Buprenorphine tapering schedule and illicit opioid use.
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ABSTRACT: Aims
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.Design
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.Setting
Eleven out-patient treatment programs in 10 US cities.Intervention
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.Measurements
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.Findings
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).Conclusion
For individuals terminating buprenorphine pharmacotherapy for opioid dependence, there appears to be no advantage in prolonging the duration of taper.
SUBMITTER: Ling W
PROVIDER: S-EPMC3150159 | biostudies-literature | 2009 Feb
REPOSITORIES: biostudies-literature
Publications
Buprenorphine tapering schedule and illicit opioid use.
Ling Walter W Hillhouse Maureen M Domier Catherine C Doraimani Geetha G Hunter Jeremy J Thomas Christie C Jenkins Jessica J Hasson Albert A Annon Jeffrey J Saxon Andrew A Selzer Jeffrey J Boverman Joshua J Bilangi Richard R
Addiction (Abingdon, England) 20090201 2
<h4>Aims</h4>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.<h4>Design</h4>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 a ...[more]
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Project description:IntroductionAlthough methamphetamine use is rising in the United States, its impacts on patient outcomes among persons undergoing treatment for opioid use disorder (OUD) remain unclear. This study aims to assess the association between baseline methamphetamine/amphetamine (MA/A) use and subsequent illicit opioid use among patients with OUD initiating buprenorphine in an office-based setting.MethodsWe conducted a secondary analysis of a pilot randomized controlled trial of a behavioral mobile health intervention for buprenorphine adherence conducted over a 12-week study period at two clinic sites. The study defined baseline MA/A use by a positive urine drug test (UDT) and/or self-report of use within the past 30-days. Separate Poisson regression models with robust standard errors evaluated associations between MA/A and: i) illicit opioid use measured by weekly UDT (primary) and ii) self-reported past 30-day use at end of study (secondary). Other secondary outcomes included buprenorphine positive UDTs throughout the study and retention in OUD treatment at both weeks 12 and 24 post-randomization.ResultsAt baseline, 28 (36%) of the 78 participants had MA/A use and use was associated with a statistically significant increase in risk of testing positive for illicit opioids on UDT during the study follow-up period (adjusted relative risk (aRR)=1.54; 95% CI=1.09-2.17; p=0.015), as well as an increased risk for reported past 30-day illicit opioid use at week 12 (aRR=3.86; 95% CI=1.47-10.18; P=0.006). The study found no significant associations between MA/A use and buprenorphine positive UDT or retention in OUD treatment.ConclusionsIn this sample of patients initiating buprenorphine, methamphetamine/amphetamine use at baseline was associated with illicit opioid use over a 12-week period. These findings demonstrate how co-use of methamphetamine can impede attainment of ideal OUD treatment outcomes.
| S-EPMC10554569 | biostudies-literature
Project description:The impact of agonist dose and of physician, staff and patient engagement on treatment have not been evaluated together in an analysis of treatment for opioid use disorder. Our hypotheses were that greater agonist dose and therapeutic engagement would be associated with reduced illicit opiate use in a time-dependent manner. Publicly-available treatment data from six buprenorphine efficacy and safety trials from the Federally-supported Clinical Trials Network were used to derive treatment variables. Three novel predictors were constructed to capture the time weighted effects of buprenorphine dosage (mg buprenorphine per day), dosing protocol (whether physician could adjust dose), and clinic visits (whether patient attended clinic). We used time-in-trial as a predictor to account for the therapeutic benefits of treatment persistence. The outcome was illicit opiate use defined by self-report or urinalysis. Trial participants (N = 3022 patients with opioid dependence, mean age 36 years, 33% female, 14% Black, 16% Hispanic) were analyzed using a generalized linear mixed model. Treatment variables dose, Odds Ratio (OR) = 0.63 (95% Confidence Interval (95%CI) 0.59−0.67), dosing protocol, OR = 0.70 (95%CI 0.65−0.76), time-in-trial, OR = 0.75 (95%CI 0.71−0.80) and clinic visits, OR = 0.81 (95%CI 0.76−0.87) were significant (p-values < 0.001) protective factors. Treatment implications support higher doses of buprenorphine and greater engagement of patients with providers and clinic staff.
