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Nicotine Lozenge

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1. To Assess the Bioequivalence of the 4mg Prototype Mini Nicotine Lozenge to the Reference Product 4 mg Nicotine Polacrilex Mini Mint Lozenge (Nicorette) in Healthy Smokers Under Fasting Conditions

To Assess the Bioequivalence of the 4mg Prototype Mini Nicotine Lozenge to the Reference Product 4 mg Nicotine Polacrilex Mini Mint Lozenge (Nicorette) in Healthy Smokers Under Fasting Conditions To Assess the Bioequivalence of the 4mg Prototype Mini Nicotine Lozenge to the Reference Product (Nicorette) in Healthy Smokers - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study (...) Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. To Assess the Bioequivalence of the 4mg Prototype Mini Nicotine Lozenge to the Reference Product (Nicorette) in Healthy Smokers The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our

2018 Clinical Trials

2. Randomized Trial to Compare Smoking Cessation Rates of Snus, With and Without Smokeless Tobacco Health-Related Information, and a Nicotine Lozenge. (PubMed)

Randomized Trial to Compare Smoking Cessation Rates of Snus, With and Without Smokeless Tobacco Health-Related Information, and a Nicotine Lozenge. Nicotine replacement medications are moderately effective in increasing quit rates. However, some smokers reject such aids, suggesting the value of considering alternative options. Snus, a smokeless tobacco product with low nitrosamine content, could offer an alternative. This study compared smoking cessation rates for snus, with and without (...) information about reduced risk relative to smoking, with a nicotine lozenge (without relative risk information).A randomized, open-label, multicenter clinical trial was performed with 649 smokers, aged 21 to 65, who smoked at least 10 cigarettes per day for the past year and who were motivated to quit smoking. Participants were followed for up to 12 months and were provided no counseling or support. Smoking cessation was analyzed as continuous smoking abstinence (no smoking following quit date

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2019 Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco

3. Nicotine replacement therapy for smoking cessation: nicotine gum and nicotine lozenge

Nicotine replacement therapy for smoking cessation: nicotine gum and nicotine lozenge Nicotine replacement therapy for smoking cessation: nicotine gum and nicotine lozenge Nicotine replacement therapy for smoking cessation: nicotine gum and nicotine lozenge Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation Nicotine replacement therapy for smoking cessation (...) : nicotine gum and nicotine lozenge. Lansdale: HAYES, Inc.. Directory Publication. 2011 Authors' objectives Nicotine withdrawal symptoms are extremely prevalent among patients attempting to quit, and are often cited as the reason for relapse. Nicotine replacement therapy (NRT) is designed to facilitate smoking cessation by providing nicotine through alternative delivery methods, thereby reducing or eliminating withdrawal symptoms without the ill effects of tobacco smoke inhalation. NRT is available

2011 Health Technology Assessment (HTA) Database.

4. Nicotine Lozenges in the Relief of Behaviorally Provoked Craving. (PubMed)

Nicotine Lozenges in the Relief of Behaviorally Provoked Craving. Environmental cues may precipitate nicotine cravings in smokers. We present 2 studies exploring the efficacy of nicotine mini lozenges to reduce nicotine craving in smokers following behavioral provocation.Healthy smokers aged ≥18 years enrolled. In Study 1, participants were stratified by number of cigarettes smoked daily; Study 2 enrolled only heavy smokers. After an abstinence period, participants engaged in behavioral (...) provocation to induce nicotine craving before receiving a nicotine mini lozenge (Study 1: 1.5 mg or 4 mg; Study 2: 4 mg) or matching placebo. Craving was assessed using a 100-mm visual analogue scale, and safety was monitored.In Study 1, neither nicotine mini lozenge dose significantly reduced craving in smokers versus placebo. In Study 2, 4-mg nicotine mini lozenges significantly reduced craving scores 5 minutes post-treatment (least-square mean [LSM] change from baseline: -41.8; 95% confidence interval

