Track topics on Twitter Track topics that are important to you
The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and nicotine-free cigarette compared to 21 mg nicotine patch only and nicotine-free cigarette only on abstinence and withdrawal symptoms. The study will determine if adding nicotine replacement medication to the nicotine-free cigarettes will augment treatment compared to nicotine patch only or to nicotine-free cigarettes only.
The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and nicotine-free cigarette compared to the nicotine-free cigarette alone or 21 mg nicotine patch alone on abstinence and withdrawal.
The following primary hypothesis will be tested:
-1)Abstinence rates will be highest and the time to relapse will be the longest in the nicotine-free cigarettes plus nicotine patch condition compared to nicotine patch or nicotine-free cigarettes alone.
Other hypotheses include:
- 1)Greater positive subjective responses to cigarettes will be observed with nicotine-free cigarettes plus patch vs. nicotine-free cigarette;
- 2)Less drop-outs will be observed in the nicotine-free plus patch vs the other two conditions;
- 3)Similar withdrawal symptoms and negative affect will be observed with nicotine-free cigarette condition and the nicotine patch alone condition, and least withdrawal and negative affect with the nicotine-free cigarette plus nicotine patch condition; and
- 4)Less compensatory smoking will be observed in the nicotine-free plus patch condition compared to nicotine-free cigarette alone condition.
Cigarette smokers will be randomized to:
1)denicotinized cigarettes (which provide sensory behavioral aspects of smoking but with no nicotine) plus nicotine patch for 6 weeks; -2)nicotine patch for 6 weeks; or - 3)denicotinized cigarettes alone.
Outcome measures will include cessation assessed at the end of treatment as the primary endpoint and at 12, 16, 24 and 36 weeks post-treatment, time to lapse and relapse to usual brand cigarettes, withdrawal symptoms and craving and biomarkers of toxicant exposure. Predictors of abstinence and treatment response for each of the treatment conditions will be explored.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Nicotine Patch, Nicotine Free Cigarettes, Nicotine Free Cigarette Plus Nicotine Patch
University of MN's Tobacco Use Research Center
National Institute on Drug Abuse (NIDA)
Published on BioPortfolio: 2014-08-27T03:16:34-0400
In this study, smokers will be randomly assigned to one of three conditions for six weeks: 1) nicotine-free cigarettes (0.05mg); 2) extra low nicotine cigarettes (0.3 mg); or 3) medicinal ...
This study plans to investigate whether using electronic cigarettes (e-cigarettes) or skin patches containing nicotine affects switching from smoking conventional combustible (burning) cig...
The purpose of this study is to assess the effects of electronic cigarettes-nicotine and electronic cigarette-nicotine free on endothelial function as compared to traditional cigarettes. ...
This is a 2-year study involving the progressive reduction in the nicotine content of cigarettes. The investigators believe that at the end of the study smokers of cigarettes with progress...
This is a pilot human experimental study to evaluate whether the use of an e-cigarette affects lung function, exhaled CO levels, and quantitative tobacco cigarette consumption in active to...
Nicotine harms adolescent brain development and contributes to addiction. Some adolescents report using nicotine-free e-cigarettes, but the accuracy of their reporting is unclear. We explored adolesce...
We use the Nielsen Consumer Panel to investigate the impact of tobacco control policies on purchases of electronic cigarettes (e-cigarettes), cigarettes, and smoking cessation products. We measure pro...
Confirming preclinical findings, nicotine in humans (via smoking) enhances reinforcement from non-drug rewards. Recent demonstration of similar effects with nicotine via e-cigarettes suggests they may...
Nicotine is a dangerous substance extracted from tobacco leaves. When nicotine is absorbed in excessive amounts, it can lead to respiratory failure and cardiac arrest. The commercialization of electro...
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 ciga...
Nicotine is highly toxic alkaloid. It is the prototypical agonist at nicotinic cholinergic receptors where it dramatically stimulates neurons and ultimately blocks synaptic transmission. Nicotine is also important medically because of its presence in tobacco smoke.
Electronic devices that are designed to provide NICOTINE in the form of an inhaled aerosol. They typically are made in the shape of CIGARETTES in order to simulate the experience of CIGARETTE SMOKING.
Chewing gum which contains NICOTINE.
SMOKING vapors produced from ELECTRONIC NICOTINE DELIVERY SYSTEMS.
A plant genus of the family SOLANACEAE. Members contain NICOTINE and other biologically active chemicals; its dried leaves are used for SMOKING.
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...