| S-EPMC8998781 | biostudies-literature
Project description:AimsDetermine the extent to which buprenorphine injectors continue treatment with buprenorphine-naloxone or methadone, and the impact of these treatments on substance use and HIV risk in the Republic of Georgia.MethodsRandomized controlled 12-week trial of daily-observed methadone or buprenorphine-naloxone followed by a dose taper, referral to ongoing treatment, and follow-up at week 20 at the Uranti Clinic in Tbilisi, Republic of Georgia. Eighty consenting treatment-seeking individuals (40/group) aged 25 and above who met ICD-10 criteria for opioid dependence with physiologic features and reported injecting buprenorphine 10 or more times in the past 30 days. Opioid use according to urine tests and self-reports, treatment retention, and HIV risk behavior as determined by the Risk Assessment Battery.ResultsMean age of participants was 33.7 (SD5.7), 4 were female, mean history of opioid injection use was 5.8 years (SD4.6), none were HIV+ at intake or at the 12-week assessment and 73.4% were HCV+. Sixty-eight participants (85%) completed the 12-week medication phase (33 from methadone and 35 from buprenorphine/naloxone group); 37 (46%) were in treatment at the 20-week follow-up (21 from methadone and 16 from the buprenorphine/naloxone group). In both study arms, treatment resulted in a marked reduction in unprescribed buprenorphine, other opioid use, and HIV injecting risk behavior with no clinically significant differences between the two treatment arms.ConclusionsDaily observed methadone or buprenorphine-naloxone are effective treatments for non-medical buprenorphine and other opioid use in the Republic of Georgia and likely to be useful for preventing HIV infection.
| S-EPMC3818507 | biostudies-literature
Project description:ImportanceExpanding treatment for opioid addiction has been recognized as an essential component of a comprehensive national response to the opioid epidemic. The Drug Addiction Treatment Act and its amendments attempted to improve access to treatment by involving office-based physicians in the provision of buprenorphine treatment.ObjectivesTo estimate the association of availability of buprenorphine-waivered physicians with buprenorphine treatment use and, secondarily, with prescription opioid use among Medicaid enrollees.Design, setting, and participantsThis economic evaluation study used state-level panel data analysis to estimate the association between the number of buprenorphine-waivered physicians and the Medicaid-covered buprenorphine prescribing rate and opioid prescribing rate among Medicaid fee-for-service and managed care enrollees throughout the United States between January 1, 2011, and December 31, 2016.Main outcomes and measuresBuprenorphine prescribing rate and opioid prescribing rate, measured as the number of buprenorphine prescriptions and opioid prescriptions covered by Medicaid on a quarterly basis per 1000 enrollees.ResultsThe sample included 1059 quarterly observations. Two additional 100-patient-waivered physicians per 1 000 000 residents (approximately a 10% increase) were associated with an increase in the quarterly number of Medicaid-covered buprenorphine prescriptions of 0.46 (95% CI, 0.24-0.67) per 1000 enrollees and a reduction in the quarterly number of opioid prescriptions of 1.01 (95% CI, -1.87 to -0.15) per 1000 enrollees. Furthermore, 5 additional 30-patient-waivered physicians per 1 000 000 residents (approximately a 10% increase) were associated with an increase in the quarterly number of Medicaid-covered buprenorphine prescriptions of 0.37 (95% CI, 0.22-0.52) per 1000 enrollees and a reduction in the quarterly number of opioid prescriptions of 0.96 (95% CI, -1.85 to -0.07) per 1000 enrollees. A 10% increase in the number of buprenorphine-waivered physicians was associated with an approximately 10% increase in the Medicaid-covered buprenorphine prescribing rate and a 1.2% reduction in the opioid prescribing rate.Conclusions and relevanceExpanding capacity for buprenorphine treatment holds the potential to improve access to opioid addiction treatment, which may further reduce prescription opioid use and slow the ongoing opioid epidemic in the United States.
| S-EPMC6324514 | biostudies-literature
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.