2018 American journal of health behavior

5. Pharmacokinetic characterization of three novel 4-mg nicotine lozenges (PubMed)

Pharmacokinetic characterization of three novel 4-mg nicotine lozenges Nicotine replacement therapy (NRT) increases the probability of smoking cessation. This study was conducted to determine if three prototype 4-mg nicotine lozenges produced locally in India were bioequivalent to a globally marketed reference product, Nicorette® 4-mg nicotine lozenge.Healthy adult smokers (N = 39) were treated with three prototype 4-mg nicotine lozenges in comparison with a reference 4-mg lozenge (...) in this single-center, randomized, open-label, single-dose, 4-way crossover study. Pharmacokinetic sampling was obtained to test for bioequivalence using maximal plasma concentration (Cmax) and extent of absorption (AUC0-t). Secondarily, AUC;0-∞, time to maximal plasma concentration (tmax), half-life (T1/2), elimination rate constant (Kel), and safety of the prototype lozenges versus the reference lozenge were compared.Each prototype 4-mg nicotine lozenge was found to be bioequivalent to the reference 4-mg

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2018 International journal of clinical pharmacology and therapeutics

6. A Bioequivalence Study of Two Nicotine Lozenges in Fasting Conditions in Healthy Smokers

A Bioequivalence Study of Two Nicotine Lozenges in Fasting Conditions in Healthy Smokers A Bioequivalence Study of Two Nicotine Lozenges in Fasting Conditions in Healthy Smokers - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies (...) before adding more. A Bioequivalence Study of Two Nicotine Lozenges in Fasting Conditions in Healthy Smokers The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03541044 Recruitment Status : Recruiting First Posted : May 30

2018 Clinical Trials

7. Single-Dose Bioequivalence Study Comparing Two 4 mg Nicotine Lozenges

Single-Dose Bioequivalence Study Comparing Two 4 mg Nicotine Lozenges Single-Dose Bioequivalence Study Comparing Two 4 mg Nicotine Lozenges - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Single-Dose (...) Bioequivalence Study Comparing Two 4 mg Nicotine Lozenges The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT03432312 Recruitment Status : Completed First Posted : February 14, 2018 Last Update Posted : August 9, 2018 Sponsor: Fertin Pharma A/S Information provided by (Responsible Party): Fertin Pharma A/S Study

2018 Clinical Trials

8. Single-Dose Bioequivalence Study Comparing Two 2 mg Nicotine Lozenges

Single-Dose Bioequivalence Study Comparing Two 2 mg Nicotine Lozenges Single-Dose Bioequivalence Study Comparing Two 2 mg Nicotine Lozenges - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Single-Dose (...) Bioequivalence Study Comparing Two 2 mg Nicotine Lozenges The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT03432273 Recruitment Status : Completed First Posted : February 14, 2018 Last Update Posted : August 9, 2018 Sponsor: Fertin Pharma A/S Information provided by (Responsible Party): Fertin Pharma A/S Study

2018 Clinical Trials

9. Comparing NicoBloc to Nicotine Lozenges

Comparing NicoBloc to Nicotine Lozenges Comparing NicoBloc to Nicotine Lozenges - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Comparing NicoBloc to Nicotine Lozenges The safety and scientific validity (...) , University of Alabama at Birmingham Study Details Study Description Go to Brief Summary: To examine the feasibility, acceptability, and preliminary impact of using NicoBloc compared to nicotine lozenges Condition or disease Intervention/treatment Phase Smoking Cessation Nicotine Dependence Drug: NicoBloc Drug: Nicotine Lozenge Phase 2 Phase 3 Detailed Description: Smoking remains the leading cause of preventable death in the U.S. with approximately 18% of the population continuing to smoke. However

2018 Clinical Trials

10. Single‐Dose Bioequivalence of Two Mini Nicotine Lozenge Formulations (PubMed)

Single‐Dose Bioequivalence of Two Mini Nicotine Lozenge Formulations Diverse nicotine replacement therapy options may improve consumer usage. This study was conducted to establish the bioequivalence of a new cherry-flavored mini lozenge with that of a currently marketed mint-flavored mini lozenge. The rate (Cmax ) and extent (AUC0-t ) of plasma nicotine absorption were compared after administration of 2- and 4-mg doses of each lozenge in healthy adult smokers (n = 43). The bioequivalence

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2017 Clinical pharmacology in drug development

11. Oral Mucosal Effects In Adult Smokers Associated With Two Nicotine Lozenge Formulations

Oral Mucosal Effects In Adult Smokers Associated With Two Nicotine Lozenge Formulations Oral Mucosal Effects In Adult Smokers Associated With Two Nicotine Lozenge Formulations - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies (...) before adding more. Oral Mucosal Effects In Adult Smokers Associated With Two Nicotine Lozenge Formulations The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT03087786 Recruitment Status : Active, not recruiting First Posted : March 23, 2017 Last Update Posted : September 20, 2017 Sponsor: Niconovum USA

