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Serious adverse events reported in placebo randomised controlled trials of oral naltrexone: a systematic review and meta-analysis

Monica Bolton, Alex Hodkinson, Shivani Boda, Alan Mould, Maria Panagioti, Sarah Rhodes, Lisa Riste and Harm van Marwijk

BMC Medicine2019, 17:10, doi.org/10.1186/s12916-018-1242-0


No increased pain among opioid-dependent individuals treated with extended-release naltrexone or buprenorphine-naloxone: A 3-month randomized study and 9-month open-treatment follow-up study.

Latif ZE, Solli KK, Opheim A, Kunoe N, Benth JŠ, Krajci P, Sharma-Haase K, Tanum L.

Am J Addict. 2019 Jan 31. doi: 10.1111/ajad.12859. 



Effectiveness, safety and feasibility of extended release naltrexone for opioid dependence: a nine month follow up to a three month randomized trial.

Solli, K. K., Latif, Z., Opheim, A., Krajci, P., SharmaHaase, K., Benth, Jė. Š., Tanum, L., and Kunoe, N. (2018

Addiction, doi: 10.1111/add.14278.



Drug combo shows promise in treatment of depression and addiction

The combination of naltrexone and ketamine can help treat both symptoms of addiction and depression, a preliminary study by Yale University researchers suggests. (Yale News, USA, 09.01.2019)


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

Bisaga A, Mannelli P, Yu M, Nangia N, Graham CE, Tompkins DA, Kosten TR, Akerman SC, Silverman BL, Sullivan MA.

Drug Alcohol Depend. 2018 Apr 10;187:171-178. doi: 10.1016/j.drugalcdep.2018.02.023



Singh D, Saadabadi A.

StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2018 Jan-.2018 Nov 27., PMID: 30521232


USA. Trump Opioid Plan Writes in Favoritism to Single Company’s Addiction Medication

The White House’s national strategy to combat the opioid crisis, unveiled last week, would expand a particular kind of addiction treatment in federal criminal justice settings: a single drug, manufactured by a single company, with mixed views on the evidence regarding its use.

Federal prisons should “facilitate naltrexone treatment and access to treatment” to inmates as they transition out of incarceration, according to a fact sheet circulated by the administration. A White House spokesman later confirmed to STAT that the document referred specifically to naltrexone in its injectable form.

Only one manufacturer makes a drug fitting that description: Alkermes, a Massachusetts pharmaceutical company that makes Vivitrol, a monthly injectable drug that blocks the effects of opioids and reduces cravings. (ATForum, USA, 06.04.2018)


Anxiety, Depression, and Insomnia Among Adults With Opioid Dependence Treated With Extended-Release Naltrexone vs Buprenorphine-Naloxone: A Randomized Clinical Trial and Follow-up Study. 

Latif Z, Šaltytė Benth J, Solli KK, et al. 

JAMA Psychiatry.Published online December 19, 2018. doi:10.1001/jamapsychiatry.2018.3537



Review of Case Narratives from Fatal Overdoses Associated with Injectable Naltrexone for Opioid Dependence.

Saucier R, Wolfe D, Dasgupta N.

Drug Saf. 2018 Mar 20. doi: 10.1007/s40264-018-0653-3.



Analysis of Evidence for the Combination of Pro-dopamine Regulator (KB220PAM) and Naltrexone to Prevent Opioid Use Disorder Relapse.

Blum K, Modestino EJ, Badgaiyan RD, Baron D, Thanos PK, Elman I, Siwicki D, Febo M, Gold MS.

EC Psychol Psychiatr. 2018 Aug;7(8):564-579. 


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

Bisaga A, Mannelli P, Sullivan MA, Vosburg SK, Compton P, Woody GE, Kosten TR.

Am J Addict. 2018 Apr;27(3):177-187. doi: 10.1111/ajad.12711. Review.


Long-acting naltrexone has long-acting benefits and 100% induction rates are not difficult to achieve.

Brewer, C., and Streel, E. (2018) 

Addiction, doi.org/10.1111/add.14448.


Feasibility and safety of extended-release naltrexone treatment of opioid and alcohol use disorder in HIV clinics: a pilot/feasibility randomized trial.

Korthuis PT, Lum PJ, Vergara-Rodriguez P, Ahamad K, Wood E, Kunkel LE, Oden NL, Lindblad R, Sorensen JL, Arenas V, Ha D, Mandler RN, McCarty D; CTN-0055 CHOICES Investigators.

Addiction. 2017 Jun;112(6):1036-1044. doi: 10.1111/add.13753.


Extended-release injectable naltrexone (XR-NTX): A response to clinical issues raised by Brewer and Streel.

Jarvis, B. P., Holtyn, A. F., Subramaniam, S., Tompkins, A. D., Oga, E. A., Bigelow, G., and Silverman, K. (2018) 

Addiction, https://doi.org/10.1111/add.14462.


Extended-release injectable naltrexone for opioid use disorder: A systematic review.

Jarvis BP, Holtyn AF, Subramaniam S, Tompkins DA, Oga EA, Bigelow GE, Silverman K.

Addiction. 2018 Feb 3. doi: 10.1111/add.14180.



Blocking drug activation as a therapeutic strategy to attenuate acute toxicity and physiological effects of heroin.

Zhang T, Zheng X, Kim K, Zheng F, Zhan CG.

