Nicotrol NS (Nicotine Nasal) - Summary

NICOTROL NS SUMMARY

Nicotrol^®NS
(nicotine nasal spray)
10 mg/mL

Nicotrol^® NS (nicotine nasal spray) is an aqueous solution of nicotine intended for administration as a metered spray to the nasal mucosa.

NICOTROL NS is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms. NICOTROL NS therapy should be used as a part of a comprehensive behavioral smoking cessation program.

The safety and efficacy of the continued use of NICOTROL NS for periods longer than 6 months have not been adequately studied and such use is not recommended.

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NEWS HIGHLIGHTS

Media Articles Related to Nicotrol NS (Nicotine Nasal)

Vitamin E Boosts Health Benefits Of Smoking Cessation
Source: Smoking / Quit Smoking News From Medical News Today [2013.04.25]
Taking a specific form of a vitamin E supplement can accelerate the health benefits that occur when people quit smoking, new research suggests. In the small study, improvement in blood vessel function associated with the added vitamin E potentially translates into an estimated 19 percent greater drop in future risk for cardiovascular disease...

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Published Studies Related to Nicotrol NS (Nicotine Nasal)

Nicotine nasal spray as an adjuvant analgesic for third molar surgery. [2011.05]
PURPOSE: To determine the efficacy of preoperatively administered nicotine nasal spray (3 mg) for analgesia after third molar (TM) surgery... CONCLUSION: Pain is well controlled by hydrocodone/acetaminophen in most patients after TM surgery. However, there is significant variability in pain reported. Nicotinic agonists represent a new class of analgesic that can be considered for patients who are expected to have significant opioid-resistant pain after TM surgery. Caution should be used with patients in whom a small increase in heart rate would be deleterious. Copyright (c) 2011 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Direction and magnitude of nicotine effects on the fMRI BOLD response are related to nicotine effects on behavioral performance. [2011.05]
Considerable variability across individuals has been reported in both the behavioral and fMRI blood oxygen level-dependent (BOLD) response to nicotine. We aimed to investigate (1) whether there is a heterogeneous effect of nicotine on behavioral and BOLD responses across participants and (2) if heterogeneous BOLD responses are associated with behavioral performance measures...

Treating heavy smokers in primary care with the nicotine nasal spray: randomized placebo-controlled trial. [2011.04]
AIMS: Of six established nicotine replacement therapy (NRT) formulations, only the gum and patch have been tested without specialist clinic support in placebo-controlled trials. We aimed to broaden the evidence base by examining if the nicotine nasal spray (NNS) could be effective with only brief support in general practice... CONCLUSIONS: NNS is effective when given in primary care. The benefit was lower than in a specialist clinic but similar to that with the nicotine patch in primary care. Unlike most other NRT formulations, bupropion or varenicline, NNS was especially helpful for more dependent smokers. Continuing treatment of those initially failing was not beneficial. An initial 1-week prescription to those more dependent on nicotine is likely to be the most cost-effective NNS treatment protocol. These results should offer support to the effectiveness of the other NRT formulations untested in this setting. (c) 2011 The Authors, Addiction (c) 2011 Society for the Study of Addiction.

Treating heavy smokers in primary care with the nicotine nasal spray: randomized placebo-controlled trial. [2011]
general practice... CONCLUSIONS: NNS is effective when given in primary care. The benefit was lower

Effects of nicotine patch or nasal spray on nicotine and cotinine concentrations in pregnant smokers. [2009.09]
OBJECTIVE: To examine the short-term effects of the nicotine patch or nasal spray on measures of nicotine exposure, withdrawal symptoms, and on maternal and fetal heart rates in pregnant smokers... CONCLUSIONS: Nicotine patch and nasal spray reduce maternal nicotine exposure compared with smoking and may be effective for smoking cessation.

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Clinical Trials Related to Nicotrol NS (Nicotine Nasal)

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.

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 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.

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