Opioid Treatment Paradigms

There are two accepted paradigms for opioid addiction; abstinence and replacement therapy. Replacement regimes typically substitute acute acting opioids such as Heroin, Morphine, Oxycodone, etc. with long acting drugs such as Methadone or Buprenorphine. Abstinence protocols require a complete detoxification from the drug as an initial step before psychological treatments can proceed. The detoxification process induces an abstinence syndrome commonly referred to as “withdrawal” and usually includes flu-like symptoms such as emesis (vomiting), diarrhea, hyperhidrosis (sweating heavily), as well as, other feelings of discomfort, including but not limited to hyperalgesia (sensitivity to pain) and negative mood changes. Natural detoxification can last several weeks or months and due to the subjective distress involved, 30-91% of participants may drop out (Singh and Basu, 2004). It should be noted that this sample, while significant, is of people who voluntarily entered the detoxification program. The failure rate among those forced into a program or unethically coerced by threat is far more disappointing and of great concern. Ultra-Rapid Opioid Detoxification (UROD) significantly compresses the time frame as well as the discomfort level experienced and since the subject is under anesthesia, the detoxification rate is 100% as they are unaware of the progress of the procedure and in any event, cannot escape.

Introduction

Western society is currently in the unenviable position of dealing with an old enemy that has returned with increased strength. While opioid abuse and subsequent addiction and dependence is not a new phenomenon, the current manifestation is unprecedented. Due to pharmaceutical refinement of natural opioids and the introduction of even more powerful synthetic opioids, there is great cause for concern. While it is difficult to assess illicit drug use statistics due to human beings being deceptive about illegal activity, there are two consequences of opioid abuse that cannot be hidden from the view of authorities; overdoses resulting in emergency room treatment and unfortunately, death. Death cannot hide behind the cloak of deception.

According to the Center for Disease Control and Prevention, more than 1,000 people are treated every day for opioid abuse (CDC, 2016). More concerning from this same report is that 33,000 people died from an opioid overdose in the US during the year 2015. The incidence of opioid overdose continues to rise at an alarming rate. At a House Intelligence Committee hearing on June 13, 2017, Attorney General Jeff Sessions testified under oath that in 2016 there were 52,000 opioid overdose deaths. Consider these statistics from the above CDC report:

“The majority of drug overdose deaths (more than six out of ten) involve an opioid. Since 1999, the number of overdose deaths involving opioids (including prescription opioids and heroin) quadrupled. From 2000 to 2015 more than half a million people died from drug overdoses. Ninety-one Americans die every day from an opioid overdose.

We now know that overdoses from prescription opioids are a driving factor in the 15-year increase in opioid overdose deaths. Since 1999, the amount of prescription opioids sold in the U.S. nearly quadrupled, yet there has not been an overall change in the amount of pain that Americans report. Deaths from prescription opioids—drugs like oxycodone, hydrocodone, and methadone—have more than quadrupled since 1999.” (CDC, 2016)

In light of this phenomenon which has been named a “crisis” and an “epidemic” by clinicians and governments alike, every intervention strategy should be considered seriously by governments as Public Safety is the primary responsibility of government and in this case Public Health has been demonstrably shown to be overlapping with Public Safety, not unlike other mortal threats of the past.

The Controversy

In order to assess the viability of UROD as an intervention strategy, there are two issues to sort out; efficacy and ethics. Does the research indicate that this procedure works? The short answer is yes. The detoxification process is complete. However, this is only the first step in the overall treatment of addiction. In order to justify the significant cost, as well as the risks associated not only with anesthesia, but the sudden detoxification process itself, can it be shown that it leads to long term abstinence compared to other interventions? As noted earlier, there are certain and specific risks to the patient as well as costs to society if this procedure is to be subsidized by taxpayer dollars. We will examine an overview of the procedure and issues that have arisen regarding both the efficacy of the procedure, as well as the ethical issues involved.

The Procedure

An accurate medical history is required to screen for contraindications. A full blood panel, as well as an EKG and lung X-ray to screen for irregularities are also requirements.

