Methods and compositions for reducing or eliminating symptoms of withdrawal from drugs and alcohol
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Abstract
Methods and compositions of reducing or eliminating the symptoms of withdrawal from drug or alcohol in drug or alcohol-dependent persons, while restoring the patient to nutritional health.The methods including parenteral administration of solutions containing high doses of ascorbic acid, including the serial administration of doses of ascorbic acid that differ in concentration by at least 10 fold (by weight).Compositions of the invention comprise at least about 20% (w),or at least about 25% (w), or at least about 30% (w), or at least about 35% (w), or at least about 38% (w) of ascorbic acid and a local anesthetic.
Core Innovation
The invention provides a method for attenuating symptoms of withdrawal to drugs or alcohol in a patient by parenterally administering staged doses of ascorbic acid. The regimen includes a first dose of a solution comprising an antioxidant dose of ascorbic acid, followed by a dose of a hypertonic solution comprising a pro-oxidative dose of ascorbic acid, and then a second dose of a solution comprising an antioxidant dose of ascorbic acid, with the first antioxidant dose being less than the second antioxidant dose.
The disclosed parenteral approach is contrasted with prior oral Vitamin C approaches that rely on inducing diarrhea, which is described as carrying concerns such as dehydration and gastrointestinal bleeding. Vitamin C is characterized as having antioxidant and pro-oxidant behavior, and the claimed effect is related to modulation of reactive oxygen species and free radicals.
The disclosure also describes mechanistic and patient-selection rationales connected to how dosing may interact with opioid and neuroreceptor sites and to factors that can influence safety, including screening such as G6PD go/no-go. In addition to ascorbic acid, some described compositions optionally include other substances such as a local anesthetic and nutrients, including B vitamins, minerals, amino acids, methylation agents, and glutathione, with the overall goal of attenuation of withdrawal symptoms and restoration of nutritional health.
Claims Coverage
The independent claim covers a parenteral, sequential three-step ascorbic-acid regimen that attenuates withdrawal symptoms by alternating antioxidant and pro-oxidative, hypertonic ascorbic-acid dosing. The coverage centers on the inventive ordering of steps a), b), and c), with quantitative constraints directed primarily to the hypertonic pro-oxidative step b).
Sequential antioxidant–pro-oxidative–antioxidant ascorbic-acid parenteral dosing
A method for attenuating symptoms of withdrawal to drugs or alcohol in a patient, comprising parenterally administering: a first dose of a solution comprising an antioxidant dose of ascorbic acid; then a dose of a hypertonic solution comprising a pro-oxidative dose of ascorbic acid; and then a second dose of a solution comprising an antioxidant dose of ascorbic acid, wherein step a) occurs before step b) and step b) occurs before step c), and wherein the first antioxidant dose of ascorbic acid solution is less than the second antioxidant dose of ascorbic acid solution.
Hypertonic pro-oxidative ascorbic-acid dose with concentration and administration-rate constraints
The pro-oxidative hypertonic step b) includes ascorbic acid at least 10 g in solution at a concentration greater than 0.2 grams/ml and at a rate greater than about 0.5 ml/minute.
Overall, the claim coverage is built around a staged parenteral regimen that attenuates withdrawal symptoms by administering an initial lower antioxidant ascorbic-acid dose, followed by a hypertonic pro-oxidative ascorbic-acid dose defined by concentration, mass, and administration-rate constraints, and then a higher antioxidant ascorbic-acid dose.
Stated Advantages
Attenuation of symptoms of withdrawal to drugs or alcohol in a patient.
Rapid removal of intoxicants/withdrawal symptoms within about 4–7 hours with minimal/no withdrawal symptoms.
Restoration of nutritional health.
Avoidance of oral Vitamin C-induced diarrhea and related concerns such as dehydration and gastrointestinal bleeding.
Documented Applications
Detoxification/attenuation of symptoms of withdrawal to drugs or alcohol, including an example for heroin withdrawal.
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