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

机译:假设多巴胺能调节剂(KB220z™液体变体)可以诱导多巴胺稳态并在阿片类药物/阿片类药物依赖性中提供辅助解毒作用

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摘要

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 (Bupx) 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 Bupx 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 Bupx 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.
机译:为了探讨成瘾患者对鸦片/阿片类药物(以及其他一些抗戒断药)的排毒的开始,我们开发了一种协议,可用于治疗中心,尤其是对鸦片/阿片类药物高度依赖的受试者。在17名受试者中,只有3名接受了丁丙诺啡/纳洛酮(Bup / nx)和KB220Z。在这个飞行员中,我们首先在饭前两次每天两次使用KB220Z的剂量,并与可乐定和苯二氮卓类药物以及包括加巴喷丁在内的其他抗恶心和助眠剂一起使用。五个人中,KB220Z的剂量维持6天。在第二种情况下,我们在6天的时间内每6小时使用了4盎司的更高剂量。另有12位患者使用了更高剂量的药物。值得注意的是,在研究的前两周中只有3人使用这两种方案复发,因此剩余的82%可以保留在KB220Z上。在没有任何额外Bup / nx的情况下,患者至少维持了120天,而一名受试者则保持了214天。我们正在使用来自KB220Z前后的临床鸦片戒断量表(COWS)的数据在美国多个治疗中心对该假设进行检验。我们正在美国各地的多个治疗中心对这一假设进行检验,尽管这并不构成可接受的对照实验,但确实提供了一些与早期研究相吻合的初步证据。此外,由于此排毒协议中使用了标准排毒剂,因此我们无法推断KB220Z的效果。但是,在17名受试者中,只有3名需要Bup / nx,这表明一个有趣的发现。如果在更大的研究中得到进一步证实,那么鸦片/阿片类药物解毒的应用可能会提供一种新颖的方法,从而消除戒断和解毒过程中对成瘾性阿片类药物的需求。这种范式的转变可能意味着减少使用强力和成瘾性的阿片类药物(如丁丙诺啡和美沙酮)(尤其是在这些具有成瘾的高遗传风险的患者中)不仅用作排毒剂,而且用作维持药物。尽管需要进行广泛的研究,但该试点为将来的研究铺平了道路,这可能有助于减少美国年轻人和老年人的成瘾性鸦片/阿片类药物使用和死亡率。

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