Addiction/dependence Archives - MPR Wed, 03 Apr 2024 13:30:28 +0000 en-US hourly 1 https://wordpress.org/?v=6.4.3 https://www.empr.com/wp-content/uploads/sites/7/2023/03/cropped-empr-32x32.jpg Addiction/dependence Archives - MPR 32 32 Acamprosate https://www.empr.com/drug/acamprosate/ Thu, 22 Jul 2021 10:58:46 +0000 https://www.empr.com/drug/campral/ ACC: Binge Drinking Further Increases CVD Risk With High Alcohol Consumption https://www.empr.com/home/news/acc-binge-drinking-further-increases-cvd-risk-with-high-alcohol-consumption/ Wed, 03 Apr 2024 13:00:00 +0000 https://www.empr.com/?p=218123 Link between alcohol and heart disease appears to be especially strong among women.

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HealthDay News — High levels of alcohol consumption are associated with increased cardiovascular disease (CVD) risk among men and women aged 65 years and younger, with even higher risk seen among those who also “binge” drink, according to a study presented at the annual meeting of the American College of Cardiology, held from April 6 to 8 in Atlanta.

Jamal S. Rana, MD, PhD, from Kaiser Permanente Northern California in Oakland, and colleagues examined whether or not heavy episodic drinking days (HED; i.e., “binge” drinking), in conjunction with habitual drinking, impacts CVD risk among US adults. The analysis included 697,985 adults (43% women) who, in 2014 to 2015, reported drinking alcohol as part of regular health care screening.

The researchers found that for men and women (aged 18 to 65 years), those with high total consumption (≥15 drinks/week for men; 8 or more drinks/week for women) had higher odds of CVD compared with those with moderate (3 to 14 drinks/week for men; 3 to 7 drinks/week for women) or low (1 to 2 drinks/week for men or women) consumption. Associations were stronger among those reporting any HED (5 or more drinks on any day in past 3 months for men and 4 or more for women; 20.8%). For men older than 65 years, CVD risk was not increased with or without HED. For women older than 65 years and HED, moderate and high total consumptions more than doubled the odds of CVD vs that seen with low consumption.

“Women feel they’re protected against heart disease until they’re older, but this study shows that even when you’re young or middle aged, if you are a heavy alcohol user or binge drink, you are at risk for coronary heart disease,” Rana said in a statement.

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Adaptation to Pharmacotherapy Does Not Up Smoking Cessation in Black Adults https://www.empr.com/home/news/adaptation-to-pharmacotherapy-does-not-up-smoking-cessation-in-black-adults/ Wed, 28 Jun 2023 13:00:00 +0000 https://www.empr.com/?p=199729

No significant difference in verified 7-day abstinence seen by treatment group among Black adults who smoke daily.

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HealthDay News — For Black adults who smoke, adaptation to varenicline and/or bupropion plus nicotine patch (NP) does not improve abstinence rates compared with NP monotherapy, according to a study published online June 20 in JAMA Network Open.

Nicole L. Nollen, PhD, from the University of Kansas School of Medicine in Kansas City, and colleagues examined the efficacy of multiple smoking cessation pharmacotherapy adaptations based on treatment response in Black adults who smoke daily in a randomized clinical trial of adapted therapy (ADT) or enhanced usual care (UC). Both groups received 18 weeks of pharmacotherapy with follow-up through week 26. The ADT group included 196 individuals who received an NP and up to two pharmacotherapy adaptations (varenicline at week 2 and bupropion at week 6 if needed), while the UC group included 196 individuals who received NP throughout.

The researchers observed no significant difference in verified 7-day abstinence by treatment group at 12, 18, or 26 weeks. Of the 71.8% of the ADT participants who received pharmacotherapy adaptations, 8.1% were abstinent at week 12. Controlling for treatment, individuals who responded to treatment and had carbon monoxide-verified abstinence at week 2 had significantly increased odds of being abstinent at week 12 compared to those who did not respond to treatment (28.7 vs 7.8%; odds ratio, 4.6).

“Findings highlight the continued need to identify effective treatment, particularly for those at high risk for cessation failure and those disproportionately impacted by tobacco-related disease,” the authors write.

Several authors disclosed financial ties to industry.

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AHA: Daily Marijuana Use Linked to Incident Heart Failure https://www.empr.com/home/news/aha-daily-marijuana-use-linked-to-incident-heart-failure/ Mon, 13 Nov 2023 14:00:00 +0000 https://www.empr.com/?p=210168 And, cannabis use disorder linked to increased odds of major adverse cardiac and cerebrovascular events.