2017 Clinical Trials

12. Timing of Nicotine Lozenge Administration to Minimize Trigger Induced Craving and Withdrawal Symptoms (PubMed)

Timing of Nicotine Lozenge Administration to Minimize Trigger Induced Craving and Withdrawal Symptoms Smokers are often advised to use nicotine lozenge when craving or withdrawal symptoms occur. This may be too late to prevent lapses. This study assessed if nicotine lozenge use prior to a common smoking trigger can minimize trigger induced increases in craving and withdrawal symptoms.Eighty-four smokers completed two laboratory sessions in random order. At one session, nicotine lozenge (...) was given immediately after a stressor (to approximate current recommended use - i.e., after craving and withdrawal symptoms occur); at the other session subjects were randomized to receive nicotine lozenge at time points ranging from immediately to 30min prior to the stressor. Withdrawal symptoms and urge to smoke were measured using the Minnesota Nicotine Withdrawal Scale and the Questionnaire of Smoking Urges (QSU).Relative to receiving lozenge after the stressor, a smaller increase in pre-stressor

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2017 Addictive behaviors

13. Nicotine patch plus lozenge gives greatest increases in abstinence from smoking at 6 months compared with placebo; smaller effects seen with nicotine patch alone, bupropion or nicotine lozenges alone or combined. (PubMed)

Nicotine patch plus lozenge gives greatest increases in abstinence from smoking at 6 months compared with placebo; smaller effects seen with nicotine patch alone, bupropion or nicotine lozenges alone or combined. 20436150 2010 05 05 2017 01 23 1468-9618 13 2 2010 Apr Evidence-based nursing Evid Based Nurs Nicotine patch plus lozenge gives greatest increases in abstinence from smoking at 6 months compared with placebo; smaller effects seen with nicotine patch alone, bupropion or nicotine (...) lozenges alone or combined. 50-1 10.1136/ebn1047 Buchanan Lynne L University of Nebraska Medical Center College of Nursing, Omaha, NE 68198-5330, USA. lbuchanan@unmc.edu eng Comment Journal Article England Evid Based Nurs 9815947 1367-6539 Arch Gen Psychiatry. 2009 Nov;66(11):1253-62 19884613 2010 5 4 6 0 2010 5 4 6 0 2010 5 4 6 1 ppublish 20436150 13/2/50 10.1136/ebn1047

2010 Evidence-Based Nursing

14. Pharmacokinetics of Nicotine Sublingual Tablets Versus Nicorette Lozenge in Healthy Smokers

Pharmacokinetics of Nicotine Sublingual Tablets Versus Nicorette Lozenge in Healthy Smokers Pharmacokinetics of Nicotine Sublingual Tablets Versus Nicorette Lozenge in Healthy Smokers - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more (...) studies before adding more. Pharmacokinetics of Nicotine Sublingual Tablets Versus Nicorette Lozenge in Healthy Smokers The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02906995 Recruitment Status : Completed First Posted : September 20, 2016 Last Update Posted : December 4, 2017 Sponsor: Friends

2016 Clinical Trials

15. Nicotine Metabolite Ratio Is Associated With Lozenge Use But Not Quitting in Smokeless Tobacco Users. (PubMed)

Nicotine Metabolite Ratio Is Associated With Lozenge Use But Not Quitting in Smokeless Tobacco Users. The nicotine metabolite ratio (NMR) of 3'-hydroxycotinine to cotinine is a noninvasive marker of the rate of nicotine metabolism. Fast metabolism (ie, a high NMR) is associated with lower cigarette smoking abstinence rates using transdermal nicotine replacement. We evaluated whether the NMR can be used to predict self-reported nicotine lozenge use and tobacco abstinence among smokeless tobacco (...) users treated for tobacco dependence.This was a secondary analysis of data from one arm of a large trial. Participants received quitting support materials and 4-mg nicotine lozenges by mail plus three coaching phone calls. Saliva kits were mailed for collection of saliva samples, which were analyzed for cotinine and 3'-hydroxycotinine. Self-reported tobacco and lozenge use were assessed at 3 months. Analyses were performed using Spearman rank correlation and logistic regression.Of the 160 saliva

