Nicotrol (Nicotine Inhalation) - Summary

NICOTROL SUMMARY

NICOTROL^® Inhaler (nicotine inhalation system) consists of a mouthpiece and a plastic cartridge delivering 4 mg of nicotine from a porous plug containing 10 mg nicotine. The cartridge is inserted into the mouthpiece prior to use. Nicotine is a tertiary amine composed of a pyridine and a pyrrolidine ring. It is a colorless to pale yellow, freely water-soluble, strongly alkaline, oily, volatile, hygroscopic liquid obtained from the tobacco plant. Nicotine has a characteristic pungent odor and turns brown on exposure to air or light. Of its two stereoisomers, S(-)nicotine is the more active. It is the prevalent form in tobacco, and is the form in the NICOTROL Inhaler. The free alkaloid is absorbed rapidly through skin, mucous membranes, and the respiratory tract.

NICOTROL Inhaler is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms. NICOTROL Inhaler therapy is recommended for use as part of a comprehensive behavioral smoking cessation program.

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NEWS HIGHLIGHTS

Published Studies Related to Nicotrol (Nicotine Inhalation)

Acceptability and effectiveness for withdrawal symptom relief of a novel oral nicotine delivery device: a randomised crossover trial. [2011.07]
RATIONALE: Existing nicotine replacement therapies (NRT) improve the chances of smoking cessation but are limited by either relatively slow nicotine absorption rates or unpleasant side effects, leaving scope for the development of more effective and acceptable products. OBJECTIVES: This study aimed to test the acceptability and effectiveness for withdrawal symptom relief of a novel nicotine delivery device, the 'Nicotine Cannon' (NC), compared with three existing, equivalent products: the nicotine lozenge, mini-lozenge and nicotine inhalator... CONCLUSIONS: The 'Nicotine Cannon' is at least as effective as equivalent NRT in reducing withdrawal symptoms and more acceptable to users, suggesting that it would be a useful addition to existing NRT. The acceptability profile could make it particularly useful as a 'harm reduction' tool.

Silver acetate interactions with nicotine and non-nicotine smoke components. [2010.12]
Oral topical silver-containing formulations were marketed in the 1970s and 1980s as smoking deterrents, based on the finding that when using such formulations, an unpleasant taste occurs upon smoking. This approach has not been widely adopted, however, in part because of a lack of efficacy data... Further exploration is warranted of the use of silver-based preparations as a short-term adjunct to smoking cessation treatment.

Differential effects of nicotine on P50 amplitude, its gating, and their neural sources in low and high suppressors. [2010.10.27]
Sensory gating impairment in schizophrenia has been documented in the form of aberrant middle latency P50 event-related brain potential responses to S(1) and/or S(2) stimuli in a paired (S(1)-S(2)) auditory stimulus paradigm. Evidenced by a failure to suppress S(2) P50 or by attenuated S(1) P50s, these sensory deficits have been associated with increased smoking behaviour in this disorder, and may be related to the putative ameliorating effects of smoke-inhaled nicotine on neural mechanisms regulating gating...

Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial. [2010.04]
OBJECTIVES: To measure the short-term effects of an electronic nicotine delivery device ("e cigarette", ENDD) on desire to smoke, withdrawal symptoms, acceptability, pharmacokinetic properties and adverse effects... CONCLUSIONS: The 16 mg Ruyan V8 ENDD alleviated desire to smoke after overnight abstinence, was well tolerated and had a pharmacokinetic profile more like the Nicorette inhalator than a tobacco cigarette. Evaluation of the ENDD for longer-term safety, potential for long-term use and efficacy as a cessation aid is needed. Trial registration No.12607000587404, Australia and New Zealand Clinical Trials Register.

A randomized trial of nicotine replacement therapy in combination with reduced-nicotine cigarettes for smoking cessation. [2008.07]
A randomized double-blind, active controlled, parallel group, multi-center phase II clinical trial was conducted to evaluate the efficacy of reduced-nicotine cigarettes as a novel smoking cessation treatment (under Investigational Device Exemption 69,185)... Quest plus NRT offers promise as a new smoking cessation treatment.

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Clinical Trials Related to Nicotrol (Nicotine Inhalation)

Pilot Pharmacokinetic Study of Investigational Sublingual Nicotine Tablet Versus COMMIT Nicotine Lozenge [Completed]
The objective of this study is to compare the pharmacokinetics of an investigational 2 mg sublingual nicotine tablet (Pharmaceutical Productions Inc.) to a 2 mg Commit® nicotine lozenge (GlaxoSmith Kline) in a randomized crossover design in 6 male and female otherwise healthy smokers.

Neural Mechanisms Underlying Nicotine and Alcohol Combinations [Active, not recruiting]
Nicotine and alcohol are frequently used together and their combined use contributes to more than half a million deaths each year, with more alcoholics dying from smoking-related diseases than from alcohol-related diseases. Using a new multi-modal MRI approach combined with data fusion, the investigators propose to study how nicotine modulates alcohol-induced changes in the function of brain circuits. The investigators hypotheses are:

- functional connectivity (FC) in the reward network, containing components of the

mesolimbic dopamine system, will be altered by alcohol, and additional increases in FC will be observed if nicotine is also present (e. g., additive effects).

- co-administration of nicotine will counteract the effects of alcohol on FC in multiple

brain networks, including visual, sensorimotor and motor brain circuits, that may be associated with the impairing effects of alcohol

Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations [Completed]
The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the reference nicotine gums (2 mg and 4 mg) in healthy smokers.

Nicotine Vaccination and Nicotinic Receptor Occupancy [Completed]
This is a molecular imaging research study designed to examine how much nicotine gets into the brain before and after vaccination with NicVAX, a nicotine vaccine developed by Nabi Biopharmaceuticals. NicVAX (Nicotine Conjugate Vaccine) is an investigational vaccine designed as an aid to smoking cessation and long-term abstinence, as well as an aid to prevent relapses of a treated smoker. In this project we want to understand the degree to which NicVAX administration changes how much nicotine enters the brain in smokers.

Concurrent Bupropion / Varenicline for Smoking Cessation [Completed]
This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion. Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies. The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design

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Reports of Suspected Nicotrol (Nicotine Inhalation) Side Effects

Drug Ineffective (98),  Cough (33),  Dysgeusia (26),  Throat Irritation (26),  Dyspnoea (23),  Feeling Abnormal (22),  Malaise (21),  Tobacco User (20),  Anxiety (20),  Nausea (18), more >>