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HealthDay News — Daily marijuana use is associated with incident heart failure, and cannabis use disorder (CUD) is associated with increased odds of major adverse cardiac and cerebrovascular events (MACCE), according to 2 studies presented at the American Heart Association Scientific Sessions 2023, held from November 11 to 13 in Philadelphia.

Yakubu Bene-Alhasan, MD, MPH, from Medstar Health in Baltimore, and colleagues used data from the National Institutes of Health “All of Us” Research Program to examine the association between the frequency of marijuana use and new-onset heart failure. The researchers found there were 2958 events within a median follow-up of 45 months from a final population of 156,999 patients. Daily marijuana use was associated with an increased risk for incident heart failure compared with never use (adjusted hazard ratio, 1.34; 95% CI interval, 1.04 to 1.72). After the addition of coronary artery disease diagnosis as a time-varying covariate in the main model, the association was attenuated and no longer significant (adjusted hazard ratio, 1.27; 95% CI, 0.99 to 1.62).

Avilash Mondal, MD, from Nazareth Hospital in Philadelphia, and colleagues examined the association between CUD in elderly nonsmokers with established cardiovascular disease risk and MACCE. The researchers found that 13.9% of 28,535 elderly cannabis users reported MACCE episodes. Compared with the non-CUD cohort, the CUD cohort reported higher MACCE (odds ratio, 1.20), all-cause mortality, dysrhythmia, acute myocardial infarction, transfer to other facilities, and home health care. In CUD users, chronic lung disease, renal disease, hypertension, and hyperlipidemia were predictors of MACCE episodes.

“The main public message is to be more aware of the increased risks and open the lines of communication so that cannabis use is acknowledged and considered,” Mondal said in a statement.

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Almost Linear Association Seen Between Alcohol Intake, Blood Pressure https://www.empr.com/home/news/almost-linear-association-seen-between-alcohol-intake-blood-pressure/ Tue, 01 Aug 2023 13:00:00 +0000 https://www.empr.com/?p=201515 man holding a glass

Baseline alcohol intake associated with systolic BP changes in men and women, diastolic BP in men.

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HealthDay News — There is an almost linear association between alcohol intake and blood pressure (BP) in healthy adults, according to a review published online July 31 in Hypertension.

Silvia Di Federico, from the University of Modena and Reggio Emilia in Italy, and colleagues conducted a systematic review of studies conducted in healthy adults that reported on the association between alcohol intake and BP. The analysis included seven studies with 19,548 participants and a median follow-up of 5.3 years.

The researchers identified a substantially linear positive association between baseline alcohol intake and changes over time in systolic BP (SBP) and diastolic BP (DBP), with no indication of an exposure-effect threshold. Compared with no consumption, average SBP was 1.25 and 4.90 mm Hg higher and average DBP was 1.14 and 3.10 mm Hg higher for 12 or 48 g daily alcohol consumption, respectively. An almost linear association was seen between baseline alcohol intake and SBP changes in both men and women and for DBP in men, while an inverted U-shaped association was identified in women. In both Asians and North Americans, alcohol intake was positively associated with BP change, apart from DBP in North Americans.

“Future research should assess the association in women and in different age groups, both of which are currently characterized by limited availability of relevant data,” the authors write.

One author disclosed receiving speaker’s fees from Bayer, Daiichi Sankyo, Janssen, and Sanofi.

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BRIXADI https://www.empr.com/drug/brixadi/ Tue, 05 Sep 2023 18:34:22 +0000 https://www.empr.com/drug/brixadi/ Buprenorphine Weekly (8mg/0.16mL, 16mg/0.32mL, 24mg/0.48mL, 32mg/0.64mL); Monthly (64mg/0.18mL, 96mg/0.27mL, 128mg/0.36mL); ext-rel; soln for SC inj.]]> ]]> Brixadi Now Available for Weekly or Monthly Administration to Treat Opioid Use Disorder https://www.empr.com/home/news/brixadi-now-available-for-weekly-or-monthly-administration-to-treat-opioid-use-disorder/ Tue, 05 Sep 2023 15:45:00 +0000 https://www.empr.com/?p=206198 Brixadi (weekly) and Brixadi (monthly) are different formulations. ]]>

Brixadi® (buprenorphine) extended-release subcutaneous injection is now available for the treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. Brixadi should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Brixadi contains buprenorphine, a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. The approval was based on data from a phase 3 trial (ClinicalTrials.gov Identifier: NCT02651584) that compared the long-acting subcutaneous treatment to an existing standard of care, sublingual buprenorphine/naloxone, in patients with moderate to severe OUD. 