Medications to soften the withdrawal symptoms as well as an antiemetic are given pre-anesthesia. Anesthesia is induced using Propofol, a non-opioid drug that is short acting and easily titrated. This drug also has such an effect on memory that it has the nickname “milk of amnesia” which blunts the traumatic memories associated with surgery and is helpful with sudden withdrawal as well. Midazolam is added to the Propofol infusion to induce deeper sedation. Once sedated, a strong opioid antagonist called Naltrexone is slowly introduced and withdrawal signs are monitored along with vital signs associated with anesthesia. During the anesthesia, a naltrexone pellet can be inserted in the fat tissue of the lower abdomen (more about this later). When acute withdrawal signs subside, the patient is released from anesthesia and sedated with benzodiazepines for a suitable period. During the next 48 hours, careful monitoring is required and the patient is treated with medications to offset residual withdrawal systems and to remain sedated. Once stable, the patient can be released into the care of family or a home caregiver.

The Issues:

Efficacy

UROD has been shown to be both safe and effective as a means of detoxification when standard procedures are followed (Salimi A1, Safari F, Mohajerani SA, Hashemian M, Kolahi AA, Mottaghi K, 2014). Studies have shown that cardiac complications and gastrointestinal ulcerations have occurred but may be accounted for by deviating from standard anesthetic protocols and poor prescreening (EKG, etc.). However, it must be mentioned that some researchers analyzing data have found that there is no benefit to detoxification under sedation and the risks of anesthesia are high. This, combined with the costs and allocation of scarce resources are significant enough not to recommend the treatment ( Gowing L, Ali R, White JM, 2010). This is contradicted by the other studies cited. For example (Kaye, et al. 2003) suggests that traditional methods of detoxification such as weaning, even with substitution of Methadone is usually unsuccessful. The team also concludes that since the withdrawal process is extremely distressing, it deters people from attempting it. Others terminate the process and return to opioid use (Basu, 2004). Since this procedure is successful for these two groups of people, how can it be said that there are no benefits?

Ethics

Commercial practitioners have advertised this procedure as a “miracle cure” without true informed consent being sought. Obviously, the dangers, as well as the benefits need to be disclosed before obtaining consent and a full explanation of the residual symptoms in the days and weeks following the procedure given. Long term treatment should also be discussed. Detoxification is a first step.

There remains a public health debate regarding the allocation of scarce resources for this procedure which are properly the domain of government agencies. However, if the patient is willing to pay for services rendered, is it ethical for a government to outlaw a procedure that a patient may require for various reasons and agrees to assume the risks by giving consent after full disclosure?

Long Term Abstinence Success Rates

Detoxification is a distinct process from relapse prevention. (Diaper AM, Law FD, Melichar JK, 2014) The discontinuation of the drug is the goal of detoxification and using the tools mentioned, abstinence can be aided by pharmacological means.

The surgical insertion of the opioid antagonist Naltrexone blocks the opioid receptors and assists with the long term goal of abstinence (Singh and Basu, 2004). In a study of 424 patients taking oral Naltrexone over a two year period, 75.75% were successfully abstinent while all of those in the failure group had stopped taking Naltrexone (Salimi, et al., 2014). The subcutaneous pellet relieves the voluntary discontinuation during the critical period.

Conclusion

Ultra-Rapid Opioid Detoxification is both an effective and safe procedure for detoxification. The additional benefits of the insertion of a long term pellet helps maintain abstinence and is an aid to those in long term psychosocial addiction programs. The cost and expertise needed remain an issue for government but should not prevent others from having access to the procedure if they are willing to assume the risks and costs.

Peter MacNeil

References

Diaper AM, Law FD, Melichar JK. Pharmacological strategies for detoxification Br J Clin Pharmacol. 2014 Feb;77(2):302-14.

Kaye AD, Gevirtz C, Bosscher HA, Duke JB, Frost EA, Richards TA, Fields AM. Ultrarapid opiate detoxification: a review Can J Anaesth. 2003 Aug-Sep;50(7):663-71.

Gowing L1, Ali R, White JM. (2010) Opioid antagonists under heavy sedation or anaesthesia for opioid withdrawal Cochrane Database Syst Rev.

Salimi A, Safari F, Mohajerani SA, Hashemian M, Kolahi AA, Mottaghi K (2014) Long-term relapse of ultra-rapid opioid detoxification J Addict Dis.;33(1):33-40.

Singh J, Basu D. (2004) Ultra-rapid opioid detoxification: current status and controversies – Department of Psychiatry, Post Graduate Institute of Medical Education and Research, Chandigarh – 160012, India