Treatment Journey and Healthcare Resource Use Among Patients With Alcohol Use Disorder Who Initiated Extended-Release Naltrexone: An Analysis of Veterans Affairs Data.

Background: The US Department of Veterans Affairs, Department of Defense (VA/DoD) clinical guidelines recommend extended-release naltrexone (XR-NTX) as a treatment option for moderate-to-severe alcohol use disorder (AUD); however, contemporary real-world outcomes related to this guideline are lacking. This retrospective, observational, descriptive study examined treatment patterns and healthcare resource use (HCRU) among veterans with an AUD diagnosis who initiated XR-NTX.

Methods: Veterans with incident AUD who initiated XR-NTX between 8/2014 and 11/2018 were identified.

Prescription opioid dispensing patterns among patients with schizophrenia or bipolar disorder.

Background: Patients with schizophrenia (SZ) or bipolar disorder (BD) may have increased risk of complications from prescribed opioids, including opioid-induced respiratory depression. We compared prescription opioid pain medication dispensing for patients with SZ or BD versus controls over 5 years to assess dispensing trends.

Methods: This retrospective, observational study analysed US claims data from the IBM® MarketScan® Commercial and Multi-State Medicaid databases for individuals aged 18-64 years with prevalent SZ or BD for years 2015-2019 compared with age- and sex-matched controls.

Characteristics and treatment preferences of individuals with opioid use disorder seeking to transition from buprenorphine to extended-release naltrexone in a residential setting.

Background And Objectives: Treatment for individuals receiving medication for opioid use disorder (MOUD) should follow an informed patient-centered approach. To better support patient autonomy in the decision-making process, clinicians should be aware of patient preferences and be prepared to educate and assist patients in transitioning from one MOUD to another, when clinically indicated. This posthoc analysis describes the characteristics of clinical trial participants (NCT02696434) with a history of opioid use disorder (OUD) seeking to transition from buprenorphine (BUP) to extended-release naltrexone (XR-NTX).

Patient characteristics associated with initiation of XR-naltrexone for opioid use disorder in clinical trials.

Background: Extended-release injectable naltrexone (XR-naltrexone) is effective for treatment of patients with opioid use disorder (OUD), but initiation remains a barrier due to the challenge of tolerating opioid withdrawal prior to administration. Understanding factors associated with successful initiation of XR-naltrexone could facilitate its implementation through patient-treatment matching.

Methods: We combined data from five consecutive studies that sought to initiate patients with active opioid use onto XR-naltrexone using a rapid procedure consisting of minimal buprenorphine, non-opioid medications for treating opioid withdrawal, and ascending low doses of oral naltrexone.

Patterns of withdrawal in patients with opioid use disorder (OUD) transitioning from untreated OUD or buprenorphine treatment to extended-release naltrexone.

Background: Pharmacologic treatment is recommended for many individuals with opioid use disorder (OUD). For patients who select opioid antagonist treatment, effective management of opioid withdrawal symptoms during transition to antagonist treatment requires consideration of the patient experience.

Objectives: To compare patterns of opioid withdrawal between those withdrawing from untreated opioid use and those withdrawing from buprenorphine.

Evaluation of Opioid Overdose Reports in Patients Treated with Extended-Release Naltrexone: Postmarketing Data from 2006 to 2018.

Introduction: After treatment with naltrexone extended-release injectable suspension (XR-NTX), a µ-opioid receptor antagonist, opioid tolerance is reduced from pretreatment baseline. Patients may be vulnerable to opioid overdose if they attempt to override the blockade during treatment, at the end of a dosing interval, after missing a dose, or after discontinuing treatment.

Objective: We analyzed postmarketing data to characterize reporting rates of opioid overdose during treatment with and after discontinuation of XR-NTX.

Cognitive performance of patients with opioid use disorder transitioned to extended-release injectable naltrexone from buprenorphine: Post hoc analysis of exploratory results of a phase 3 randomized controlled trial.

Background: Opioid use disorder (OUD) is associated with cognitive dysfunction. Understanding how pharmacotherapy may affect cognition is an important treatment consideration.

Methods: This was a hybrid residential-outpatient, randomized trial assessing transition regimens (naltrexone/buprenorphine [NTX/BUP] vs placebo-NTX/buprenorphine [PBO-N]/BUP) to extended-release naltrexone (XR-NTX) in patients with OUD seeking BUP discontinuation.

