Coverage Policy Manual
Policy #: 2003010
Category: Medicine
Initiated: June 2003
Last Review: December 2023
  Under Heavy Sedation or General Anesthesia as a Technique of Opioid Detoxification

Description:
The traditional treatment of opioid addiction involves substituting the opiate (i.e., heroin) with an equivalent dose of a longer acting opioid antagonist, i.e., methadone, followed by tapering to a maintenance dose. Methadone maintenance therapy does not resolve opioid addiction, but has been shown to result in improved general health, retention of patients in treatment, and a decrease in the risk of transmitting HIV or hepatitis. However, critics of methadone maintenance point out that this strategy substitutes one drug of dependence for the indefinite use of another.  Detoxification followed by abstinence is another treatment option, which can be used as the initial treatment of opioid addiction, or offered as a final treatment strategy for patients on methadone maintenance. Detoxification is associated with acute symptoms followed by a longer period of protracted symptoms (i.e., 6 months) of withdrawal. Although typically not life threatening, acute detoxification symptoms include irritability, anxiety, apprehension, muscular and abdominal pains, chills, nausea, diarrhea, yawning, lacrimation, sweating, sneezing, rhinorrhea, general weakness, and insomnia. Protracted withdrawal symptoms include a general feeling of reduced well being and drug craving. Relapse is common during this period.
 
Detoxification may be initiated with tapering doses of methadone or buprenorphine (an opioid agonist-antagonist), treatment with a combination of buprenorphine and naloxone (an opioid antagonist), or discontinuation of opioids and administration of oral clonidine and other medications to relieve acute symptoms. However, no matter what type of patient support and oral medications are offered, detoxification is associated with patient discomfort, and many patients may be unwilling to attempt detoxification. In addition, detoxification is only the first stage of treatment. Without ongoing medication and psychosocial support after detoxification, the probability is low that any detoxification procedure alone will result in lasting abstinence. Opioid antagonists, such as naltrexone, may also be used as maintenance therapy to reduce drug craving and thus reduce the risk of relapse.
 
Dissatisfaction with current approaches to detoxification has led to interest in using relatively high doses of opioid antagonists, such as naltrexone, naloxone, or nalmefene under deep sedation with benzodiazepine or general anesthesia. This strategy has been referred to as “ultra-rapid,”  “anesthesia assisted,” or “one-day” detoxification. The use of opioid antagonists accelerates the acute phase of detoxification, which can be completed within 24-48 hours. Since the patient is under anesthesia, the patient has no discomfort or memory of the symptoms of acute withdrawal. Various other drugs are also administered to control acute withdrawal symptoms, such as clonidine (to attenuate sympathetic and hemodynamic effects of withdrawal), ondansetron (to control nausea and vomiting), and somatostatin (to control diarrhea). Hospital admission is required if general anesthesia is used. If heavy sedation is used, the program can potentially be offered on an outpatient basis. Initial detoxification is then followed by ongoing support for the protracted symptoms of withdrawal. In addition, naltrexone may be continued to discourage relapse.
 
Ultra-rapid detoxification may be offered by specialized facilities. Neurad™ Treatment Centers, Nutmeg Intensive Rehabilitation, and Center for Research and Treatment of Addiction (CITA) are examples. These programs typically consist of three phases: a comprehensive evaluation, inpatient detoxification under anesthesia, and finally, mandatory post-detoxification care and follow-up. The program may be offered to patients addicted to opioid or narcotic drugs such as opium, heroin, methadone, morphine, Demerol, Dilaudid, fentanyl, oxycodone, hydrocodone, or butorphanol. Once acute detoxification is complete, the opioid antagonist naltrexone is often continued to decrease drug craving, thus hopefully reducing the incidence of relapse.

Policy/
Coverage:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Opioid antagonists under heavy sedation or anesthesia as a technique for opioid detoxification (i.e., ultra-rapid detoxification) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, opioid antagonists under heavy sedation or anesthesia as a technique for opioid detoxification (i.e., ultra-rapid detoxification) is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Rationale:
Background
Evaluation of the safety and effectiveness of ultra-rapid treatment of opioid withdrawal using sedation or general anesthesia involves consideration of a variety of outcomes. For example, one might consider the numbers of patients enrolling in detoxification programs. Many opioid addicts may be fearful of prolonged detoxification programs and thus may only seek treatment in an accelerated detoxification program. Advocates of ultra-rapid detoxification point out that an increasing enrollment in detoxification programs is and of itself an important outcome.  In addition, proponents suggest that the procedure is a rapid and painless method of detoxification. Therefore, an important outcome is the comparison of the duration and severity of withdrawal symptoms associated with ultra-rapid detoxification and other detoxification strategies.
 
