Nicotine nasal spray and vapor inhaler: abuse liability assessment

Abstract

Acute subjective and physiological effects were examined to provide information relevant to abuse liability of new nicotine delivery systems. Subjects (n = 12) were overnight-deprived smokers who received 0, 4, 8 and 16 active puffs from nicotine-containing cigarettes (0.1 mg per puff), 0, 1, 2 or 4 nasal sprays (0.5 mg nicotine per spray) and 0, 30, 60 and 120 vapor inhalations (estimated 0.013 mg nicotine per inhalation) in a within-subject single blinded design. While smokers clearly liked cigarette puffs, there was much less evidence of liking produced by either nasal spray or vapor inhaler; only modest elevations on a measure of good drug effects were observed. The novel delivery products engendered unpleasant effects of burning throat and nose, watery eyes, runny nose, coughing and sneezing that might be expected to limit abuse liability. Nicotine plasma level and heart rate increase was dose-related for cigarettes and nasal spray but not for vapor inhaler, indicating limited nicotine delivery with the latter device. Overall, results are consistent with the conclusion that the nicotine nasal spray and vapor inhaler are of substantially lower abuse liability than cigarettes in experienced cigarette smokers receiving initial exposure to these products.

Dose-Related Enhancement of Mood and Cognition in Smokers Administered Nicotine Nasal Spray

“…However, ratings of drug liking did not differ as a function of dose, condition, and sex, suggesting that men and women were not able to discern active drug from placebo. The uniformly low ratings of drug liking are consistent with the minimal abuse liability of nicotine nasal spray (Schuh et al, 1997).…”

Nicotine alters mucin rheological properties

“…Therefore, it is a reasonable concern that the exposure of nicotine to airway via such route may equally hinder proper mucin hydration and alter rheological properties. Similar undesirable effects are implicated in other NRT including nicotine nasal spray, vapor inhaler, and nebulizer (8,44). Safety assessment and monitoring the nonconventional adverse effects are very much needed for various NRT products.…”

Impact of Nicotine Replacement Therapy on Smoking Behavior

“…However, the downside of the nasal spray is that most smokers experience nasal and throat irritation that discourages repeated use of the product (31, 85,92). Thus, compliance with the nasal spray is typically lower than with other types of nicotine medications (78).…”

“…A number of other nicotine delivery products including nicotine aerosol inhalers, water, straws, wafers, and even lollipops have been patented and may soon find their way into the marketplace (36, 65). Tobacco manufacturers including Philip Morris, R.J. Reynolds, and Japan Tobacco hold patents for devices that could be used to deliver aerosolized nicotine into the lungs providing a potentially safer alternative to conventional cigarettes (36,44,78).…”

“…A number of other nicotine delivery products including nicotine aerosol inhalers, water, straws, wafers, and even lollipops have been patented and may soon find their way into the marketplace (36, 65). Tobacco manufacturers including Philip Morris, R.J. Reynolds, and Japan Tobacco hold patents for devices that could be used to deliver aerosolized nicotine into the lungs providing a potentially safer alternative to conventional cigarettes (36,44,78).Another approach to improving nicotine medications is to offer them in different dosage strengths. Studies show that there is a dose-dependent relationship between NRT formulations and quit rates, although side effects become more common as the nicotine dose is increased (25, 42).…”