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.
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.
Clinical Trials Related to Nicotrol (Nicotine Inhalation)
Adjustment of DOses of NIcotine in Smoking Cessation (ADONIS) [Completed]
Nicotine replacement therapies (NRT) have proven efficacy to help smokers quit. However,
their effectiveness is low. This study aims to answer the question: Does the dose adjustment
of NRT according the saliva concentration of nicotine's main metabolite: cotinine improve
their efficacy compared with the lack of dose adjustment (usual care) in smoking patients
with smoking related disease condition.
A Pilot Drug Trial That Evaluates the Whitening Potential of Nicotine Gum [Completed]
The purpose of this research study is to evaluate the effects on existing tooth stain of
nicotine gum. The study will enroll adults who have visible tooth staining.
Assessment of High Dose Transdermal Nicotine for Fast Metabolizers of Nicotine [Recruiting]
Unfortunately, the investigators still need to assess and identify novel ways to help people
quit smoking. Differences between people in terms of how fast they metabolize nicotine
influences response to transdermal nicotine patches, the most popular nicotine dependence
treatment, and it affects plasma levels of nicotine from treatment. These studies suggest
that fast metabolizers of nicotine may show better quit rates if they receive higher doses
of transdermal nicotine. This preliminary study is designed to assess, for the first time,
whether fast nicotine metabolizers show higher quit rates if given high dose transdermal
nicotine, versus standard dose. The study findings may help to support a subsequent large
trial to assess standard versus high dose transdermal nicotine for slow versus fast
metabolizers of nicotine, which may lead to a more personalized approach to treating
nicotine dependence using the nicotine patch to improve therapeutic benefits of transdermal
Nicotine Vaccination and Nicotinic Receptor Occupancy [Recruiting]
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.
Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy (NRT) [Active, not recruiting]
The purpose of this research study is to:
1. compare the effectiveness of a nicotine patch and nicotine nasal spray for smoking
2. identify predictors of response to these alternate forms of nicotine replacement therapy
The ultimate objective is to obtain information necessary to match NRT to those smokers with
the greatest need and likelihood of benefit. The investigators hypothesize that the nicotine
nasal spray (NS) will result in significantly higher abstinence rates than transdermal
nicotine (TN) for the following subgroups of smokers: those with genotypes associated with
less transmission of dopamine or serotonin, or greater metabolism of nicotine; and those with
higher levels of novelty-seeking, depression, and attention deficit symptoms.
Reports of Suspected Nicotrol (Nicotine Inhalation) Side Effects
Drug Ineffective (98),
Throat Irritation (26),
Feeling Abnormal (22),
Tobacco User (20),
Nausea (18), more >>
Page last updated: 2011-12-09