Brixadi is available in either a weekly or monthly formulation for subcutaneous injection into the buttock, thigh, abdomen, or upper arm. The weekly injection can be administered to patients who have tolerated a single 4mg dose of a transmucosal buprenorphine‐containing product or those who are currently being treated with a transmucosal buprenorphine-containing product; injection sites should be alternated/rotated between injections. The monthly injection is appropriate for patients who are currently being treated with a transmucosal buprenorphine-containing product. 

The most common adverse reactions reported with Brixadi were injection site reactions (eg, pain, erythema, pruritus), headache, constipation, nausea, insomnia, and urinary tract infection. Brixadi carries a Boxed Warning associated with a risk for serious harm or death if the product is administered intravenously. Because of this risk, Brixadi is only available through a Risk Evaluation and Mitigation Strategy (REMS) program; treatment should be administered only in a health care setting by a health care provider who is certified in the REMS program.

Brixadi, a Schedule III controlled substance, is supplied as prefilled single-dose syringes in weekly (8mg/0.16mL, 16mg/0.32mL, 24mg/0.48mL, 32mg/0.64mL) and monthly (64mg/0.18mL, 96mg/0.27mL, 128mg/0.36mL) doses. Doses of Brixadi (weekly) cannot be combined to yield an equivalent Brixadi (monthly) dose. The product does not require refrigeration.

“Brixadi is designed to align with how health care providers treat patients with OUD by offering multiple weekly and monthly dosing options to meet the patient where they are in their treatment journey,” said Paul Johnson, Chief Commercial Officer at Braeburn. “Health care providers and their patients with OUD will now have another FDA-approved option for long-acting, extended-release buprenorphine to address some of the challenges associated with the disease.”

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Buprenorphine Sublingual Tablets https://www.empr.com/drug/buprenorphine-sublingual-tablets/ Wed, 03 Jan 2024 13:43:20 +0000 https://www.empr.com/drug/buprenorphine-sublingual-tablets/ Buprenorphine-Naloxone Appears Safe for Maternal Opioid Use Disorder https://www.empr.com/home/news/buprenorphine-naloxone-appears-safe-for-maternal-opioid-use-disorder/ Tue, 17 Jan 2023 14:00:00 +0000 https://www.empr.com/?p=190333

Maternal, neonatal outcomes similar to buprenorphine monotherapy

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HealthDay News — Buprenorphine-naloxone seems to be as safe for pharmacotherapy for maternal opioid use disorder as buprenorphine monotherapy, according to a study published online January 11 in Acta Obstetricia et Gynecologica Scandinavica.

Minna M. Kanervo, from the University of Helsinki in Finland, and colleagues followed 67 pregnant women on medical-assisted opioid maintenance treatment from conception to delivery to compare the outcomes of the pregnancies, deliveries, and newborns.

The researchers found that the buprenorphine-naloxone and buprenorphine groups showed similar outcomes and did not significantly differ from each other in terms of maternal health during pregnancies, deliveries, or newborns. Among all groups, illicit drug use during pregnancy was common, but in the methadone group it was most prevalent. The vast majority of neonates (96%) were born full-term with good Apgar scores. Newborns had relatively small birth size, with those in the methadone group tending to be the smallest. Nearly two-thirds of the neonates (63%) needed pharmacological treatment for neonatal opioid withdrawal syndrome, with lower need seen in the buprenorphine-based groups versus the methadone group.

“Combination therapy of buprenorphine and naloxone could be a choice for oral opioid maintenance treatment during pregnancy, but larger studies are needed before changing the official recommendations,” Kanervo said in a statement.

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CDC: 2018 to 2021 Saw Increase in Drug Overdose Deaths Involving Xylazine https://www.empr.com/home/news/cdc-2018-to-2021-saw-increase-in-drug-overdose-deaths-involving-xylazine/ Wed, 05 Jul 2023 13:00:00 +0000 https://www.empr.com/?p=199992

Increase seen in age-adjusted rate of drug overdose deaths involving xylazine from 0.03 to 1.06 per 100,000 standard population.

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HealthDay News — From 2018 to 2021, there was an increase in the age-adjusted rate of drug overdose deaths involving xylazine, from 0.03 to 1.06 per 100,000 standard population, according to a June Vital Statistics Rapid Release report, a publication from the US Centers for Disease Control and Prevention.

Merianne Rose Spencer, MPH, from the National Centers for Health Statistics in Hyattsville, Maryland, and colleagues identified drug overdose deaths involving xylazine for US residents from 2018 through 2021 overall and by sex.