Transition of Patients with Opioid Use Disorder from Buprenorphine to Extended-Release Naltrexone: A Randomized Clinical Trial Assessing Two Transition Regimens.

Background And Objective: When patients seek to discontinue buprenorphine (BUP) treatment, monthly injectable extended-release naltrexone (XR-NTX) may help them avoid relapse. The efficacy of low ascending doses of oral NTX vs placebo for patients transitioning from BUP to XR-NTX is evaluated in this study.

Methods: In a phase 3, hybrid residential/outpatient study, clinically stable participants with opioid use disorder (N = 101), receiving BUP for more than or equal to 3 months and seeking antagonist treatment, were randomized (1:1) to 7 residential days of descending doses of BUP and low ascending doses of oral NTX (NTX/BUP, n = 50) or placebo (PBO-N/BUP, n = 51).

Opioid use and dropout from extended-release naltrexone in a controlled trial: implications for mechanism.

Background And Aims: Extended-release formulations of naltrexone have emerged as effective treatment options for opioid use disorder. This post-hoc analysis examined the temporal relationship between episodes of opioid use and subsequent dropout in a placebo-controlled trial of extended-release injection naltrexone (XR-NTX) to draw inferences about the mechanism by which extended blockade of opioid receptors translates into clinical effectiveness.

Design: This was a 24-week multiple-site, double-blind, randomized trial of monthly XR-NTX versus placebo injections.

Psychoeducational Strategies During Outpatient Transition to Extended-Release Naltrexone for Patients With Opioid Use Disorder.

The United States is experiencing an opioid epidemic. Better approaches to encourage outpatient utilization of Food and Drug Administration-approved medications for the treatment of opioid use disorder, including extended-release naltrexone (XR-NTX), are needed. Withdrawal management before initiation of XR-NTX is challenging for clinicians and patients and represents a major barrier to treatment.

A Randomized Trial Comparing Extended-Release Injectable Suspension and Oral Naltrexone, Both Combined With Behavioral Therapy, for the Treatment of Opioid Use Disorder.

Objective: The oral formulation of the opioid antagonist naltrexone has shown limited effectiveness for treatment of opioid use disorder due to poor adherence. Long-acting injection naltrexone (XR-naltrexone), administered monthly, circumvents the need for daily pill taking, potentially improving adherence, and has been shown to be superior to placebo in reducing opioid use over 6 months of treatment. This open-label trial compared the outcomes of patients with opioid use disorder treated with XR-naltrexone or oral naltrexone in combination with behavioral therapy.

Outpatient transition to extended-release injectable naltrexone for patients with opioid use disorder: A phase 3 randomized trial.

Background: Injectable extended-release naltrexone (XR-NTX), approved to prevent relapse to opioid dependence, requires initial abstinence. This multisite outpatient clinical trial examined the efficacy and safety of low-dose oral naltrexone (NTX), combined with a brief buprenorphine (BUP) taper and standing ancillary medications, for detoxification and induction onto XR-NTX.

Methods: Patients (N = 378) were randomized, stratified by primary short-acting opioid-of-use, to one of three regimens: NTX + BUP; NTX + placebo BUP (PBO-B); placebo NTX (PBO-N) + PBO-B.

Antagonists in the medical management of opioid use disorders: Historical and existing treatment strategies.

Background And Objectives: Opioid use disorder (OUD) is a chronic condition with potentially severe health and social consequences. Many who develop moderate to severe OUD will repeatedly seek treatment or interact with medical care via emergency department visits or hospitalizations. Thus, there is an urgent need to develop feasible and effective approaches to help persons with OUD achieve and maintain abstinence from opioids.

Extended-release naltrexone (XR-NTX) for opioid use disorder in clinical practice: Vivitrol's Cost and Treatment Outcomes Registry.

Background And Aims: Extended-release naltrexone (XR-NTX), a μ-opioid receptor antagonist for prevention of relapse to opioid dependence, has demonstrated efficacy compared with placebo and comparative effectiveness with buprenorphine-naloxone. We report outcomes for XR-NTX in Vivitrol's Cost and Treatment Outcomes Registry.

Design: Observational, open-label, single-arm, multi-center registry assessing baseline characteristics and clinical and health-related quality-of-life outcomes associated with XR-NTX treatment in clinical practice.

