Injectable, Sustained-Release Naltrexone for the Treatment of Opioid Dependence

Comer, Sandra D.; Sullivan, Maria A.; Yu, Elmer; Rothenberg, Jami L.; Kleber, Herbert D.; Kampman, Kyle M.; Dackis, Charles A.; O’Brien, Charles P.

doi:10.1001/archpsyc.63.2.210

Cited by 313 publications

(296 citation statements)

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“…Very few patients appear to intentionally “override the blockade.” However, an attempt to override the blockade may lead to opioid intoxication or fatal opioid overdose, a fact that should be communicated to patients. Last, patients with OUD treated with XR‐NTX or naltrexone implant report reduced craving,53, 64, 70 an effect possibly related to blocking beta‐endorphin release in response to triggers or cues 89…”

Section: Current Approach To Treatment Of Opioid Use Disorder: Choosimentioning

confidence: 99%

“…Newer protocols focused on identifying optimal doses and treatment durations of buprenorphine, naltrexone, and clonidine to shorten induction periods, while minimizing the severity of withdrawal. Major changes to earlier protocols involved reducing buprenorphine treatment to 1–2 days, shortening to 1 day the “washout” period before starting naltrexone, and decreasing the first dose of naltrexone from 12.5 to 3 mg, with supportive medications, usually standing doses of clonidine and clonazepam administered at frequent dosing intervals 51, 52, 53, 54, 55, 56, 57. A 2017 study comparing outpatient detoxification regimens showed that an oral naltrexone‐assisted detoxification regimen, compared with a descending buprenorphine taper followed by a 7‐day washout period, was more likely to lead to successful XR‐NTX induction (56% vs. 33%) and a second XR‐NTX dose (50% vs. 27%) 58…”

Section: Historical Perspective On Clinical Management Of Opioid Withmentioning

confidence: 99%

“…Poor adherence to daily oral medication spurred the development of extended‐release injectable and implantable formulations that would eliminate the need for daily decisions to take a medication 53, 63, 64, 65, 66, 67…”

Section: Historical Perspective On Clinical Management Of Opioid Withmentioning

confidence: 99%

“…Patients treated with XR‐NTX (implants or injectable) have less treatment dropout, lower rates of opioid use, and reduced craving, as compared with patients treated with placebo 53, 64, 70. Persons on probation or parole who were randomly assigned to an open‐label treatment with XR‐NTX compared with treatment as usual had significantly lower rates of relapse, longer relapse‐free survival, lower rates of heroin use, and fewer overdoses over a 24‐week treatment period, with a loss of effect seen at 28 and 54 weeks after the end of treatment 71.…”

Section: Historical Perspective On Clinical Management Of Opioid Withmentioning

confidence: 99%

“…Up to one third of patients who receive XR‐NTX use illicit opioids at some point during treatment, commonly as single episodes to “test” the blocking effect of the medication 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 62. A recent study of patients using opioids during XR‐NTX blockade found that most did not feel euphoria and used lower doses than before receiving XR‐NTX.…”

Section: Current Approach To Treatment Of Opioid Use Disorder: Choosimentioning

confidence: 99%

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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: Current Approach To Treatment Of Opioid Use Disorder: Choosimentioning

confidence: 99%

Section: Historical Perspective On Clinical Management Of Opioid Withmentioning

confidence: 99%

Section: Historical Perspective On Clinical Management Of Opioid Withmentioning

confidence: 99%

Section: Historical Perspective On Clinical Management Of Opioid Withmentioning

confidence: 99%

Section: Current Approach To Treatment Of Opioid Use Disorder: Choosimentioning

confidence: 99%

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

et al. 2018

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Improving Clinical Outcomes in Treating Heroin Dependence

Hulse¹,

Morris²,

Arnold-Reed³

et al. 2009

Arch Gen Psychiatry

113

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Randomized Trial of Long-Acting Sustained-Release Naltrexone Implant vs Oral Naltrexone or Placebo for Preventing Relapse to Opioid Dependence

Krupitsky

Zvartau²,

Blokhina³

et al. 2012

Arch Gen Psychiatry

115

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Context Sustained-release naltrexone implants may improve outcomes of nonagonist treatment of opioid addiction. Objective To compare outcomes of naltrexone implants, oral naltrexone hydrochloride, and nonmedication treatment. Design Six-month double-blind, double-dummy, randomized trial. Setting Addiction treatment programs in St Petersburg, Russia. Participants Three hundred six opioid-addicted patients recently undergoing detoxification. Interventions Biweekly counseling and 1 of the following 3 treatments for 24 weeks: (1) 1000-mg naltrexone implant and oral placebo (NI+OP group; 102 patients); (2) placebo implant and 50-mg oral naltrexone hydrochloride (PI+ON group; 102 patients); or (3) placebo implant and oral placebo (PI+OP group; 102 patients). Main Outcome Measure Percentage of patients retained in treatment without relapse. Results By month 6, 54 of 102 patients in the NI+OP group (52.9%) remained in treatment without relapse compared with 16 of 102 patients in the PI+ON group (15.7%) (survival analysis, log-rank test, P<.001) and 11 of 102 patients in the PI+OP group (10.8%) (P<.001). The PI+ON vs PI+OP comparison showed a nonsignificant trend favoring the PI+ON group (P=.07). Counting missing test results as positive, the proportion of urine screening tests yielding negative results for opiates was 63.6% (95% CI, 60%-66%) for the NI+OP group; 42.7% (40%-45%) for the PI+ON group; and 34.1% (32%-37%) for the PI+OP group (P<.001, Fisher exact test, compared with the NI+OP group). Twelve wound infections occurred among 244 implantations (4.9%) in the NI+OP group, 2 among 181 (1.1%) in the PI+ON group, and 1 among 148 (0.7%) in the PI+OP group (P=.02). All events were in the first 2 weeks after implantation and resolved with antibiotic therapy. Four local-site reactions (redness and swelling) occurred in the second month after implantation in the NI+OP group (P=.12), and all resolved with antiallergy medication treatment. Other nonlocal-site adverse effects were reported in 8 of 886 visits (0.9%) in the NI+OP group, 4 of 522 visits (0.8%) in the PI+ON group, and 3 of 394 visits (0.8%) in the PI+ON group; all resolved and none were serious. No evidence of increased deaths from overdose after naltrexone treatment ended was found. Conclusions The implant is more effective than oral naltrexone or placebo. More patients in the NI+OP than in the other groups develop wound infections or local irritation, but none are serious and all resolve with treatment.

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Injectable, Sustained-Release Naltrexone for the Treatment of Opioid Dependence

Abstract: These data provide new evidence of the feasibility, efficacy, and tolerability of long-lasting antagonist treatments for opioid dependence.

Cited by 313 publications

References 39 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

Improving Clinical Outcomes in Treating Heroin Dependence

Randomized Trial of Long-Acting Sustained-Release Naltrexone Implant vs Oral Naltrexone or Placebo for Preventing Relapse to Opioid Dependence

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