NICOTROL SUMMARY
Nicotrol® Inhaler
(nicotine inhalation system)
10 mg per cartridge
(4 mg delivered)
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 HIGHLIGHTSMedia Articles Related to Nicotrol (Nicotine Inhalation)
Smoking Cessation Program Offers Childhood Cancer Survivors Help To Quit The Habit
Source: Smoking / Quit Smoking News From Medical News Today [2009.11.17]
As smokers nationwide struggle to quit the habit, St. Jude Children's Research Hospital is offering assistance to those childhood cancer survivors who need help with smoking cessation. Despite the known health risks of tobacco use, about 18 percent of adults who survived childhood cancer are smokers-an average almost equal to that of the general population.
American Lung Association Urges Full Coverage Of Clinically Proven Smoking Cessation Treatments
Source: Respiratory / Asthma News From Medical News Today [2009.11.11]
As the debate over health care reform dominates the media and political arena, a new American Lung Association report finds that states aren't doing enough to help smokers quit - and policymakers must fix this in the health care reform process.
Medicaid Smoking Cessation Access on the Rise
Source: MedPage Today Psychiatry [2009.11.06]
Patients in 84% of the nation's Medicaid programs have access to tobacco-dependence treatment, but the availability and extent of coverage varied significantly, researchers found.
Published Studies Related to Nicotrol (Nicotine Inhalation)
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.
Effects of smoking cessation, acute re-exposure and nicotine replacement in smokers on AIR inhaled insulin pharmacokinetics and glucodynamics. [2008.04]
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: * Only one other study (Becker et al.) has reported on the influence of smoking cessation and smoking resumption on inhaled insulin pharmacokinetics and glucodynamics, concluding that the rapid changes associated with smoking resumption carry the risk for hypoglycaemia and thus should not be used by active smokers. WHAT THIS STUDY ADDS: * This is the first euglycaemic clamp study on the impact of smoking cessation, acute smoking re-exposure and nicotine replacement on AIR((R)) inhaled insulin pharmacokinetics and glucodynamics. * We demonstrate clinically and statistically significant shifts in glucodynamic response to acute re-exposure to a single cigarette, leading us to conclude that active smokers should be advised against inhaled insulin therapy until smoking abstinence is stable. * Additionally, these results are also the first to demonstrate an apparent independent effect of nicotine replacement therapy on insulin exposure and glucodynamic response. AIMS: To explore the effects of smoking cessation and acute smoking re-exposure on the pharmacokinetic (PK) and glucodynamic (GD) profiles of AIR inhaled insulin (AIR Insulin) with or without nicotine replacement therapy (NRT)... CONCLUSION: Smoking, smoking cessation and acute re-exposure with a single cigarette are associated with clinically significant alterations in AIR Insulin pharmacokinetics and glucodynamics. AIR Insulin should not be used by smokers or those at risk for recidivism.
Dose-related enhancement of mood and cognition in smokers administered nicotine nasal spray. [2008.02]
The discovery of the role of nicotinic receptors in attention and memory has led to the testing of nicotinic analogs as cognitive enhancing agents in patient populations...
Gender differences in affective response to acute nicotine administration and deprivation. [2007.03]
Men and women may differ in their sensitivity to the mood-modulating properties of nicotine. Male and female adult smokers were exposed to four sessions crossing two nicotine deprivation conditions (12-h deprived vs.The startle results suggest that both men and women are responsive to the hedonic properties of nicotine.
Randomized comparison of a nicotine inhaler and bupropion for smoking cessation and relapse prevention. [2007.02]
OBJECTIVE: To compare the combination of a nicotine inhaler and bupropion to either treatment alone for initiating smoking abstinence and relapse prevention... CONCLUSION: Combined therapy with a nicotine inhaler and bupropion increased smoking abstinence rates. Continuation of the initial combination therapy does not appear to prevent relapse to smoking. Timing of re-treatment and alternative approaches to relapse prevention should be further examined.
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.
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
cessation; and
2. identify predictors of response to these alternate forms of nicotine replacement therapy
(NRT).
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.
Nicotine Treatment of Mild Cognitive Impairment (MCI) [Active, not recruiting]
The purpose of this 12-month study is to determine whether nicotine, administered in the form
of nicotine patches, can improve symptoms of memory loss in some people experiencing mild
memory problems (referred to in this study as "mild cognitive impairment" or MCI).
Transdermal Nicotine Patch to Reduce Nicotine Craving and Withdrawal in Schizophrenics [Active, not recruiting]
Individuals with schizophrenia are three times as likely to smoke cigarettes as individuals
without schizophrenia. While a great deal of research has been focused on smoking cessation
programs for healthy individuals, little attention has been directed towards developing an
effective smoking cessation treatment for schizophrenics. This study will evaluate the
effectiveness of a transdermal nicotine patch at reducing nicotine craving and withdrawal
symptoms in schizophrenic individuals who are heavy smokers.
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