Effects of Ibudilast on the Subjective, Reinforcing, and Analgesic Effects of Oxycodone in Recently Detoxified Adults with Opioid Dependence.

Ibudilast, a nonselective phosphodiesterase inhibitor, is used clinically in Asia for the treatment of asthma and poststroke dizziness. Recent preclinical studies have suggested that it also inhibits glial cell activation in rodents, and may alter opioid-mediated effects, including analgesia and withdrawal symptoms. The effects of ibudilast on the abuse potential of opioids in humans are largely unknown.

A review of a national training initiative to increase provider use of MAT to address the opioid epidemic.

Background And Objectives: The Providers' Clinical Support System for Medication Assisted Treatment (PCSS-MAT) initiative focuses on training and mentoring health professionals in the treatment of opioid use disorders (OUD) using pharmacological strategies. Led by the American Academy of Addiction Psychiatry (AAAP), PCSS-MAT is a consortium representing four of the five national professional organizations authorized by DATA 2,000-AAAP, American Osteopathic Academy of Addiction Medicine, American Psychiatric Association, and American Society of Addiction Medicine. DATA organizations are authorized to train physicians to prescribe buprenorphine for OUD treatment.

Dronabinol and lofexidine for cannabis use disorder: A randomized, double-blind, placebo-controlled trial.

Background: Cannabis use disorder is associated with substantial morbidity and, after alcohol, is the most common drug bringing adolescents and adults into treatment. At present, there are no FDA-approved medications for cannabis use disorder. Combined pharmacologic interventions might be particularly useful in mitigating withdrawal symptoms and promoting abstinence.

The effects of pioglitazone, a PPARγ receptor agonist, on the abuse liability of oxycodone among nondependent opioid users.

Aims: Activation of PPARγ by pioglitazone (PIO) has shown some efficacy in attenuating addictive-like responses in laboratory animals. The ability of PIO to alter the effects of opioids in humans has not been characterized in a controlled laboratory setting. The proposed investigation sought to examine the effects of PIO on the subjective, analgesic, physiological and cognitive effects of oxycodone (OXY).

The effects of dronabinol during detoxification and the initiation of treatment with extended release naltrexone.

Background: Evidence suggests that the cannabinoid system is involved in the maintenance of opioid dependence. We examined whether dronabinol, a cannabinoid receptor type 1 partial agonist, reduces opioid withdrawal and increases retention in treatment with extended release naltrexone (XR-naltrexone).

Methods: Opioid dependent participants were randomized to receive dronabinol 30mg/d (n=40) or placebo (n=20), under double-blind conditions, while they underwent inpatient detoxification and naltrexone induction.

The effects of ibudilast, a glial activation inhibitor, on opioid withdrawal symptoms in opioid-dependent volunteers.

Glial activation is hypothesized to contribute directly to opioid withdrawal. This study investigated the dose-dependent effects of a glial cell modulator, ibudilast, on withdrawal symptoms in opioid-dependent volunteers after abrupt discontinuation of morphine administration. Non-treatment-seeking heroin-dependent volunteers (n = 31) completed the in-patient, double-blind, placebo-controlled, within-subject and between-group study.

Interviewing and Urine Drug Toxicology Screening in a Pediatric Pain Management Center: An Analysis of Analgesic Nonadherence and Aberrant Behaviors in Adolescents and Young Adults.

Objectives: Many adolescents and young adults report having chronic pain. Urine drug toxicology (UDT) is not routinely used in the pediatric pain management population, despite more routine use in adults with pain, particularly those prescribed opioids. As a first step toward establishing monitoring practices in pediatric and adolescent pain management, the present study evaluated the role of UDT in conjunction with a standard clinical interview in identifying the rate of adherence to an established analgesic regimen.

Opioid use and dropout in patients receiving oral naltrexone with or without single administration of injection naltrexone.

Background: Adherence to oral naltrexone has been poor and can be improved somewhat with behavioral therapy. We compared behavioral naltrexone therapy (BNT) to compliance enhancement (CE) and tested efficacy of single-dose injection naltrexone (XR-NTX; 384 mg) with behavioral therapies at further improving adherence to oral naltrexone.

Methods: A 24-week, randomized, placebo-controlled trial (n=125) compared four treatment conditions following inpatient detoxification and oral naltrexone induction: (1) BNT+XR-NTX; (2) BNT+placebo injection; (3) CE+XR-NTX; and (4) CE+placebo injection.