The researchers found that from 2018 to 2021, the age-adjusted rate of drug overdose deaths involving xylazine increased from 0.03 to 1.06 per 100,000 standard population. For each year between 2018 and 2021, the rates for males were at least twice that of females. The rates increased across all age group and reportable race and Hispanic origin categories between 2020 and 2021. Rates were highest among those aged 25 to 34 and 35 to 44 in 2020, while in 2021, the highest rates were seen for those aged 35 to 44. The highest rates were seen among non-Hispanic Black or African American people in 2020 and 2021 (0.68 and 1.82, respectively). However, compared with other groups, the largest increases in rates occurred among Hispanic or Latino people (0.21 and 0.64 in 2020 and 2021, respectively). The most frequently co-occurring drug mentioned on xylazine death records between 2018 and 2021 was fentanyl.

“This study highlights the increase in drug overdose deaths involving xylazine since 2018,” the authors write. “Overall, the age-adjusted rate of drug overdose deaths involving xylazine increased 35 times.”

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DAAs Less Likely for Hep C Patients With Alcohol Use Disorder https://www.empr.com/home/news/daas-less-likely-for-hep-c-patients-with-alcohol-use-disorder/ Thu, 05 Jan 2023 14:00:00 +0000 https://www.empr.com/?p=189955 Hepatitis C virus in liver, human body

Those with current alcohol use disorder or abstinent with alcohol use disorder history had lower likelihood of receiving direct-acting antivirals

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Hepatitis C virus in liver, human body

HealthDay News — For patients with hepatitis C virus (HCV), those with current alcohol use disorder (AUD) or a history of AUD are less likely to receive direct-acting antiviral (DAA) treatment, according to a study published online December 14 in JAMA Network Open.

Lamia Y. Haque, MD, MPH, from the Yale School of Medicine in New Haven, Connecticut, and colleagues examined the association between alcohol use and receipt of DAA treatment among patients with HCV in a cohort study involving 133,753 HCV patients born from 1945 to 1965.

Overall, 38% of the patients had current AUD, 12% were abstinent with a history of AUD, 6% reported at-risk drinking, 14% reported lower-risk drinking, and 30% were abstinent with no history of AUD. The researchers found that DAA treatment receipt within one year was 7, 33, 53, and 56% for those entering the cohort in 2014, 2015, 2016, and 2017, respectively. For those entering the cohort in 2014, the likelihood of receiving DAA treatment within one year was lower for those with current AUD or abstinent with an AUD history compared with those with lower-risk drinking (hazard ratios [95% CI], 0.72 [0.66 to 0.77] and 0.91 [0.84 to 1.00], respectively). For those entering in 2015 to 2017, the corresponding hazard ratios (95% CI) were 0.75 (0.70 to 0.81) and 0.76 (0.68 to 0.86).

“Given the higher risk of liver-related complications, DAA treatment should be prioritized for patients with HCV and unhealthy alcohol use,” the authors write.

One author disclosed financial ties to Playbl, which distributes video games for risk prevention, including substance use, in youth.

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Deaths Due to Opioid Toxicity Up in US During COVID-19 https://www.empr.com/home/news/deaths-due-to-opioid-toxicity-up-in-us-during-covid-19/ Wed, 12 Jul 2023 13:03:00 +0000 https://www.empr.com/?p=200419

Years of life lost due to opioid toxicity plateaued between 2017 and 2019, then increased through 2021.

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HealthDay News — Deaths due to opioid toxicity increased during the COVID-19 pandemic, according to a study published online July 7 in JAMA Network Open.

Tara Gomes, PhD, from St. Michael’s Hospital in Toronto, and colleagues characterized the societal burden of unintended opioid-related deaths in the US. The proportion of all deaths that were attributable to unintentional opioid toxicity were examined by year and age group. In addition, the total years of life lost (YLL) due to unintentional opioid toxicity was estimated, overall, and by sex and age group.

Data were included for 422,605 unintentional deaths due to opioid toxicity between 2011 and 2021. The researchers found that there was a 289% increase in the number of unintentional deaths due to opioid toxicity, from 19,395 to 75,477. From 2011 to 2021, the percentage of all deaths that were attributed to opioid toxicity increased from 1.8 to 4.5%. By 2021, opioid toxicity was responsible for 10.2, 21.7, and 21.0% of deaths among those aged 15 to 19, 20 to 29, and 30 to 39 years, respectively. Over the study period, the YLL due to opioid toxicity increased 276%. YLL plateaued between 2017 and 2019 (7.0 and 7.2 YLL per 1000) but then increased by 62.9% between 2019 and 2021, reaching 11.7 YLL per 1000.

