Methods for acute and long-term treatment of drug addiction

Inactive Publication Date: 2015-08-20
DEMERX
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The invention is about a new treatment for opioid addiction that uses a narrow range of dosages of noribogaine. The treatment helps reduce withdrawal symptoms and increases the time it takes for the patient to resume using opioids. The optimal dosage range is between 1 mg / kg body weight and 4 mg / kg body weight, with a subrange of 1 mg per kg body weight to 3 mg per kg body weight. The patent also discusses the use of lower dosages of noribogaine to prevent reinduction of opioid use. The treatment involves administering a high therapeutic dose of noribogaine for a period of time to ameliorate withdrawal symptoms, followed by a decreasing maintenance dose to prevent relapse. The invention provides a safer treatment option with minimal risk of cardiotoxicity.

Problems solved by technology

While noribogaine has been disclosed for treatment of substance addiction, its use in humans is complicated by the fact that the ranges in the prior art are exceptionally broad (0.01 to 1000 mg / kg body weight).
Thus, the previously disclosed broad range has now been found to be insufficient for human therapy at the lower end of this range.
Moreover, the use of noribogaine imparts a dose dependent prolongation of the treated patient's QT interval, rendering higher dosing of noribogaine unacceptable.
A prolonged QT interval is a marker of potential ventricular tachyarrhythmia which, and can result in death.

Method used

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  • Methods for acute and long-term treatment of drug addiction
  • Methods for acute and long-term treatment of drug addiction
  • Methods for acute and long-term treatment of drug addiction

Examples

Experimental program
Comparison scheme
Effect test

example 1

Pharmacokinetics and Pharmacodynamics of Noribogaine in Humans

[0278]Thirty-six healthy, drug-free male volunteers, aged between 18-55 years, were enrolled in and completed the study. This was an ascending single-dose, placebo-controlled, randomized double blind, parallel group study. Mean (SD) age was 22.0 (3.3) years, mean (SD) height was 1.82 (0.08) m, and mean (SD) weight was 78.0 (9.2) kg. Twenty-six subjects were Caucasian, 3 were Asian, 1 Maori, 1 Pacific Islander, and 5 Other. The protocol for this study was approved by the Lower South Regional Ethics Committee (LRS / 12 / 06 / 015), and the study was registered with the Australian New Zealand Clinical Trial Registry (ACTRN12612000821897). All subjects provided signed informed consent prior to enrolment, and were assessed as suitable to participate based on review of medical history, physical examination, safety laboratory tests, vital signs and ECG.

[0279]Within each dose level, 6 participants were randomized to receive noribogaine...

example 2

Safety and Tolerability of Noribogaine in Humans

[0293]Safety and tolerability of noribogaine were tested in the group of volunteers from Example 1. Cold pressor testing was conducted in 1° C. water according to the method of Mitchell et al. (J Pain 5:233-237, 2004) pre-dose, 6, 24, 48, 72 and 216 hours post-dosing. Safety evaluations included clinical monitoring, recording of adverse events (AEs), safety laboratory tests, vital signs, ECG telemetry from −2 h to 6 h after dosing, and 12-lead electrocardiograms (ECGs) up to 216 hours post-dosing.

Results

[0294]A total of thirteen adverse events were reported by seven participants (Table 2). Six adverse events were reported by three participants in the placebo group, five adverse events were reported by two subjects in the 3 mg dose group, and one adverse event was reported by single subjects in the 10 mg and 30 mg dose groups, respectively. The most common adverse events were headache (four reports) and epistaxis (two reports). All adve...

example 3

Efficacy of Noribogaine in Humans

[0295]The efficacy of noribogaine in humans was evaluated in opioid-dependent participants in a randomized, placebo-controlled, double-blind trial. Patients had been receiving methadone treatment as the opioid substitution therapy, but were transferred to morphine treatment prior to noribogaine administration. This was done to avoid negative noribogaine-methadone interactions that are not observed between noribogaine and methadone. See U.S. Provisional Application No. 61 / 852,485, filed Mar. 15, 2013, which is incorporated herein by reference in its entirety.

[0296]In the first cohort, six patients were orally administered a single dose of 60 mg noribogaine, and three patients received placebo. In the second cohort, five patients were orally administered a single dose of 120 mg noribogaine, and three patients received placebo. Treatment was administered 2 hours after last morphine dose and the time to resumption of morphine (opioid substitution treatme...

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Abstract

This invention is directed to a method of treating opioid or opioid-like drug addiction, including acute and post-acute withdrawal symptoms, comprising treating an addicted patient with noribogaine at a dosage that provides an average serum concentration of 50 ng / mL to 180 ng / mL (AUC / 24 h) under conditions where the QT interval prolongation does not exceed about 50 milliseconds.

Description

FIELD OF THE INVENTION[0001]This invention is directed to a method of treating addiction to an opioid or opioid-like drug, including acute and post-acute withdrawal symptoms, comprising treating an opioid-addicted patient with noribogaine, noribogaine derivative, or pharmaceutically acceptable salt or solvate thereof at a dosage that provides a therapeutic serum concentration. In one embodiment, the average serum concentration is 50 ng / mL to 180 ng / mL (AUC / 24 h), including under conditions where the QT interval prolongation does not exceed about 50 milliseconds, and preferably about 30 milliseconds.STATE OF THE ART[0002]Substance addiction is a serious public health problem throughout the world. Heroin and other opioids, including prescription painkillers, are widely abused and account for a large percentage of illicit drug use. Opioid use is also linked to approximately 50% of violent crimes in the United States and costs the U.S. economy billions of dollars per year.[0003]Acute wi...

Claims

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Application Information

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IPC IPC(8): A61K31/55
CPCA61K31/55A61P25/04A61P25/30A61P25/36A61K31/407
Inventor FRIEDHOFF, LAWRENCE
Owner DEMERX
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