Sci Rep. 2018 Nov 13;8(1):16762. doi: 10.1038/s41598-018-35196-8.


Naltrexone for Opioid Use Disorders: A Review.

Source: CADTH Report / Project in Briefs [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2011-.
2017 Aug.

Excerpt: With the potential advantages of XR-NTX compared with oral naltrexone in patients with opioid use disorder, there is a need to determine whether XR-NTX is a viable treatment option. A review of the clinical effectiveness, cost-effectiveness, and guidelines for injectable and oral naltrexone to treat opioid use disorder will help inform decisions regarding treatment options for managing opioid dependence.


Low-Dose Naltrexone (LDN)-Review of Therapeutic Utilization.

Toljan K, Vrooman B.

Med Sci (Basel). 2018 Sep 21;6(4). pii: E82. doi: 10.3390/medsci6040082.


Managing severe pain and abuse potential: the potential impact of a new abuse-deterrent formulation oxycodone/naltrexone extended-release product.

Pergolizzi JV Jr, Taylor R Jr, LeQuang JA, Raffa RB.

J Pain Res. 2018 Feb 8;11:301-311. doi: 10.2147/JPR.S127602.


Ethics and evidence on naltrexone treatment of offenders

Drugs&Alcohol Findings, UK, 2018

Effects of extended-release naltrexone on the brain response to drug-related stimuli in patients with opioid use disorder.

Shi Z, Wang AL, Jagannathan K, Fairchild VP, O'Brien CP, Childress AR, Langleben DD.

J Psychiatry Neurosci. 2018 Feb 23;43(3):170036. doi: 10.1503/jpn.170036.



SAMHSA. Medications for opioid use disorder: for healthcare and addiction professionals, policymakers, patients, and families: Treatment Improvement Protocol: TIP 63.

Substance Abuse and Mental Health Services Administration 
[US] Substance Abuse and Mental Health Services Administration, 2018


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

Saxon AJ, Akerman SC, Liu CC, Sullivan MA, Silverman BL, Vocci FJ.

Addiction. 2018 Mar 1. doi: 10.1111/add.14199.



High drug related mortality rates following prison release: Assessing the acceptance likelihood of a naltrexone injection and related concerns.

Murphy PN, Mohammed F, Wareing M, Cotton A, McNeill J, Irving P, Jones S, Sharples L, Monk R, Elton P.

J Subst Abuse Treat. 2018 Sep;92:91-98. doi: 10.1016/j.jsat.2018.07.002.



Nicotine-Use/Smoking Is Associated with the Efficacy of Naltrexone in the Treatment of Alcohol Dependence.

Anton RF, Latham PK, Voronin KE, Randall PK, Book SW, Hoffman M, Schacht JP.

Alcohol Clin Exp Res. 2018 Feb 12. doi: 10.1111/acer.13601.




Excerpt: Limited data indicate that naltrexone is minimally excreted into breastmilk. If naltrexone is required by the mother, it is not a reason to discontinue breastfeeding.


- Drug Levels and Effects

- Substance Identification

- Administrative Information

Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-.


Injectable Extended-Release Naltrexone to Treat Opioid Use Disorder.

Ndegwa S, Pant S, Pohar S, Mierzwinski-Urban M.

CADTH Issues in Emerging Health Technologies. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2016-. 163.


Naltrexon (Naltrexin®)

Naltrexon eignet sich für ein kleines Segment hochmotivierter entgifteter opioidabhängiger Patienten, ohne aktuellen Opioidkonsum (weder im Rahmen einer SGB oder als illegaler Konsum). Polytoxikomanie ist eine Kontraindikation! (fosumos - Praxis Suchtmedizin Schweiz, aktualisiert am 18.05.2018)


USA. SAMHSA publishes guidance on clinical best practices using medication-assisted treatment to combat the opioid epidemic

The Substance Abuse and Mental Health Services Administration (SAMHSA) is publishing guidance today to help broaden healthcare professionals’ understanding of medications that can be used to treat Americans with opioid use disorder (OUD).

“We know that people can and do recover from opioid use disorders when they receive appropriate treatment, and medication-assisted treatment’s success in treating opioid use disorders is well documented,” said Dr. Elinore F. McCance-Katz, Assistant Secretary for Mental Health and Substance Use. “TIP 63 emphasizes that increasing access to medications to treat opioid use disorder will help more people recover, enabling them to improve their health, living full and productive lives.”

The Treatment Improvement Protocol (TIP) 63, “Medications for Opioid Use Disorder,” reviews the use of the three Food and Drug Administration-approved medications to treat opioid use disorders: methadone, naltrexone, and buprenorphine. Mandated by Section 303 of the Comprehensive Addiction and Recovery Act (P.L. 114-198), this TIP provides guidance for healthcare professionals and addiction treatment providers on appropriate prescribing practices for these medications and effective strategies for supporting the patients utilizing medication for the treatment of OUD. TIP 63 also educates patients, families, and the general public about how OUD medications work and the benefits they offer. The Substance Abuse and Mental Health Services Administration (SAMHSA), 15.02.2018)


Acceptability of Extended-Release Naltrexone by Heroin-Dependent Patients and Addiction Treatment Providers in the Netherlands.

Zaaijer ER, Goudriaan AE, Koeter MW, Booij J, van den Brink W.

Subst Use Misuse. 2016 Dec 5;51(14):1905-11. doi: 10.1080/10826084.2016.1201117.