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Clinical Policy Bulletin:
Ultra Rapid Detoxification (UROD)
Number: 0317


Policy

Aetna considers ultra rapid detoxification (UROD) experimental and investigational as a clinical detoxification treatment and for all other indications because its effectiveness has not been established.



Background

Detoxification, although important, is only the first step in long-term relapse prevention treatment of opiate addiction.  Proven detoxification procedures presently involve a gradual withdrawal followed by medication and long-term psychosocial support in producing long-term abstinence from illicit opioid use.

In the ultra rapid detoxification (UROD) procedure, opiate detoxification is induced by the use of a bolus injection of very high doses of an opiate antagonist (naloxone) under general anesthesia or heavy sedation followed by a slow infusion of low-dose naloxone.  The 4-hour procedure is carried out in an intensive care unit and the patient requires 1 to 2 days of hospitalization for a full treatment protocol.  Proponents of the procedure claim that complete accelerated detoxification is attained, the patient experiences no withdrawal symptoms, physical dependency is eliminated, and the psychological craving for drugs is greatly reduced.  However, experts prominent in the field of opiate addiction in 1996 reported their concerns about UROD stating that detoxification is not a cure for opiate addiction and that medication without psychosocial support has little impact on opiate addiction.

There is no scientifically-based evidence in the medical literature to substantiate that UROD is safe and effective as a clinical detoxification treatment.  There is a reported risk of serious adverse events, including death with the use of anesthetics, making the risk:benefit ratio of this detoxification procedure unacceptable.  Besides direct causality associated with inadvertent anesthetic over-dose, there is also the risk of indirect causality related to possible aspiration and choking from emesis that may occur when an anesthetized or heavily sedated individual is detoxified while asleep.

To date, only 1 double-blind study and few research reports have systematically documented the nature of the UROD procedure and its safety and efficacy for both immediate detoxification and longer term relapse prevention.  No double-blind studies indicate that ultra-short detoxification procedures are more successful in decreasing relapse to opiates than longer duration treatments.

The California Technology Assessment Forum (CTAF, 2002) has determined that rapid and ultra rapid opiate detoxification does not meet CTAF's assessment criteria.  The CTAF assessment concluded: "Existing published studies of rapid detoxification and ultra rapid detoxification have raised the prospect of new approaches to opioid detoxification.  However, methodological limitations limit the generalizability of the studies, and thus these techniques, to widespread clinical application.  Lack of randomization and blinding, sample size variations, different clinical profiles of studied patients, and diverse pharmacologic treatment used and clinical settings, preclude comparisons between studies and the drawing of any firm conclusions regarding the efficacy and safety of these procedures.  The post-detoxification relapse rate for these techniques appears to be quite variable.  The most suitable patients for these procedures must still be defined.  Both rapid and ultra rapid opioid detoxification must undergo further scientific evaluation in randomized, controlled trials to determine whether their clinical effectiveness and safety outweigh their risks.  Further research is also warranted to evaluate longer-term outcomes and compare these methods with other treatments for opioid addiction such as methadone maintenance supervised methadone taper, naltrexone maintenance, counseling-supported abstinence, and toxicological surveillance."

A structured evidence review by Gowing et al (2010) reached the following conclusions about UROD: "Heavy sedation compared to light sedation does not confer additional benefits in terms of less severe withdrawal or increased rates of commencement on naltrexone maintenance treatment.  Given that the adverse events are potentially life-threatening, the value of antagonist-induced withdrawal under heavy sedation or anaesthesia is not supported.  The high cost of anaesthesia-based approaches, both in monetary terms and use of scarce intensive care resources, suggest that this form of treatment should not be pursued."

An UpToDate review on “Opioid detoxification during treatment for addiction” (Weaver and Hopper, 2013) states that “Serious complications have been reported with anesthesia-assisted rapid detoxification, and a randomized trial did not find it to be superior to buprenorphine-assisted rapid detoxification, or clonidine-assisted detoxification.  In this study, the three detoxification strategies resulted in no differences in rates of completion of inpatient detoxification or completion of the treatment program at 12 weeks; the overall dropout rate was 82 percent.  There were three serious adverse events, all occurring in the anesthesia group.  A systematic review of five randomized trials found that the potential serious harms and costs of heavy sedation or anesthesia, and lack of benefit from this procedure, do not support this method of detoxification.  We believe that ultrarapid opiate detoxification is not a medically sound therapy and should be avoided."