| S-EPMC10483381 | biostudies-literature
Project description:ObjectivesEffective strategies are needed to manage individuals with chronic non-cancer pain and coexistent opioid addiction. This study compared opioid discontinuation and opioid replacement protocols.MethodsWe planned to enroll 60 individuals into an open-label trial who had been treated with opioids for chronic non-cancer pain, and who also had opioid addiction. Participants were randomly assigned to one of two 6-month treatment protocols of buprenorphine/naloxone sublingual tablets: 1) tapering doses for opioid weaning or "detoxification" (active comparator group) or 2) steady doses for opioid replacement (experimental group). They were followed monthly for the study outcomes: completion of the 6-month treatment protocol and self-reported pain control, physical functioning, alcohol consumption and illicit drug use.ResultsEnrollment was terminated after enrolling 12 participants because none of the 6 assigned to receive tapering doses could successfully complete the protocol (5 were given steady doses and 1 was admitted to an inpatient chemical dependency treatment program); whereas, of the 6 assigned to receive steady doses, 5 completed the protocol (1 withdrew). This difference between the 2 treatment conditions was significant (P = 0.015). Of the 10 participants who completed the 6 month follow-up, 8 reported improved pain control and physical functioning and 5 used alcohol and/or illicit drugs.ConclusionsWe conclude that over 6 months, these participants with chronic pain and co-existent opioid addiction were more likely to adhere to an opioid replacement protocol than an opioid weaning protocol and that opioid replacement therapy with steady doses of buprenorphine/naloxone is associated with improved pain control and physical functioning.
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Project description:ImportanceAlthough substantial evidence supports buprenorphine for treatment of opioid use disorder (OUD) in controlled trials, prospective study of patient outcomes in clinical implementation of emergency department (ED) buprenorphine treatment is lacking.ObjectiveTo examine the association between buprenorphine treatment in the ED and follow-up engagement in OUD treatment 1 month later.Design, setting, and participantsThis multisite cohort study was conducted in 7 California EDs participating in a statewide implementation project to improve access to buprenorphine treatment. The study population included ED patients aged at least 18 years identified with OUD between April 1, 2021, and June 30, 2022. Data analysis was performed in October 2023.ExposureAll participants were offered buprenorphine treatment for OUD (either in ED administration, prescription, or both), the uptake of which was examined as the exposure of interest.Main outcomes and measuresThe primary outcome was engagement in OUD treatment 30 days after the ED visit, determined by patient report or clinical documentation. The association of ED buprenorphine treatment with subsequent OUD treatment engagement was estimated using hierarchical generalized linear models.ResultsThis analysis included 464 ED patients with OUD. Their median age was 36.0 (IQR, 29.0-38.7) years, and most were men (343 [73.9%]). With regard to race and ethnicity, 64 patients (13.8%) self-identified as non-Hispanic Black, 183 (39.4%) as Hispanic, and 185 as non-Hispanic White (39.9%). Most patients (396 [85.3%]) had Medicaid insurance, and more than half (262 [57.8%]) had unstable housing. Self-reported fentanyl use (242 [52.2%]) and a comorbid mental health condition (328 [71.5%]) were common. Interest in buprenorphine treatment was high: 398 patients (85.8%) received buprenorphine treatment; 269 (58.0%) were administered buprenorphine in the ED and 339 (73.1%) were prescribed buprenorphine. With regard to OUD treatment engagement at 30 days after the ED visit, 198 participants (49.7%) who received ED buprenorphine treatment remained engaged compared with 15 participants (22.7%) who did not receive ED buprenorphine treatment. An association of ED buprenorphine treatment with subsequent OUD treatment engagement at 30 days was observed (adjusted risk ratio, 1.97 [95% CI, 1.27-3.07]).Conclusions and relevanceThe findings of this cohort study suggest that among patients with OUD presenting to EDs implementing low-threshold access to medications for OUD, buprenorphine treatment was associated with a substantially higher likelihood of follow-up treatment engagement 1 month later. Future research should investigate techniques to optimize both the uptake and effectiveness of buprenorphine initiation in low-threshold settings such as the ED.