“The crisis of deaths due to opioid toxicity across the U.S. worsened substantially during the COVID-19 pandemic, with 1 in 22 deaths in 2021 attributable to unintentional opioid toxicity,” the authors write

One author disclosed past employment with Sanofi Pasteur.

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Diazepam Injection https://www.empr.com/drug/diazepam-injection/ Fri, 17 Feb 2023 19:51:34 +0000 https://www.empr.com/drug/diazepam-injection/ Disulfiram https://www.empr.com/drug/disulfiram/ Mon, 15 Aug 2022 16:28:37 +0000 https://www.empr.com/drug/antabuse/ E-Cigarette Use Prevalence Increased in Younger Adults From 2019 to 2021 https://www.empr.com/home/news/e-cigarette-use-prevalence-increased-in-younger-adults-from-2019-to-2021/ Wed, 19 Apr 2023 13:00:00 +0000 https://www.empr.com/?p=195439 e-cigarette teenager

Increase in prevalence mainly due to increase among never smokers, who accounted for 53% of younger adult e-cigarette users in 2021.

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e-cigarette teenager

HealthDay News — For younger adults, the prevalence of electronic cigarette (e-cigarette) use increased from 2019 to 2021, especially among those who never smoked cigarettes, according to a study published online April 18 in the American Journal of Preventive Medicine.

Priti Bandi, PhD, from the American Cancer Society in Atlanta, and colleagues estimated current e-cigarette use prevalence using data from cross-sectional, nationally representative National Health Interview Surveys in 2019, 2020, and 2021 by age group (younger, 18 to 29 years; middle age, 30 to 44 and 45 to 59 years; and older, 60 years and older) and by cigarette smoking status.

The researchers found that between 2019 and 2021, there was an increase in the prevalence of e-cigarette use among younger adults (8.8 to 10.2%; adjusted prevalence difference, 1.7%), mainly due to an increase among never smokers (4.9 to 6.4%; adjusted prevalence difference, 1.7%). Of the younger adults who used e-cigarettes in 2021, people who never smoked cigarettes constituted 53%. The prevalence was similar in 2019 and 2021 among middle-age and older adults, regardless of cigarette smoking status; the largest proportion of people who used e-cigarettes in 2021 was made up of those who formerly smoked cigarettes (51.8, 51.6, and 47.5% among those aged 30 to 44, 45 to 59, and 60 years and older, respectively).

“We must address the rise in e-cigarette use among younger adults who never smoked cigarettes and, at the same time, help those who may have switched from cigarettes to e-cigarettes to stop using these devices completely,” Bandi said in a statement.

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E-Cigarettes, Cytisine, Varenicline Most Effective to Help Stop Smoking https://www.empr.com/home/news/e-cigarettes-cytisine-varenicline-most-effective-to-help-stop-smoking/ Mon, 18 Sep 2023 13:00:00 +0000 https://www.empr.com/?p=206817

Combination of a patch and fast-acting nicotine replacement therapy also effective.

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HealthDay News — Electronic cigarettes and the medicines cytisine and varenicline appear to help the most people to quit smoking, according to a review published online September 12 in the Cochrane Library.

Nicola Lindson, PhD, from University of Oxford in the United Kingdom, and colleagues investigated the comparative benefits, harms, and tolerability of different smoking cessation pharmacotherapies and e-cigarettes to help people stop smoking tobacco.

Based on 319 randomized controlled trials (157,179 participants), the researchers found with high-certainty evidence that nicotine e-cigarettes (odds ratio, 2.37; 16 trials), varenicline (odds ratio, 2.33; 67 trials), and cytisine (odds ratio, 2.21; 7 trials) were associated with higher quit rates than control, each yielding an additional 7 or 8 quitters per 100. The combination of nicotine replacement therapy (patch plus a fast-acting form) was also effective (odds ratio, 1.93). Overall, the rates of serious adverse events were low (average, 3%) for treatments, excluding nortriptyline and non-nicotine e-cigarettes. Removing the 104 studies at high risk for bias did not alter the results.

“More head-to-head comparisons of the most effective interventions are needed, as are tests of combinations of these,” the authors write. “Future work should unify data from behavioral and pharmacological interventions to inform approaches to combined support for smoking cessation.”