Guidelines from the National Institute for Health and Clinical Excellence (2007) state: "Ultra-rapid and rapid detoxification using precipitated withdrawal should not be routinely offered. This is because of the complex adjunctive medication and the high level of nursing and medical supervision required." The guidelines also state: "Ultra-rapid detoxification under general anaesthesia or heavy sedation (where the airway needs to be supported) must not be offered. This is because of the risk of serious adverse events, including death."

 
CPT Codes / HCPCS Codes / ICD-9 Codes
There is no specific code for ultra rapid detoxification:
HCPCS codes not covered for indications listed in CPB:
J2310 Injection, naloxone HCl, per 1 mg
ICD-9 codes not covered for indications listed in CPB:
304.00 - 304.03 Opioid type dependence
305.50 - 305.53 Opioid abuse
965.00 - 965.09 Poisoning by opiates and related narcotics
E935.1 Adverse effects of methadone
E935.2 Adverse effects of other opiates and related narcotics


The above policy is based on the following references:
  1. National Institute on Drug Abuse (NIDA). NIDA Scientific Report of Ultra Rapid Detoxification with Anesthesia (UROD): Opinion of the Consultants and Criteria Relating to Evaluating the Safety and Efficiency of UROD. Bethesda, MD: National Institutes of Health (NIH); February 23, 1996.
  2. Mannelli P, De Risio S, Pozzi G, et al. Serendipitous rapid detoxification from opiates: The importance of time-dependent processes. Addiction. 1999;94(4):589-591.
  3. Lawental E. Ultra rapid opiate detoxification as compared to 30-day inpatient detoxification program -- a retrospective follow-up study. J Subst Abuse. 2000;11(2):173-181.
  4. O'Connor PG, Kosten TR. Rapid and ultrarapid opioid detoxification techniques. JAMA. 1998;279(3):229-234.
  5. Rosenberg H, Melville J, McLean PC. Acceptability and availability of pharmacological interventions for substance misuse by British NHS treatment services. Addiction. 2002;97(1):59-65.
  6. Badenoch J. A death following ultra-rapid opiate detoxification: The General Medical Council adjudicates on a commercialized detoxification. Addiction. 2002;97(5):475-477.
  7. American Society of Addiction Medicine. Public policy statement on opioid antagonist agent detoxification under sedation or anesthesia (OADUSA). J Addictive Dis. 2000;19:109-112.
  8. Gowing L, Ali R, White J. Opioid antagonists with minimal sedation for opioid withdrawal. Cochrane Database Syst Rev. 2009;(4):CD002021.
  9. Gowing L, Ali R, White J. Opioid antagonists under heavy sedation or anaesthesia for opioid withdrawal. Cochrane Database Syst Rev. 2010;(1):2022. 
  10. California Technology Assessment Forum (CTAF). Rapid and ultrarapid opiate detoxification. Technology Assessment. San Francisco, CA: CTAF; June 12, 2002. Available at: http://ctaf.org/ass/viewfull.ctaf?id=6048341319. Accessed April 20, 2005.
  11. Jhirwal OP, Basu D. Ultra-rapid opioid detoxification procedures in India: How far they are ethical? Indian J Med Sci. 2004;58(3):132-133.
  12. Camarasa X, Khazaal Y, Besson J, Zullino DF. Naltrexone-assisted rapid methadone discontinuation: A pilot study. Eur Addict Res. 2007;13(1):20-24.
  13. Naderi-Heiden A, Naderi A, Naderi MM, et al. Ultra-rapid opiate detoxification followed by nine months of naltrexone maintenance therapy in Iran. Pharmacopsychiatry. 2010;43(4):130-137.
  14. National Collaborating Centre for Mental Health. Drug misuse: Opioid detoxification. National Clinical Guideline 52. London, UK: National Institute for Health and Clinical Excellence (NICE); July 2007.
  15. Sigmon SC, Bisaga A, Nunes EV, et al. Opioid detoxification and naltrexone induction strategies: Recommendations for clinical practice. Am J Drug Alcohol Abuse. 2012;38(3):187-199.
  16. Weaver MF, Hopper JA. Opioid detoxification during treatment for addiction. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed February 2013.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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