The completion rate of a detoxification program is another possible outcome. As noted by Scherbaum, up to 30% of patients may drop out of traditional inpatient detoxification programs.  Using sedation or anesthesia, one is assured of 100% completion of detoxification. However, as is commonly pointed out, detoxification is only the first step in treating opiate addiction, and ultra-rapid detoxification programs may offer different types of long-term follow-up care, based on ongoing psychosocial support with or without additional medication, such as naltrexone. Therefore, the rate of abstinence during both the short-term 6-month period of protracted withdrawal symptoms and longer term abstinence are also important outcomes. For example, traditional methods of withdrawal (i.e., tapering doses of methadone or buprenorphine) require the patient to be in a therapeutic environment for a prolonged period of time, potentially reducing the risk of long-term relapse.
 
In addition, the success of any detoxification program must be evaluated according to the patient populations treated. For example, patients addicted to heroin may respond differently than those addicted to oxycodone, and response may vary according to duration of addiction, or prior attempts at traditional detoxification. Also, ultra-fast detoxification may be offered to patients on methadone maintenance, in a final effort to render these patients drug free. These patients may have been in a therapeutic environment for a prolonged period of time, and may have more stable personal lives than those attempting initial detoxification from heroin use. However, symptoms associated with methadone withdrawal are thought to be more severe than those associated with heroin or codeine withdrawal.
 
The major safety considerations regarding ultra-rapid detoxification are the risks associated with general anesthesia in combination with opioid antagonists. While patients are generally intubated and ventilated, eliminating the risk of choking, intravenous naloxone has been associated with cardiovascular complications such as cardiac arrest and pulmonary edema. These potential safety issues are particularly important, since opioid withdrawal itself is not associated with life threatening complications. In contrast, advocates of ultra-rapid detoxification point out that detoxification is a painful procedure, and that the risk of anesthesia has generally been considered acceptable when used to relieve pain.
 
Given the above considerations, assessment of ultra-rapid opioid detoxification will focus on data reporting the severity and duration of withdrawal symptoms and the short- and long-term outcomes of maintenance of abstinence in distinct populations of patients, based on type and duration of addiction. Efficacy outcomes will be balanced against the safety considerations of deep sedation or general anesthesia in conjunction with naloxone.
 
Reported Data
A search of the MEDLINE database did not identify any studies that directly compared the outcomes of ultra-rapid detoxification with other methods of detoxification. As also noted by two published reviews, the majority of the published literature consists of single institution case series including a variety of patient populations and a variety of protocols, varying in the opioid antagonist used, the dose and mode of administration, the anesthetic agent, duration of anesthesia, and adjunct medications used.  Two randomized studies were identified; however these studies focused on treatment regimens that varied only in the level of sedation used, and did not include a conventionally treated control group.
 
Regarding severity and duration of withdrawal symptoms, Gowing’s review suggests that most patients experienced moderate withdrawal symptoms lasting a few days post-anesthesia or sedation, including nausea, vomiting, diarrhea, and sleep disturbances.  In addition, withdrawal severity may also be related to the anesthetic used. However, without a controlled trial, no conclusion can be made regarding the duration or severity of withdrawal symptoms compared to other techniques of detoxification.
 
Most of the studies did not report short- or long-term follow-up of abstinence, and those studies that did include follow-up have reported conflicting results. For example, Seoane and colleagues reported that 279 of the 300 patients treated were abstinent after 1 month,  while in Cucchia’s study of 20 patients, 16 reported some resumption of heroin in the 6 months following detoxification, with 60% considered to have relapsed.  Albanese assessed relapse at 6 months in 120 patients. Relapse data were available for 111 patients; 55% were relapse free.  Again, without controlled studies in similar populations of patients, no conclusions can be drawn about the relative long-term efficacy of ultra-rapid detoxification compared with other treatment strategies.
 
A variety of adverse events have been reported in small numbers of patients, including vomiting while under anesthesia or sedation, various cardiac rhythmic disturbances, pulmonary dysfunction, and renal insufficiency.  Vomiting under sedation is particularly worrisome due to the threat of aspiration. Techniques reported to minimize this risk include intubation, use of prophylactic antibiotics, and the use of medication to diminish the volume of gastric secretions. Several deaths occurring either during anesthesia or immediately afterward have been reported.  Also, deaths subsequent to ultra-rapid detoxification have been reported.  Of particular concern is the fact that the use of opioid antagonists results in loss of tolerance to opioids, rendering the patients susceptible to overdose if the patient returns to his/her pre-detoxification dosage of illicit drugs.
 