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Emergency Department-Administered Buprenorphine Is Safe, Effective https://www.empr.com/home/news/emergency-department-administered-buprenorphine-is-safe-effective/ Thu, 06 Apr 2023 13:00:00 +0000 https://www.empr.com/?p=194765

Among patients experiencing precipitated withdrawal, all were discharged after symptoms resolved, with one self-directed discharge.

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HealthDay News — Buprenorphine induction in the emergency department is safe and effective, even for fentanyl use, according to a research letter published online March 30 in JAMA Network Open.

Gail D’Onofrio, MD, from the Yale School of Medicine in New Haven, Connecticut, and colleagues evaluated the incidence of precipitated withdrawal (PW) as part of an ongoing randomized clinical trial comparing traditional sublingual buprenorphine with CAM2038, a 7-day extended-release injectable form of buprenorphine. The analysis included 1200 patients seen at 28 emergency departments (June 30, 2020, to October 26, 2022).

The researchers identified 9 cases of PW (0.76% of the overall sample), and of these, 5 received sublingual buprenorphine and four received extended-release buprenorphine. There was variance in routes of use, changes in baseline and peak Clinical Opiate Withdrawal Scale scores, and time elapsed from buprenorphine administration to PW, but all patients had urine tests positive for fentanyl. There was a range in time since last use from 8 to less than 24 hours. Among patients experiencing PW, all were discharged after symptoms resolved, with one self-directed discharge. The majority (86%) had follow-up rates at 7 days after the emergency department visit.

“Continued access to buprenorphine for opioid use disorder treatment is essential given the ongoing overdose crisis,” the authors write.

Two authors disclosed financial ties to the pharmaceutical industry.

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Extended-Release Buprenorphine Not Necessarily Cost-Effective https://www.empr.com/home/news/extended-release-buprenorphine-not-necessarily-cost-effective/ Tue, 19 Sep 2023 13:03:00 +0000 https://www.empr.com/?p=206953

Extended-release buprenorphine not cost-effective when transmucosal buprenorphine is available for treatment of OUD.

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HealthDay News — For patients with opioid use disorder (OUD), treatment with extended-release buprenorphine is not cost-effective when transmucosal buprenorphine is available, according to a study published online September 13 in JAMA Network Open.

Juliet M. Flam-Ross, from Boston Medical Center, and colleagues examined the cost-effectiveness of extended-release buprenorphine vs transmucosal buprenorphine. The evaluation simulated the lifetime of a closed cohort of 100,000 individuals with OUD receiving or not receiving opioid agonist treatment with buprenorphine.

The researchers found that treatment with transmucosal buprenorphine yielded an incremental cost-effectiveness ratio of $19,740 per quality-adjusted life year (QALY) compared with no medication treatment. Treatment with extended-release versus transmucosal buprenorphine yielded lower effectiveness by 0.03 QALYs per person at higher cost. Transmucosal buprenorphine was the preferred strategy 60% of the time in probabilistic sensitivity analyses. Compared with treatment with transmucosal buprenorphine, treatment with extended-release buprenorphine was cost-effective at a willingness-to-pay threshold of $100,000 per QALY only after substantial changes in key parameters.

“The ongoing nationwide surge in opioid overdose deaths underscores the need for a broad menu of effective treatments to address the diverse needs of all patients,” the authors write. “Our findings on important thresholds in two key parameters, namely cost and retention, might be helpful to policy makers.”

One author disclosed ties to industry.

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FDA Approves Brixadi, a New Treatment Option for Opioid Use Disorder https://www.empr.com/home/news/brixadi/ Wed, 24 May 2023 19:10:00 +0000 https://www.empr.com/?p=197358 Brixadi is supplied as prefilled single-dose syringes in weekly (8mg, 16mg, 24mg, 32mg) and monthly (64mg, 96mg, 128mg) doses.]]>

The Food and Drug Administration (FDA) has approved Brixadi™ (buprenorphine) extended-release subcutaneous injection for the treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with a transmucosal buprenorphine-containing product.

Brixadi contains buprenorphine, a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor; it is supplied in 2 formulations. The weekly injection can be administered to patients who have tolerated a single 4mg dose of a transmucosal buprenorphine‐containing product or those who are currently being treated with a transmucosal buprenorphine-containing product. The monthly injection is appropriate for patients who are currently being treated with a transmucosal buprenorphine-containing product. Brixadi should be used as part of a complete treatment plan that includes counseling and psychosocial support.