| S-EPMC10825722 | biostudies-literature
Project description:ImportanceAgonist medications for opioid use disorder (MOUD), buprenorphine and methadone, in carceral settings might reduce the risk of postrelease opioid overdose but are uncommonly offered. In April 2019, the Massachusetts Department of Correction (MADOC), the state prison system, provided buprenorphine for incarcerated individuals in addition to previously offered injectable naltrexone.ObjectiveTo evaluate postrelease outcomes after buprenorphine implementation.Design, setting, and participantsThis cohort study with interrupted time-series analysis used linked data across multiple statewide data sets in the Massachusetts Public Health Data Warehouse stratified by sex due to differences in carceral systems. Eligible participants were individuals sentenced and released from a MADOC facility to the community. The study period for the male sample was January 2014 to November 2020; for the female sample, January 2015 to October 2019. Data were analyzed between February 2022 and January 2024.ExposureApril 2019 implementation of buprenorphine during incarceration.Main outcomes and measuresReceipt of MOUD within 4 weeks after release, opioid overdose, and all-cause mortality within 8 weeks after release, each measured as a percentage of monthly releases who experienced the outcome. Segmented linear regression analyzed changes in outcome rates after implementation.ResultsA total of 15 225 individuals were included. In the male sample there were 14 582 releases among 12 688 individuals (mean [SD] age, 35.0 [10.8] years; 133 Asian and Pacific Islander [0.9%], 4079 Black [28.0%], 4208 Hispanic [28.9%], 6117 White [41.9%]), a rate of 175.7 releases per month; the female sample included 3269 releases among 2537 individuals (mean [SD] age, 34.9 [9.8] years; 328 Black [10.0%], 225 Hispanic [6.9%], 2545 White [77.9%]), a rate of 56.4 releases per month. Among male participants at 20 months postimplementation, the monthly rate of postrelease buprenorphine receipt was higher than would have been expected under baseline trends (21.2% vs 10.6% of monthly releases; 18.6 additional releases per month). Naltrexone receipt was lower than expected (1.0% vs 6.0%; 8.8 fewer releases per month). Monthly rates of methadone receipt (1.4%) and opioid overdose (1.8%) were not significantly different than expected. All-cause mortality was lower than expected (1.9% vs 2.8%; 1.5 fewer deaths per month). Among female participants at 7 months postimplementation, buprenorphine receipt was higher than expected (31.6% vs 9.5%; 12.4 additional releases per month). Naltrexone receipt was lower than expected (3.4% vs 7.2%) but not statistically significantly different. Monthly rates of methadone receipt (1.1%), opioid overdose (4.8%), and all-cause mortality (1.6%) were not significantly different than expected.Conclusions and relevanceIn this cohort study of state prison releases, postrelease buprenorphine receipt increased and naltrexone receipt decreased after buprenorphine became available during incarceration.
| S-EPMC10949092 | biostudies-literature
Project description:BackgroundOpioid agonist therapy is strongly recommended for pregnant persons with opioid use disorder. Buprenorphine may be associated with more favorable neonatal and maternal outcomes than methadone, but existing data are limited.MethodsWe conducted a cohort study involving pregnant persons who were enrolled in public insurance programs in the United States during the period from 2000 through 2018 in which we examined outcomes among those who received buprenorphine as compared with those who received methadone. Exposure to the two medications was assessed in early pregnancy (through gestational week 19), late pregnancy (gestational week 20 through the day before delivery), and the 30 days before delivery. Risk ratios for neonatal and maternal outcomes were adjusted for confounders with the use of propensity-score overlap weights.ResultsThe data source for the study consisted of 2,548,372 pregnancies that ended in live births. In early pregnancy, 10,704 pregnant persons were exposed to buprenorphine and 4387 to methadone. In late pregnancy, 11,272 were exposed to buprenorphine and 5056 to methadone (9976 and 4597, respectively, in the 30 days before delivery). Neonatal abstinence syndrome occurred in 52.0% of the infants who were exposed to buprenorphine in the 30 days before delivery as compared with 69.2% of those exposed to methadone (adjusted relative risk, 0.73; 95% confidence interval [CI], 0.71 to 0.75). Preterm birth occurred in 14.4% of infants exposed to buprenorphine in early pregnancy and in 24.9% of those exposed to methadone (adjusted relative risk, 0.58; 95% CI, 0.53 to 0.62); small size for gestational age in 12.1% and 15.3%, respectively (adjusted relative risk, 0.72; 95% CI, 0.66 to 0.80); and low birth weight in 8.3% and 14.9% (adjusted relative risk, 0.56; 95% CI, 0.50 to 0.63). Delivery by cesarean section occurred in 33.6% of pregnant persons exposed to buprenorphine in early pregnancy and 33.1% of those exposed to methadone (adjusted relative risk, 1.02; 95% CI, 0.97 to 1.08), and severe maternal complications developed in 3.3% and 3.5%, respectively (adjusted relative risk, 0.91; 95% CI, 0.74 to 1.13). Results of exposure in late pregnancy were consistent with results of exposure in early pregnancy.ConclusionsThe use of buprenorphine in pregnancy was associated with a lower risk of adverse neonatal outcomes than methadone use; however, the risk of adverse maternal outcomes was similar among persons who received buprenorphine and those who received methadone. (Funded by the National Institute on Drug Abuse.).
| S-EPMC9873239 | biostudies-literature
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.
| S-EPMC8595679 | biostudies-literature