To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Personalized Dosing of Nicotine Replacement NRT to Effect 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. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Last Update Posted : June 14, See Contacts and Locations. Study Description. Medications for smoking cessation are currently only effective in helping a minority of smokers quit. Drug development is slow and expensive, so there is much interest in optimizing the effectiveness of existing treatments and medications.
Current standard doses of nicotine replacement therapy NRT are not effective for many smokers and in many cases provide less nicotine compared to when a smoker is smoking their usual number of cigarettes. The proposed study will test if a personalized dose of nicotine patch up to 84mg will improve quitting success in those who do not respond to a standard dose of NRT 21mg. Detailed Description:. FDA Resources. Arms and Interventions. Published Online: February 23, Author Contributions: Dr Schnoll had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Critical revision of the manuscript for important intellectual content: All authors. Conflict of Interest Disclosures: Drs Schnoll and Hitsman report receiving varenicline Chantix and placebo free of charge from Pfizer for use in ongoing National Institutes of Health—supported clinical trials.
No other disclosures were reported. Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy Continue. Figure 1. Clinical Trial Flow Diagram. View Large Download.
ITT indicates intention to treat. Figure 2. Table 1. Participant Characteristics. Table 2. Table 3. Trial Protocol. PubMed Google Scholar Crossref. Use of smoking-cessation treatments in the United States. Am J Prev Med. Treating Tobacco Use and Dependence: Update. Nicotine replacement therapy for smoking cessation.
Cochrane Database Syst Rev. PubMed Google Scholar. Clinical strategies to enhance the efficacy of nicotine replacement therapy for smoking cessation: a review of the literature.
Effectiveness of extended-duration transdermal nicotine therapy: a randomized trial. Ann Intern Med. Nicotine Tob Res. Chronic disease management for tobacco dependence: a randomized, controlled trial. Arch Intern Med. Extended treatment of older cigarette smokers.
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. J Clin Psychiatry. Br J Addict. Nicotine metabolic rate predicts successful smoking cessation with transdermal nicotine: a validation study.
Pharmacol Biochem Behav. Reliability and validity of a smoking timeline follow-back interview. Psychol Addict Behav. Google Scholar Crossref. The association between changes in alternative reinforcers and short-term smoking cessation. Drug Alcohol Depend. Biochemical verification of tobacco use and cessation. Measures of abstinence in clinical trials: issues and recommendations. The blind spot in the nicotine replacement therapy literature: assessment of the double-blind in clinical trials.
Addict Behav. Can the blind see? J Subst Abuse Treat. Relationship between adherence to daily nicotine patch use and treatment efficacy: secondary analysis of a week randomized, double-blind, placebo-controlled clinical trial simulating over-the-counter use in adult smokers.
Clin Ther. Save Preferences. Privacy Policy Terms of Use. This Issue. Views 10, Citations View Metrics. Twitter Facebook More LinkedIn. Original Investigation.
April Robert A. Schnoll, PhD 1 ; Patricia M. Study Design. Statistical Analysis. Sample Characteristics. Abstinence Rates. Secondary Outcomes. However, recent experience shows that most volunteers are usually more motivated to quit than to reduce smoking, unless the recruitment procedure is specifically adapted to enroll "reducers". Concurrent use of NRT and smoking is safe, as confirmed in the present study, and generally does not increase blood nicotine levels, particularly with nicotine gum or inhaler [ 12 ].
Nor are other biomarkers increased during smoking reduction while using nicotine inhaler [ 13 ]. The reduction in expired CO in reducers was highly significant, even at 12 months, which confirmed the efficacy of smoking reduction in our subjects. Current smoking cessation interventions are aimed at smokers who are already motivated and preparing to quit. A broader range of interventions is needed in order to bring more smokers into treatment and increase the numbers who are motivated to make quit attempts.
In addition to abrupt cessation, treatment guidelines should recommend NRT-assisted reduction, as a substantial body of evidence shows that gradually cutting down smoking can increase subsequent smoking cessation among smokers not currently interested in quitting [ 4 — 8 , 14 , 15 ].
In conclusion, NRT nicotine gum or inhaler doubled the quit rate compared to placebo and was safe. Active NRT achieved sustained abstinence rates of Cochrane Database of Systematic Reviews. Article PubMed Google Scholar. Tob Control. Wennike P, Danielsson T, Landfeldt B, Westin A, Tonnesen P: Smoking reduction promotes smoking cessation: results from a double blind, randomized, placebo-controlled trial of nicotine gum with 2-year follow-up.
Clin Pharmacol Ther. Nicotine Tob Res. Br J Addiction. Psychopharmacology Berl. Am J Health Behav. Article Google Scholar.
A pilot study using a nicotine inhaler. J Clin Psychopharmacol. Download references. We thank Anne Hendrie, freelance medical writer, for her valuable editorial work and comments on the manuscript. Amzer-Glas, rue de Brest, , Rennes, France. You can also search for this author in PubMed Google Scholar. Correspondence to Eva Kralikova. McNeil AB manufactures a range of nicotine replacement products, including nicotine gum and nicotine inhaler.
Jacques Le Houezec is a consultant in tobacco dependence for both the pharmaceutical industry and the public sector. TR performed the statistical analysis and participated in the writing of the manuscript. All authors read and approved the final manuscript. This article is published under license to BioMed Central Ltd. Reprints and Permissions. Kralikova, E. Smoking cessation or reduction with nicotine replacement therapy: a placebo-controlled double blind trial with nicotine gum and inhaler.
BMC Public Health 9, Download citation. Received : 26 May Accepted : 27 November Published : 27 November Anyone you share the following link with will be able to read this content:.
Sorry, a shareable link is not currently available for this article. Provided by the Springer Nature SharedIt content-sharing initiative. Skip to main content. Search all BMC articles Search. Download PDF. Abstract Background Even with effective smoking cessation medications, many smokers are unable to abruptly stop using tobacco. Results Significantly more smokers managed to quit in the Active group than in the Placebo group. Conclusion In conclusion, treatment with 10 mg nicotine inhaler or 4 mg nicotine chewing gum resulted in a significantly higher abstinence rate than placebo.
Background The efficacy of nicotine replacement therapy NRT as an aid to smoking cessation is well documented [ 1 ]. Figure 1. Study design and success definitions.
Full size image. Results Study population Out of the eligible subjects, smokers males, females , recruited between January and May entered the trial 11 enrolled subjects never attended baseline. Table 1 Demographic characteristics at baseline. Figure 2. Table 2 Primary efficacy results: smoking cessation and smoking reduction.
Full size table. Figure 3. Table 3 Plasma cotinine and expired carbon monoxide CO levels Full size table.
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