The approval was based on data from a phase 3 trial (ClinicalTrials.gov Identifier: NCT02651584) that compared the long-acting subcutaneous treatment to an existing standard of care, sublingual buprenorphine/naloxone, in 428 patients with moderate to severe OUD. Patients were randomly assigned to receive Brixadi plus a sublingual placebo, or active sublingual buprenorphine plus placebo injections, following an initial test dose of transmucosal buprenorphine.

Following titration over the first week, patients were treated with weekly injections over 12 weeks and then switched to monthly injections for an additional 12 weeks. The primary endpoint was the response rate at week 24. Patients were considered responders if they had negative opioid assessments (urinalysis and self-report) at the end of each of the 2 treatment phases.

Results showed that Brixadi met the primary endpoint of noninferiority for responder rate vs daily sublingual buprenorphine/naloxone (16.9% v 14.0%, respectively; P <.001). Treatment with Brixadi also met a key secondary endpoint demonstrating superiority to sublingual buprenorphine/naloxone in the percentage of negative opioid assessments from week 4 to 24 (P =.004). 

The most common adverse reactions reported with Brixadi were injection site reactions (eg, pain, erythema, pruritus), headache, constipation, nausea, insomnia, and urinary tract infection. The prescribing information for Brixadi includes a Boxed Warning associated with a risk for serious harm or death if the product is administered intravenously. Due to this risk, Brixadi is only available through a Risk Evaluation and Mitigation Strategy (REMS) program; treatment should be administered only in a health care setting by a health care provider who is certified in the REMS program.

Brixadi, a Schedule III controlled substance, is supplied as prefilled single-dose syringes in weekly (8mg/0.16mL, 16mg/0.32mL, 24mg/0.48mL, 32mg/0.64mL) and monthly (64mg/0.18mL, 96mg/0.27mL, 128mg/0.36mL) doses. Doses of Brixadi (weekly) cannot be combined to yield an equivalent Brixadi (monthly) dose.

The product is expected to be available in September 2023.

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Fibromyalgia Is Risk Factor for Opioid Use Disorder Exacerbations https://www.empr.com/home/news/fibromyalgia-is-risk-factor-for-opioid-use-disorder-exacerbations/ Thu, 20 Apr 2023 13:00:00 +0000 https://www.empr.com/?p=195466

New instrument, the Pain-related OUD Exacerbation Scale, shows validity

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HealthDay News — Fibromyalgia is a risk factor for pain-related exacerbation of opioid use disorder (OUD), according to a study published online March 14 in PAIN.

Orman Trent Hall, DO, from the Ohio State University Wexner Medical Center in Columbus, and colleagues examined interactions between fibromyalgia and OUD using data from 125 individuals (31% with fibromyalgia) recruited from an academic substance use treatment facility. The 2011 American College of Rheumatology Fibromyalgia Survey, along with an original scale measuring pain-related OUD exacerbation (Pain-related OUD Exacerbation Scale [PrOUD ES]), was administered through an electronic survey. The authors also tested the efficacy of PrOUD ES.

The researchers found that patients with fibromyalgia demonstrated significantly greater odds of acknowledging pain-related OUD exacerbations. Furthermore, participants with fibromyalgia acknowledged putting off seeking help out of fear their pain would be unbearable if they stopped using opioids. Additionally, the PrOUD ES had a single-factor solution, strong internal consistency, and construct validity.

“The present work provides evidence of the factor structure, validity, and reliability of a new scale to measure pain-related OUD exacerbations: PrOUD ES,” the authors write. “Given great scientific interest in the intersection of pain and OUD embodied by the National Institutes of Health Helping to End Addiction Long-term initiative, PrOUD ES warrants further study as a patient-reported outcome measure of potential importance.”

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Higher Buprenorphine Dose Increases Likelihood of Staying in Treatment https://www.empr.com/home/news/higher-buprenorphine-dose-increases-likelihood-of-staying-in-treatment/ Fri, 22 Sep 2023 13:01:00 +0000 https://www.empr.com/?p=207123

Findings reported for patients seeking treatment for opioid use disorder from 2016 to 2020.

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HealthDay News — Patients initiating buprenorphine treatment for opioid use disorder who are prescribed a 24mg dose are more likely to remain in treatment longer than those prescribed 16mg, according to a study published online September 18 in JAMA Network Open.

Laura C. Chambers, PhD, from Brown University in Providence, Rhode Island, and colleagues estimated the association between buprenorphine dose and time to treatment discontinuation during a period of widespread fentanyl availability. The analysis included 6499 patients initiating buprenorphine treatment for opioid use disorder (October 1, 2016, to September 30, 2020).