2016 Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco

16. Nicotine Lozenge

Nicotine Lozenge Nicotine Lozenge Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Nicotine Lozenge Nicotine Lozenge Aka: Nicotine (...) Lozenge From Related Chapters II. Precautions Pregnancy Category: D III. Preparations: Nicotine Lozenges Available over the counter in the United States Caution: Lozenges contain 25% more nicotine than the Heavy smokers: 4 mg Use of 25 s per day First within 30 minutes of awakening Moderate smokers: 2 mg Less than 25 s per day IV. Dosing Maximum: 20 lozenges daily Avoid food or drink 15 minutes before gum Avoid acidic foods and beverages 30 minutes prior to use Taper schedule Week 1-6: One lozenge

2018 FP Notebook

17. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. (PubMed)

resulted in higher quit rates than using 15 mg (16-hour) patches, although in the latter case the CI included one. There was no clear evidence of superiority for 42/44 mg over 21/22 mg (24-hour) patches. Using a fast-acting form of NRT, such as gum or lozenge, resulted in similar quit rates to nicotine patches. There is moderate-certainty evidence that using NRT prior to quitting may improve quit rates versus using it from quit date only; however, further research is needed to ensure the robustness (...) Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Nicotine replacement therapy (NRT) aims to replace nicotine from cigarettes to ease the transition from cigarette smoking to abstinence. It works by reducing the intensity of craving and withdrawal symptoms. Although there is clear evidence that NRT used after smoking cessation is effective, it is unclear whether higher doses, longer durations of treatment, or using NRT before cessation add

2019 Cochrane

18. Comparison of nicotine oral soluble film and nicotine lozenge on efficacy in relief of smoking cue-provoked acute craving after a single dose of treatment in low dependence smokers. (PubMed)

Comparison of nicotine oral soluble film and nicotine lozenge on efficacy in relief of smoking cue-provoked acute craving after a single dose of treatment in low dependence smokers. Pilot study results suggested that a new form of nicotine oral soluble film relieved smoking cue-provoked acute craving faster than nicotine lozenge or gum. The new nicotine film may provide smokers another choice to relieve acute craving.This study compared the efficacy of the 2.5 mg nicotine oral soluble film to 2 (...)  mg nicotine lozenge for acute relief of smoking cue-provoked craving.A randomized, open label, active comparator controlled, parallel group study was conducted with 322 smokers enrolled. After 4 h of abstinence from smoking, eligible subjects were exposed to smoking cues as provocation. Immediately after the post-provocation baseline craving assessment using a 0-100 mm visual analogue scale (VAS), subjects took a randomized single dose of either the 2.5 mg nicotine film or the 2 mg nicotine

2014 Psychopharmacology

19. Nicotine replacement therapy versus control for smoking cessation. (PubMed)

to 1.60, 56 trials, 22,581 participants) for nicotine gum; 1.64 (95% CI 1.53 to 1.75, 51 trials, 25,754 participants) for nicotine patch; 1.52 (95% CI 1.32 to 1.74, 8 trials, 4439 participants) for oral tablets/lozenges; 1.90 (95% CI 1.36 to 2.67, 4 trials, 976 participants) for nicotine inhalator; and 2.02 (95% CI 1.49 to 2.73, 4 trials, 887 participants) for nicotine nasal spray. The effects were largely independent of the definition of abstinence, the intensity of additional support provided (...) Nicotine replacement therapy versus control for smoking cessation. Nicotine replacement therapy (NRT) aims to temporarily replace much of the nicotine from cigarettes to reduce motivation to smoke and nicotine withdrawal symptoms, thus easing the transition from cigarette smoking to complete abstinence.To determine the effectiveness and safety of nicotine replacement therapy (NRT), including gum, transdermal patch, intranasal spray and inhaled and oral preparations, for achieving long-term

2018 Cochrane

20. The effect of acute exercise on cigarette cravings while using a nicotine lozenge. (PubMed)

The effect of acute exercise on cigarette cravings while using a nicotine lozenge. It is imperative that smoking cessation aids effectively alleviate cigarette craving and withdrawal symptoms because their intensity has shown to predict relapse. The nicotine lozenge and a single session of exercise have both been shown to provide relief from craving for smokers who have stopped smoking. These two efficacious monotherapies have distinct mechanic pathways, and applying them concurrently may (...) provide additive-craving relief benefit.This study aimed to examine whether an acute bout of moderate-intensity exercise provides additional craving relief to the nicotine replacement lozenge in recently quit smokers.Thirty smokers who had abstained from smoking for 15 h were randomized to either the experimental (exercise and lozenge, n = 15) or control (lozenge alone, n = 15) condition. Craving was assessed before (baseline), during (10 and 20 min), and after (10, 20, 30, and 40 min) treatment.A

2015 Psychopharmacology

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