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Beneficial Effects of Opioid Rotation to Buprenorphine/Naloxone on Opioid Misuse, Craving, Mental Health, and Pain Control in Chronic Non-Cancer Pain Patients with Opioid Use Disorder.

ABSTRACT: Patients with chronic non-cancer pain (CNCP) often use opioids for long periods of time. This may lead to opioid use disorder (OUD) and psychiatric symptoms: mainly depression and anxiety. The current study investigated the effect of buprenorphine/naloxone (BuNa) rotation on opioid misuse, craving, psychiatric symptoms and pain in patients with CNCP and OUD. Forty-three participants with CNCP and OUD were converted from a full mu-receptor agonist opioid (mean morphine equivalent dose: 328.3 mg) to BuNa, in an inpatient setting. Opioid misuse, craving, co-occurring psychiatric symptoms, and pain perception were determined at baseline and after a two-month follow-up, using the following self-report questionnaires: Current Opioid Misuse Measurement (COMM), Visual Analog Scale (VAS-craving and VAS-pain) and Depression, Anxiety and Stress Scale (DASS), respectively. VAS-craving and VAS-pain were also determined immediately after conversion. A total of 37 participants completed the protocol. The mean COMM decreased from 17.1 to 6.7 (F = 36.5; p < 0.000), the mean VAS-craving decreased from 39.3 to 5.3 (-86.6%; F = 26.5, p < 0.000), the mean DASS decreased from 12.1 to 6.6 (F = 56.3, p < 0.000), and the mean VAS-pain decreased from 51.3 to 37.2 (-27.4%, F = 3.3; p = 0.043). Rotation to BuNa in patients with CNCP and OUD was accompanied by reductions in (i) opioid misuse, (ii) opioid craving, (iii) the severity of co-occurring psychiatric symptoms, and (iv) self-reported pain. BuNa as opioid agonist treatment may therefore be a beneficial strategy in CNCP patients with OUD. The limited sample size and the observational nature of this study underline the need for the replication of the current findings in large-scale, controlled studies.

SUBMITTER: Schellekens AFA

PROVIDER: S-EPMC8396821 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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.

Project description:Importance:Buprenorphine treatment for opioid use disorder may be improved by sustained-release formulations. Objective:To determine whether treatment involving novel weekly and monthly subcutaneous (SC) buprenorphine depot formulations is noninferior to a daily sublingual (SL) combination of buprenorphine hydrochloride and naloxone hydrochloride in the treatment of opioid use disorder. Design, Setting, and Participants:This outpatient, double-blind, double-dummy randomized clinical trial was conducted at 35 sites in the United States from December 29, 2015, through October 19, 2016. Participants were treatment-seeking adults with moderate-to-severe opioid use disorder. Interventions:Randomization to daily SL placebo and weekly (first 12 weeks; phase 1) and monthly (last 12 weeks; phase 2) SC buprenorphine (SC-BPN group) or to daily SL buprenorphine with naloxone (24 weeks) with matched weekly and monthly SC placebo injections (SL-BPN/NX group). Main Outcomes and Measures:Primary end points tested for noninferiority were response rate (10% margin) and the mean proportion of opioid-negative urine samples for 24 weeks (11% margin). Responder status was defined as having no evidence of illicit opioid use for at least 8 of 10 prespecified points during weeks 9 to 24, with 2 of these at week 12 and during month 6 (weeks 21-24). The mean proportion of samples with no evidence of illicit opioid use (weeks 4-24) evaluated by a cumulative distribution function (CDF) was an a priori secondary outcome with planned superiority testing if the response rate demonstrated noninferiority. Results:A total of 428 participants (263 men [61.4%] and 165 women [38.6%]; mean [SD] age, 38.4 [11.0] years) were randomized to the SL-BPN/NX group (n = 215) or the SC-BPN group (n = 213). The response rates were 31 of 215 (14.4%) for the SL-BPN/NX group and 37 of 213 (17.4%) for the SC-BPN group, a 3.0% difference (95% CI, -4.0% to 9.9%; P < .001). The proportion of opioid-negative urine samples was 1099 of 3870 (28.4%) for the SL-BPN/NX group and 1347 of 3834 (35.1%) for the SC-BPN group, a 6.7% difference (95% CI, -0.1% to 13.6%; P < .001). The CDF for the SC-BPN group (26.7%) was statistically superior to the CDF for the SL-BPN/NX group (0; P = .004). Injection site adverse events (none severe) occurred in 48 participants (22.3%) in the SL-BPN/NX group and 40 (18.8%) in the SC-BPN group. Conclusions and Relevance:Compared with SL buprenorphine, depot buprenorphine did not result in an inferior likelihood of being a responder or having urine test results negative for opioids and produced superior results on the CDF of no illicit opioid use. These data suggest that depot buprenorphine is efficacious and may have advantages. Trial Registration:ClinicalTrials.gov Identifier: NCT02651584.

Project description:BackgroundMedicaid presently insures about one-fourth of the US population and disproportionately insures about 38 % of non-elderly adults with an opioid use disorder (OUD). Owing to Medicaid's prominent role insuring persons with an OUD and that Medicaid coverage includes pharmaceutical benefits, there has been considerable interest in studying potential prescription opioid misuse among Medicaid beneficiaries and identifying subpopulations at higher risk for misuse and possible progression to an OUD.MethodsThe study goals were to explore the associations among prescription opioid misuse, OUD, and co-occurring mental health and other substance use disorders (SUD). We analyzed Illinois Medicaid 2018 claims data for 1102479 adult beneficiaries 18 to 64 years of age. Using algorithms based on previous studies, we first determined either the presence or absence of nine SUDS (including OUD), nine mental health disorders and likely prescription opioid misuse. Then, we subdivided the beneficiary sample into five groups: those who were prescribed opioids and evidenced either no, possible, or probable misuse; those evidencing an OUD; and those evidencing no opioid use or misuse.ResultsBivariate analyses, upset plots, and multinomial logistic regressions were used to compare the five subgroups on the prevalence of co-occurring SUDS and mental health disorders. Those with an OUD or with probable prescription opioid misuse had the highest prevalence of most co-occurring conditions with beneficiaries with an OUD the most likely to evidence co-occurring SUDS, particularly tobacco use disorder, whereas those with probable misuse had elevated prevalence rates of co-occurring mental health disorders comparable to those with an OUD.ConclusionThe medical complexity of persons with an OUD or misusing prescription opioids are considered in light of recent attempts to expand buprenorphine provision as a medication for OUD among Medicaid beneficiaries. Additionally, we consider the possibility of gender, co-occurring mental health disorders, and tobacco use disorder as important risk factors for progressing to prescription opioid misuse and an OUD.

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Beneficial Effects of Opioid Rotation to Buprenorphine/Naloxone on Opioid Misuse, Craving, Mental Health, and Pain Control in Chronic Non-Cancer Pain Patients with Opioid Use Disorder.

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