Methods for nicotine replacement dosage determination

a nicotine replacement and dosage technology, applied in the field of smoking cessation assistance, can solve the problems of patient relapse, inability to accurately predict the nicotine replacement level of blood, and inability to adapt the nicotine transdermal replacement dosage to previous daily cigarette consumption

Inactive Publication Date: 2004-01-08
SACHS DAVID P L
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  • Summary
  • Abstract
  • Description
  • Claims
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AI Technical Summary

Benefits of technology

[0014] It is important to reach the target blood nicotine level, delivered by the therapeutic medication, as rapidly as possible after smoking cessation, referred to as the patient's Target Quit Date. If there is delay, and the blood nicotine level is too low, then risk of relapse back to smoking can increase 10-fold in the first day or two after Target Quit Date. Conversely, if the physician initiates treatment with too high a therapeutic nicotine medication dose, then the patient could experience untoward side effects, such as nausea or vomiting, causing the patient to stop medication and likely relapse back to smoking. The present invention allows the physician to start the patient with the proper dose of nicotine replacement medication which individually optimizes that patient's chance of successfully stopping smoking.

Problems solved by technology

(1989) publication reported that nicotine transdermal replacement dosages adapted to previous daily cigarette consumption was no more effective than a standard dosage for achieving successful smoking cessation therapy.
Surprisingly, however, it is also observed herein that nicotine replacement levels of blood cannot be adequately predicted based upon the level of administered dosage alone.
Conversely, if the physician initiates treatment with too high a therapeutic nicotine medication dose, then the patient could experience untoward side effects, such as nausea or vomiting, causing the patient to stop medication and likely relapse back to smoking.

Method used

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Materials and Methods

[0029] 1. Study Design

[0030] Subject characteristics. Subjects were smokers, aged 18 years or more, were eligible if they had smoked at least 10 cigarettes per day for a minimum of 3 years, were motivated to stop smoking completely, and were basically in good health. Exclusion criteria were severe or symptomatic cardiovascular disease, pregnancy or breast feeding, current regular use of psychotropic medications, current or past alcohol or other drug abuse, current use of smokeless tobacco, or chronic dermatological disorders such as psoriasis, urticaria, or chronic dermatitis.

[0031] Allocation to Treatment. Subjects were sequentially and randomly assigned to receive one of three treatments based on a target percent cotinine replacement (% Cot Repl): 0% (placebo), 50%, or 100% cotinine replacement. In addition, subject enrollment was stratified by sex and nicotine dependency according to Table 1. Ninety-one subjects were assigned into the matrix shown in Table 1 ...

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Abstract

A method for predicting nicotine replacement dosage to achieve a target nicotine serum concentration relies on measuring blood nicotine concentration prior to smoking cessation. At least two values corresponding to other patient characteristics, such as body mass, cumulative smoking, psychological dependence, age, and menopausal status, are also determined and used to predict expected blood nicotine concentrations based on nicotine replacement dosages. Such methods are useful in achieving target blood nicotine concentrations for smoking cessation and therapy.

Description

[0001] This application is a divisional of application Ser. No. 08 / 422,381 (Attorney Docket No. 013012-000210), filed Apr. 13, 1995, which was a continuation-in-part of application Ser. No. 08 / 074,764 (Attorney Docket No. 013012-000200US), filed on Jun. 10, 1993, (now abandoned), the disclosure of which is incorporated herein by reference.[0002] 1. Field of the Invention[0003] The present invention relates generally to methods for smoking cessation assistance, and more particularly to methods for determining and predicting dosages utilized in nicotine replacement therapy employed in conjunction with smoking cessation techniques.[0004] Cigarette smoking is a serious health concern in the United States and throughout the world, being a significant causative factor in several types of cancer, heart disease, and other disabilities. While the risk of these diseases can be greatly reduced by simply stopping smoking, tobacco dependency makes stopping very difficult for many patients. Thus,...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K49/00G01N33/94
CPCA61K49/0008G01N33/94Y10T436/17Y10S436/816Y10S436/901
Inventor SACHS, DAVID P.L.
Owner SACHS DAVID P L
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