influence health care professionals' perceptions about this type of value-based payment model will guide future research.
| S-EPMC7249558 | biostudies-literature
Project description:Opioid use disorders (OUDs) have long been a global problem, but the prevalence rates have increased over 20 years to epidemic proportions in the US, with concomitant increases in morbidity and all-cause mortality, but especially opioid overdose. These increases are in part attributable to a several-fold expansion in the prescription of opioid pain medications over the same time period. Opioid detoxification and psychosocial treatments alone have each not yielded sufficient efficacy for OUD, but μ-opioid receptor agonist, partial agonist, and antagonist medications have demonstrated the greatest overall benefit in OUD treatment. Buprenorphine, a μ-opioid receptor partial agonist, has been used successfully on an international basis for several decades in sublingual tablet and film preparations for the treatment of OUD, but the nature of formulation, which is typically self-administered, renders it susceptible to nonadherence, diversion, and accidental exposure. This article reviews the clinical trial data for novel buprenorphine delivery systems in the form of subcutaneous depot injections, transdermal patches, and subdermal implants for the treatment of OUD and discusses both the clinical efficacy of longer-acting formulations through increasing consistent medication exposure and their potential utility in reducing diversion. These new delivery systems also offer new dosing opportunities for buprenorphine and strategies for dosing intervals in the treatment of OUD.
| S-EPMC5584886 | biostudies-literature