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Thursday, November 29, 2018

Scott Gottlieb: FDA FOIA #3: Bolliger Study

I found this study from 2000 in the latest FOIA response:  https://www.bmj.com/content/bmj/321/7257/329.full.pdf.  Hopefully this is not old news.

Study Objective: To determine whether use of an oral nicotine inhaler can result in long term reduction in smoking and whether concomitant use of nicotine replacement and smoking is safe.

The study describes something remarkable similar to vaping: "The active treatment comprised nicotine replacement through an inhalation device (Nicorette Inhaler, Pharmacia and Upjohn).12 13 The inhaler consists of a plastic mouthpiece into which a disposable cartridge containing 10 mg nicotine and 1 mg menthol is inserted. At room temperature the total available nicotine content is 4-5 mg per cartridge. The inhaler delivers about 13 ìg of nicotine per puff (average puff volume of 50 ml), which means that about 80 puffs are required to obtain 1 mg nicotine. [My description of the Nicorette Inhaler relative to vaping was published here.]"

The result: "In summary, our study shows that sustained, long term reduction in smoking with the nicotine inhaler can be achieved and maintained. Smoking reduction seems a feasible first step towards improved health and may ultimately lead to complete smoking cessation in people unable or unwilling to stop smoking abruptly."

Scott: I wonder why the FDA CTP would take this down off their web site?

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