A Phase 4, Pilot, Open-Label Study of VIVITROL® (Extended-Release Naltrexone XR-NTX) for Prisoners

Gordon, Michael S.; Kinlock, Timothy W.; Vocci, Frank; Fitzgerald, Terrence T.; Memişoğlu, Aslı; Silverman, Bernard L.

doi:10.1016/j.jsat.2015.07.005

Cited by 41 publications

(44 citation statements)

References 38 publications

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“…However, there is limited experience with this drug medication outside specialized treatment settings. XR‐NTX has frequently been offered to patients who have completed extended residential treatment15 and to patients for whom initiation of relapse‐prevention treatment with XR‐NTX was relatively uncomplicated because of current abstinence 16. Most patients in need of treatment, however, are actively using opioids at the time of initial evaluation and require completion of opioid withdrawal before XR‐NTX initiation.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2018

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Background and ObjectivesOpioid 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. Treatment that includes one of the three FDA‐approved medications is an evidence‐based strategy to manage OUD. The purpose of this review is to address practices for managing persons with moderate to severe OUD with a focus on opioid withdrawal and naltrexone‐based relapse‐prevention treatment.MethodsLiterature available on PubMed was used to review the evolution of treatment strategies from the 1960s onward to manage opioid withdrawal and initiate treatment with naltrexone.ResultsEmerging practices for extended‐release naltrexone induction include the use of agonist tapers and adjuvant medications. Clinical challenges frequently encountered when initiating this therapy include managing withdrawal and ongoing opioid use during treatment. Clinical factors may inform decisions regarding patient selection and length of naltrexone treatment, such as recent opioid use and patient preferences.Conclusions and Scientific SignificanceTreatment strategies to manage opioid withdrawal have evolved, but many patients with OUD do not receive medication for the prevention of relapse. Clinical strategies for induction onto extended‐release naltrexone are now available and can be safely and effectively implemented in specialty and select primary care settings. (© 2018 The Authors. The American Journal on Addictions Published by Wiley Periodicals, Inc. on behalf of The American Academy of Addiction Psychiatry (AAAP);27:177–187)

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Section: Introductionmentioning

confidence: 99%

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

et al. 2018

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“…Based on preliminary data from the research team's current studies that individuals receiving long-acting naltrexone at a community treatment or opioid clinic, adherence rates begin to decrease by month four, 32,49,60 it is anticipated XR-NTX+MMTx condition will have superior outcomes compared to the XR-NTX+OTx condition in terms of outcomes: a) XR-NTX treatment adherence; b) opioid use; c) criminal activity; d) re-arrest; e) reincarceration; and f) HIV risk-behaviors (i. needle use; ii. risky sexual behaviors).…”

Section: Methodsmentioning

confidence: 99%

“…We designed this effectiveness study based on the disparate injection adherence and retention differences seen in the Lee et al 45 and the Gordon et al 49 studies in which parolees and probationers had greater treatment adherence than newly-released prisoners, respectively. Thus, our interest was not in whether XR-NTX worked in this population, but to address the unanswered question of whether mobile medical services (XR-NTX) will increase medication adherence in the newly-released population, thereby reducing opioid use, HIV risk behaviors, re-arrest, and reincarceration.…”

Section: Design Considerationsmentioning

confidence: 99%

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Extended-release naltrexone for pre-release prisoners: A randomized trial of medical mobile treatment

Gordon

Vocci

Fitzgerald

et al. 2017

Contemporary Clinical Trials

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Background Extended-release naltrexone (XR-NTX), is an effective treatment for opioid use disorder but is rarely initiated in US prisons or with criminal justice populations. Mobile treatment for chronic diseases have been implemented in a variety of settings. Mobile treatment may provide an opportunity to expand outreach to parolees to surmount barriers to traditional clinic treatment. Methods Male and female prisoners (240) with pre-incarceration histories of opioid use disorder who are within one month of release from prison will be enrolled in this randomized clinical trial. Participants are randomized to one of two study arms: 1) [XR-NTX-OTx] One injection of long-acting naltrexone in prison, followed by 6 monthly injections post-release at a community opioid treatment program; or 2) [XR-NTX+ MMTx] One injection of long-acting naltrexone in prison followed by 6 monthly injections post-release at the patient's place of residence utilizing mobile medical treatment. The primary outcomes are: treatment adherence; opioid use; criminal activity; re-arrest; reincarceration; and HIV risk-behaviors. Results We describe the background and rationale for the study, its aims, hypotheses, and study design. Conclusions The use of long-acting injectable naltrexone may be a promising form of treatment for pre-release prisoners. Finally, as many individuals in the criminal justice system drop out of treatment, this study will assess whether treatment at their place of residence will improve adherence and positively affect treatment outcomes.

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“…This prevents the abused opioids from producing their physiological effects, even if taken. The provision of injectable extended-release naltrexone has recently become available in some prison settings and its use as an addiction and health-focused criminal justice intervention eliminates several problems that complicate the use of more traditionally used MATs in prison facilities (Gordon et al, 2015).…”

Section: Medication-assisted Treatment 1964-presentmentioning

confidence: 99%

An historical review of racial bias in prison-based substance abuse treatment design

Kerrison

2017

Journal of Offender Rehabilitation

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This study leverages critical race and legal epidemiological frameworks to illustrate the race-based historical evolution of U.S. rehabilitation paradigms directed at imprisoned heroin and opioid users. What began as a racist early-20th-century federal antinarcotic trafficking effort has since assumed a state-based treatment agenda whose programmatic operations are largely based in correctional settings disproportionately reserved for poor substance abusers of color. Even in contemporary carceral facilities, where incarcerated populations are teeming with White addicts, in the aggregate, White drug abusers have been protected from the depraved, incorrigible, and inherently pathological drug-using caricature assigned to their non-White counterparts. This historical examination demonstrates how links between broader drug policy and prison-based drug treatment support a legally codified White supremacist narrative that erodes health and wellbeing for program participants of color, and the communities to which they inevitably return.

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A Phase 4, Pilot, Open-Label Study of VIVITROL® (Extended-Release Naltrexone XR-NTX) for Prisoners

Cited by 41 publications

References 38 publications

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

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

Extended-release naltrexone for pre-release prisoners: A randomized trial of medical mobile treatment

An historical review of racial bias in prison-based substance abuse treatment design

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