In summary, the lack of controlled trials and the lack of a standardized approach to ultra-rapid detoxification does not permit scientific conclusions regarding the safety or efficacy of ultrarapid detoxification compared to other approaches that do not involve deep sedation or general anesthesia.
 
Other Information
In 2000, the American Society of Addiction Medicine published a public policy statement regarding opiate detoxification under sedation or anesthesia.  This policy statement enumerated a number of positions, with the following two most relevant to this discussion:
 
“Opioid antagonist agent detoxification under sedation or anesthesia (OAD USA) can be an appropriate withdrawal management intervention for selected patients, provided that such services are performed by adequately trained staff with access to appropriate emergency medical equipment.
 
Although there is medical literature describing various techniques of OAD USA, more research is needed to better define its role in opioid detoxification. Further studies of outcome are needed, including both the safety and efficacy of OAD USA as compared to other opioid detoxification modalities, as well as any differential effects on the long term rehabilitation of opioid addicts.”
 
2005 Update
A literature search was performed for the period of 2003 through November 2005. No additional published studies were identified that would prompt reconsideration of the policy statement. Therefore the policy is unchanged. Collins and colleagues reported on the results of a trial of 106 heroin addicts who were randomized to undergo detoxification with an anesthesia-assisted rapid opioid detoxification, buprenorphine-assisted rapid opioid detoxification, or clonidine-assisted opioid detoxification.  All patients received an additional 12 weeks of outpatient naltrexone maintenance. Mean withdrawal severities were similar among the 3 groups, and treatment retention in the 12-week follow-up period was also similar. However, the anesthesia procedure was associated with 3 potentially significant life-threatening adverse events. The authors concluded that the data did not support the use of general anesthesia for heroin detoxification.
 
2006 Update
A search of the MEDLINE database was performed for the period of September 2005 through September 2006. A randomized trial from a European center reported that the initial improvement in rate of opiate detoxification and abstinence (3 months) with anesthesia was not maintained with longer-term follow-up; both groups (36 patients treated with anesthesia and 34 with classical clonidine detoxification) showed less than 5% abstinence after 12 months.  In addition, a Cochrane review on heavy sedation or anesthesia for opioid withdrawal concluded that “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.”  Anesthesia for rapid opiate detoxification is considered to be investigational.
 
2007-2008 Update
A search of the MEDLINE database for the period of October 2006 through January 2008 did not identify any controlled trials. Therefore, the policy statement is unchanged.
 
2013 Update
A literature search conducted using the MEDLINE database through July 2013. There was no new information identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2010, a Cochrane review by Gowing and colleagues on opioid antagonists under heavy sedation or anesthesia for opioid withdrawal was published (Gowing, 2010). A total of 9 studies including 1,109 participants were eligible for inclusion; there were 8 randomized controlled trials (RCTs) and 1 non-randomized controlled trial. Four studies compared the intervention to conventional approaches of withdrawal, and 5 compared different regimens of antagonist-induced withdrawal. In 5 of the studies, all participants were withdrawing from heroin or other short-acting opioids; in 3 studies, they were using heroin and/or methadone and, in 1 study, all participants were withdrawing from methadone.
 
Due to differences in study designs (e.g., antagonist and anesthesia or sedation regimens, comparison interventions, outcome variables, etc.), few pooled analyses could be conducted. Findings from 3 trials (total n=240) comparing antagonist-induced and conventional withdrawal were pooled for several outcome variables. The number of participants completing maintenance treatment was significantly higher in the antagonist-induced group than in the conventional treatment group (relative risk [RR]: 4.28; 95% confidence interval [CI]: 2.91-6.30). The number of participants who continued maintenance treatment or were abstinent at 12 months also favored the antagonist-induced group (RR: 2.77; 95% CI: 1.37-5.61). Safety data from these 3 studies were not pooled. One of the studies reported no adverse effects, and 1 only reported adverse effects in patients who received octreotide during the anesthetic procedure; 7 out of these 11 patients (64%) experienced vomiting and/or diarrhea. The third study reported 3 serious adverse events, all of which occurred in the anesthesia group. There were no pooled analyses of the results of studies that evaluated the efficacy of differing opioid antagonist withdrawal regimens. One meta-analysis of safety data from 2 studies (total n=572) found a statistically significantly higher rate of adverse events with heavy sedation compared to light sedation (RR: 3.21; 95% CI: 1.13-9.12). Other adverse events included high rates of vomiting in several studies and, in 1 study, episodes of irregularities in respiratory patterns during withdrawal.
 
