Do We Really Need to Continue Pharmacotherapy for Opioid Use Disorder (OUD) Indefinitely?

Whitney²,

Fried

et al. 2016

Clin Med Rev Case Rep

Self Cite

In order to explore the initiation of detoxification of addictive patients to opiates/opioids (along with some other anti-withdrawal agents), we developed a protocol to be utilized in treatment centers particularly with heavily dependent opiate/opioid subjects. Out of 17 subjects, only three received Buprenorphine/Naloxone (Bup/nx) along with KB220Z. In this pilot, we first used a dose of KB220Z of 2 oz twice daily before meals along with clonidine and benzodiazepines and other anti-nausea and sleep aids including Gabapentin. The dose of KB220Z was maintained for 6 days in five individuals. In a second scenario, we utilized a higher dose of 4 oz every 6 hours, over a 6-day period. The higher dose was employed in another 12 patients. It is noteworthy that only 3 people have relapsed utilizing these two protocols during the first two weeks of the study, allowing for the remaining 82% to be maintained on KB220Z. The patients have been maintained without any additional Bup/nx for a minimum of 120 days and in one subject, 214 days. We are in the process of testing this hypothesis in multiple treatment centers across the United Sates utilizing data from the Clinical opiate Withdrawal Scale (COWS) pre and post KB220Z. We are in the process of testing this hypothesis in multiple treatment centers across the United Sates. While this does not constitute an acceptable controlled experiment, it does provide some preliminary evidence that agrees with an earlier study. Moreover, because of the utilization of standard detoxifying agents in this detoxification protocol, we cannot make any inference to KB220Z’s effects. However, out of 17 subjects, only three required Bup/nx suggesting an interesting finding. If further confirmed in larger studies, the utilization for opiate/opioid detoxification may provide a novel way to eliminate the need for addictive opioids during withdrawal and detoxification. This paradigm shift may translate to a reduction in utilizing powerful and addictive opioids like buprenorphine and methadone (especially in these patients at high genetic risk for addiction) as not only detoxifying agents, but also maintenance drugs. While extensive research is required, this pilot paves the way for future investigations that could assist in the reduction of addictive opiate/opioid use and mortalities amongst both the young and old in America.

Section: Discussionmentioning

confidence: 99%

Hypothesizing that a Pro-Dopaminergic Regulator (KB220z™ Liquid Variant) can Induce "Dopamine Homeostasis" and Provide Adjunctive Detoxification Benefits in Opiate/Opioid Dependence

Whitney²,

Fried

et al. 2016

Clin Med Rev Case Rep

Self Cite

“…To reiterate, Attention Deficit-Hyperactivity Disorder (ADHD) frequently continues into adulthood (Biederman, 1998). Recent neuroimaging studies found lowered baseline dopamine tone in the brains of affected individuals (Badgaiyan et al, 2015). Both genders, with or without comorbidities in ADHD, are at risk for Substance Use Disorder (SUD) and children treated with psychostimulants are not protected from long-term SUD (Biederman et al, 2007).…”

Section: Neuroimaging Studiesmentioning

confidence: 99%

“…Unfortunately, the only treatment available that has been approved by the FDA are “Medication Assisted Treatment” (MAT), which favors maintenance with even more powerful addictive drugs like Methadone and Buprenorphine/Naloxone (Nosyk et al, 2013). In addition, MAT-approved drugs for alcohol, opiates, and nicotine tend to reduce the function of brain dopamine, and most agencies do not recommend long-term use (Blum et al, 2011; Badgaiyan et al, 2015; Mitchell et al, 2016). …”

Section: Introductionmentioning

confidence: 99%

Hypothesizing That Neuropharmacological and Neuroimaging Studies of Glutaminergic-Dopaminergic Optimization Complex (KB220Z) Are Associated With “Dopamine Homeostasis” in Reward Deficiency Syndrome (RDS)

Febo

Fried³

et al. 2016

Substance Use & Misuse

Self Cite

Background There is need for better treatments of addictive behaviors, both substance and non-substance related, termed “Reward Deficiency Syndrome” (RDS). While the FDA has approved pharmaceuticals under the umbrella term Medication Assisted Treatment (MAT), these drugs are not optimal. Objectives It is our contention that these drugs work well in the short-term by blocking dopamine function leading to psychological extinction. However, use of buprenorphine/Naloxone over a long period of time results in unwanted addiction liability, reduced emotional affect, and mood changes including suicidal ideation. Methods We are thus proposing a paradigm shift in addiction treatment, with the long-term goal of achieving “Dopamine Homeostasis.” While this may be a laudable goal, it is very difficult to achieve. Nevertheless, this commentary briefly reviews past history of developing and subsequently, utilizing a glutaminergic-dopaminergic optimization complex [Kb220Z] shown to be beneficial in at least 20 human clinical trials and in a number of published and unpublished studies. Results It is our opinion that, while additional required studies could confirm these findings to date, the cited studies are indicative of achieving enhanced resting state functional connectivity, connectivity volume, and possibly, neuroplasticity. Conclusions/Importance We are proposing a Reward Deficiency Solution System (RDSS) that includes: Genetic Addiction Risk Score (GARS); Comprehensive Analysis of Reported Drugs (CARD); and a glutaminergic-dopaminergic optimization complex (Kb220Z). Continued investigation of this novel strategy may lead to a better-targeted approach in the long-term, causing dopamine regulation by balancing the glutaminergic-dopaminergic pathways. This may potentially change the landscape of treating all addictions leading us to the promised land.

“…Prescribing buprenorphine indefinitely, therefore, should not be an option, in our opinion.. Although not mainstream thinking, there is a view that long-term treatment with buprenorphine has no therapeutic advantage over short-term treatment, but has a number of disadvantages (Badgaiyan et al, 2015; Verdejo-García et al, 2013). …”

mentioning

confidence: 98%

“…Most authors have suggested that buprenorphine/naloxone should be utilized as a long-term opioid maintenance therapy based on the chronicity of opioid dependence (Gustin, Nichols, Martin, et al, 2015), while some others do not support this “mainstream” view (Badgaiyan, Sinha, Blum, 2015). …”

mentioning

confidence: 99%

Should the United States Government Repeal Restrictions on Buprenorphine/Naloxone Treatment?

Gold

Clark

et al. 2016

Substance Use & Misuse

Self Cite

Attention must be focused on needed changes to the current United States law that restricts physicians who prescribe buprenorphine for the detoxification or treatment of Opioid Use Disorder, to accepting no more than100 patients. The current system does not provide comprehensive treatment as defined by the American Society of Addiction Medicine (ASAM) criteria. Additionally, it suffers from both fragmentation and stigma and will require a significant change to comply with ASAM’s call for integrated delivery of comprehensive addiction treatment. This commentary calls for the development and implementation of “best practice,” by recommending caution in lifting the 100 patient limit until substantial achievement of this goal occurs. The authors call for an increase to 200 in the patient limit to be restricted to those physicians who are Board Certified in Addiction Medicine by the American Board of Addiction Medicine (ABAM) or in Addiction Psychiatry by the American Board of Psychiatry and Neurology (ABPN), or other responsible medical organizations. Any additional restriction lifting should follow a systemic evolution that rewards and documents competency. Such a system would involve the integration of treatment, treatment systems, and recovery with prescription medication. In addition, it should monitor emotional blunting, treatment progress and initiation of genetic addiction risk testing.