The researchers found that more than half of patients were prescribed a daily dose (16mg or 24mg) at initiation (16mg: 50%; 24mg: 10%). Nearly 6 in 10 patients (58%) discontinued buprenorphine treatment within 180 days (16mg: 59%; 24mg: 53%). Patients prescribed a dose of 16mg had a greater risk for treatment discontinuation than those prescribed 24mg (adjusted hazard ratio, 1.20).

“The results of this study suggest that the value of higher buprenorphine doses than currently recommended needs to be considered for improving retention in treatment,” the authors write.

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Increase in Percentage of OD Deaths From 2020 to 2022 Involving Smoking https://www.empr.com/home/news/increase-in-percentage-of-od-deaths-from-2020-to-2022-involving-smoking/ Fri, 16 Feb 2024 14:00:00 +0000 https://www.empr.com/?p=215676 During the same time period, there was a decrease seen in the percentage of overdose deaths with evidence of injection.

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HealthDay News — From 2020 to 2022, there was an increase in the percentage of overdose deaths with evidence of smoking, according to research published in the February 15 issue of the US Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.

Lauren J. Tanz, ScD, from the CDC in Atlanta, and colleagues describe trends in routes of drug use in 27 states and the District of Columbia among overdose deaths occurring during January 2020 to December 2022.

The researchers found that from January-June 2020 to July-December 2022, there was a 29.1% decrease in the percentage of overdose deaths with evidence of injection, from 22.7 to 16.1%, and a 73.7% increase in the percentage with evidence of smoking, from 13.3 to 23.1%. A 109.1% increase was seen in the number of deaths with evidence of smoking, from 2,794 to 5,843; smoking was the most commonly documented route of use in overdose deaths by 2022. In all US regions, the trends were similar. Among deaths with only illegally manufactured fentanyl and fentanyl analogs (IMFs), there was a 41.6% decrease in the percentage with evidence of injection (from 20.9 to 12.2%) and a 78.9% increase in the percentage with evidence of smoking (from 10.9 to 19.5%). Among deaths with both IMFs and stimulants detected, similar trends were seen.

“Although unsafe injection drug use practices might be most risky in terms of infectious disease transmission, other routes, particularly smoking, still carry substantial overdose risk,” the authors write.

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LUCEMYRA https://www.empr.com/drug/lucemyra/ Thu, 22 Jul 2021 11:47:41 +0000 https://www.empr.com/drug/lucemyra/ LUCEMYRALofexidine (as HCl) 0.18mg; tabs.]]> LUCEMYRA]]> Meds Rarely Initiated After Discharge for Alcohol Use Disorder https://www.empr.com/home/news/meds-rarely-initiated-after-discharge-for-alcohol-use-disorder/ Wed, 05 Jul 2023 13:00:00 +0000 https://www.empr.com/?p=199954

Strongest demographic predictor for discharge initiation of medications for alcohol use disorder was younger age.

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HealthDay News — Patients hospitalized for alcohol use disorder (AUD) rarely initiate medications for AUD (MAUD) after discharge, according to a research letter published online June 27 in the Annals of Internal Medicine.

Eden Y. Bernstein, MD, from Massachusetts General Hospital in Boston, and colleagues characterized MAUD treatment initiation after AUD hospitalizations using a sample of Medicare Parts A, B, and D beneficiaries with continuous enrollment 12 months before and after cohort entry. A total of 28,601 AUD hospitalizations representing 20,401 unique patients were included in the cohort.

Overall, 206 and 364 patients initiated MAUD treatment within 2 and 30 days of discharge, respectively (0.7 and 1.3%). Of patients with a primary discharge diagnosis of AUD, 2.3% initiated MAUD treatment within 2 days of discharge. The researchers found that younger age was the most predictive demographic factor for discharge initiation of MAUD treatment (adjusted odds ratio, 3.87 for age 18 to 39 vs ≥75 years). Absence of self-directed discharge, psychiatric hospital, or psychiatry or addiction medicine inpatient care vs no addiction medicine or psychiatry, and a primary discharge diagnosis of AUD were the strongest hospitalization predictors (adjusted odds ratios, 18.48, 9.80, 6.23, and 4.75, respectively). Remote MAUD use, female sex, psychiatric disorders, and lower Elixhauser index were additional predictors. Similar predictors were seen for the outcome of MAUD treatment initiation within 30 days.

“Our findings highlight missed opportunities for MAUD treatment initiation among the high-risk group of patients with AUD who are hospitalized,” the authors write.

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Methadone https://www.empr.com/drug/methadone/ Thu, 05 Aug 2021 19:24:42 +0000 https://www.empr.com/drug/dolophine/