The authors of the Cochrane review commented that, due to variability among the trials, “it is not possible to identify ‘standard’ treatment regimens for antagonist-induced withdrawal in conjunction with heavy sedation or anesthesia.” They concluded that “the increased risk of clinically significant adverse events associated with withdrawal under heavy sedation or anesthesia make the value of anesthesia-assisted antagonist-induced withdrawal questionable.”
 
Several of the trials are described in more detail below:
 
Collins and colleagues reported on the results of a trial of 106 heroin addicts who were randomly assigned to undergo detoxification with an anesthesia-assisted rapid opioid detoxification, buprenorphine-assisted rapid opioid detoxification, or clonidine-assisted opioid detoxification (Collins, 2005). All patients received an additional 12 weeks of outpatient naltrexone maintenance. Mean withdrawal severities were similar among the 3 groups, and treatment retention in the 12-week follow-up period was also similar. However, the anesthesia procedure was associated with 3 potentially significant life-threatening adverse events. The authors concluded that the data did not support the use of general anesthesia for heroin detoxification.
 
Favrat and colleagues published an RCT from a European center in 2006. The trial reported that the initial improvement in rate of opiate detoxification and abstinence (3 months) with anesthesia was not maintained with longer-term follow-up; both groups (36 patients treated with anesthesia and 34 with classical clonidine detoxification) showed less than 5% abstinence after 12 months (Favrat, 2006).
 
Among the published RCTs are several that focused on treatment regimens that varied only in the level or type of sedation used and did not include a control group of patients that did receive rapid detoxification (Kienbaum, 2000; Seoane, 1997; Nasr, 2011). In 2011, Nasr and colleagues in Egypt compared ultra-rapid detoxification under general anesthesia with and without dexmedetomidine (Nasr, 2011). Another study, by Seoane and colleagues, compared rapid intravenous detoxification treatment under either monitored light intravenous sedation or unmonitored deep intravenous sedation (Seoane, 1997). No conclusions can be drawn from these studies about the relative efficacy of rapid detoxification and standard methods.
 
Among the adverse events reported in the Cochrane review, vomiting under sedation is particularly worrisome due to the threat of aspiration. Techniques reported to minimize this risk include intubation, use of prophylactic antibiotics, and the use of medication to diminish the volume of gastric secretions. Several deaths occurring either during anesthesia or immediately thereafter have been reported (Beam, 1999; Dyer, 1998; Gold, 1999; Solomont, 1997).  Also, deaths subsequent to ultra-rapid detoxification have been reported (Brewer, 1998). Of particular concern is the fact that the use of opioid antagonists results in loss of tolerance to opioids, rendering patients susceptible to overdose if they return to pre-detoxification dosage of illicit drugs (ASAM, 2000).
 
2014 Update
A literature search conducted through November 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Relapse after ultrarapid detoxification was examined in a 2014 study by Salimi et al (Salimi, 2014). A total of 424 patients with self-reported opioid use entered a treatment program at a single institution in Iran. Treatment consisted of rapid detoxification under general anesthesia and naltrexone maintenance therapy. Four hundred of the 424 patients (94%) completed 2 years of follow-up. Among completers, 97 patients (24%) experienced at least 1 incident of relapse. Patients who relapsed had significantly lower rates of long-term compliance with naltrexone therapy, and all of the patients who relapsed had discontinued naltrexone use prior to relapse. Mild AEs were common and did not differentiate between patients with successful abstinence versus relapse. For example, 52% of those with treatment success and 56% who relapsed (p>0.05) experienced mild muscle pain in the first 3 months after withdrawal. This study was uncontrolled and does not provide data on the relative efficacy of detoxification methods.
  
2015 Update
A literature search conducted through October 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A follow up study was done by Forozesshfard and colleagues to evaluate relapse after Ultrarapid detoxification (Forozesshfard, 2014).  This was a prospective study done in Iran and included 64 patients undergoing the procedure with general anesthesia, followed by outpatient treatment using naltrexone oral therapy, and free-of-charge monthly psychiatric visits. Of the 64 patients undergoing treatment, 48 patients (75%) suffered relapse within the first month, with 12 patients returning to opioid abuse at 3 months, and the remaining 4 patients by 6 months. Four patients (6%) had life-threatening complications during the procedure, including pulmonary edema, pneumothorax, bradycardia, and refractory delirium with hypertension and cardiac arrhythmia. None of these patients had a fatal event.
 
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov on November 23, 2015 did not identify any ongoing or unpublished trials that would likely influence this review.
 
2017 Update
A literature search conducted through October 2017 did not reveal any new information that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
In another study, by Coscarelli and colleagues in Brazil, chart records of 54 patients (59 eyes) who had ICRS with the Ferrara ring were retrospectively reviewed ((Coscarelli, 2012).  Mean corrected distance visual acuity (CDVA) improved from 0.45 LogMAR preoperatively to 0.30 LogMAR postoperatively. Mean corneal topographic astigmatism decreased from 3.37 D preoperatively to 1.69 D postoperatively.
 
2018 Update
A literature search was conducted through November 2018.  There was no new information identified that would prompt a change in the coverage statement.  
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2021. No new literature was identified that would prompt a change in the coverage statement.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2023. No new literature was identified that would prompt a change in the coverage statement.

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American Society of Addiction Medicine. Public Policy Statement on Opioid Antagonist Agent Detoxification Under Sedation Or Anesthesia (OADUSA). J Addict Dis 2000; 19(4):109-12.

Bearn J, Gossop M, Strang J.(1999) Rapid opiate detoxification treatments. Drug Alcohol Rev 1999; 18: 75-81.

Bovill JG.(2000) Opioid detoxification under anesthesia. Eur J Anaesthesiol 2000; 17(11):657-61.

Brewer C, Laban M, Schmulian, et al.(1998) Rapid opiate detoxification and naltrexone induction under general anaesthesia and assisted ventilation: experience with 510 patients in four different centers. Psychiatr Belg 1998; 98:181-9.

Brewer C.(1998) Opiate detoxification under anesthesia. BMJ 1998; 316(7149):1983-4.

Collins ED, Kleber HD, Whittington RA et al.(2005) Anesthesia-assisted vs buprenorphine- or clonidine-assisted heroin detoxification and naltrexone induction: a randomized trial. JAMA 2005; 294(8):903-13.

Coscarelli S, Ferrara G, Alfonso JF, et al.(2012) Intrastromal corneal ring segment implantation to correct astigmatism after penetrating keratoplasty. J Cataract Refract Surg. Jun 2012;38(6):1006-1013. PMID 22624900

Cucchia AT, Monnat M, Spagnoli J, et al.(1998) Ultra-rapid opiate detoxification using deep sedation with oral midazolam: short and long-term results. Drug Alcohol Depend 1998; 52(3):243-50.

Dyer C.(1998) Addict died after rapid opiate detoxification. BMJ 1998; 316(7126):170.

Favrat B, Zimmermann G, Zullino D et al.(2006) Opioid antagonist detoxification under anaesthesia versus traditional clonidine detoxification combined with an additional week of psychosocial support: a randomised clinical trial. Drug Alcohol Depend 2006; 81(2):109-16.

Fernandez-Vega Cueto L, Lisa C, Poo-Lopez A, et al.(2016) Intrastromal corneal ring segment implantation in 409 paracentral keratoconic eyes. Cornea. Nov 2016;35(11):1421-1426. PMID 27490048

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Gooberman LL.(1998) Rapid opioid detoxification. JAMA 1998; 279(23):1871-2.

Gowing L, Ali R, White J.(2000) Opioid antagonists under heavy sedation or anaesthesia for opioid withdrawal. The Cochrane Library; Issue 2; 2000.

Gowing L, Ali R, White J.(2010) Opioid antagonists under heavy sedation or anaesthesia for opioid withdrawal. Cochrane Database Syst Rev 2010; (1):CD002022.

Heikal MA, Abdelshafy M, Soliman TT, et al.(2017) Refractive and visual outcomes after Keraring intrastromal corneal ring segment implantation for keratoconus assisted by femtosecond laser at 6 months follow-up. Clin Ophthalmol. 2017;11:81-86. PMID 28096650

Hensel M, Kox WJ.(2000) Safety, efficacy and long-term results of a modified version of rapid opiate detoxification under general anaesthesia: a prospective study in methadone, heroin, codeine and morphine addicts. Acta Anaesthesiol Scand 2000; 44(3):326-33.

Kienbaum P, Scherbaum N, Thurauf N, et al.(2000) Acute detoxification of opioid addicted patients with naloxone during propofol or methohexital anesthesia: a comparison of withdrawal symptoms, neuroendocrine, metabolic and cardiovascular patterns. Crit Care Med 2000;28(4):969-76.

Miraftab M, Hashemi H, Hafezi F, et al.(2016) Mid-term results of a single intrastromal corneal ring segment for mild to moderate progressive keratoconus. Cornea. Dec 14 2016. PMID 27984365

Nasr DA, Omran HA, Hakim SM et al.(2011) Ultra-rapid opiate detoxification using dexmedetomidine under general anesthesia. J Opioid Manag 2011; 7(5):337-44.

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Solomont JH.(1997) Opiate detoxification under anesthesia. JAMA 1997; 278(16):1318-9.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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