Comparisons of Nicotine-Free Cigarettes, Extra Low Nicotine Cigarettes vs. Medicinal Nicotine

2014-08-27 03:26:45 | BioPortfolio


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 4 mg nicotine lozenge. The tobacco toxin profiles across these various products will be compared. The effects of these products on biomarkers of exposure and risk factors for disease, compensatory smoking, components of tobacco addiction and short-term smoking cessation will be determined. Predictors of response to these products (e.g., compensatory smoking, compliance with product use, time to lapse) will also be examined.

The following primary hypothesis will be tested: 1) Extent of tobacco toxin exposure will be greatest for the extra low nicotine cigarette and least for nicotine lozenge. Other secondary hypotheses include: 2) Compensatory smoking, as calculated by using cotinine, will be greatest for the extra low cigarette compared to the nicotine-free cigarette; 3) Greater positive subjective responses to cigarettes will be observed with extra low nicotine vs. nicotine-free cigarette; 4) Similar withdrawal symptoms and negative affect will be observed with nicotine-free cigarette and nicotine lozenge, and least withdrawal and negative affect with the extra low nicotine cigarette; 6) Least dependence and greatest motivation and self-efficacy to quit will be observed with nicotine lozenge and the greatest dependence and least motivation and self-efficacy to quit with the extra low nicotine cigarette use; 7) Shorter time to lapse will be observed with extra low nicotine vs. nicotine-free cigarettes because of extinction is likely to occur with nicotine-free cigarettes, and the longest time to lapse for nicotine lozenge because the cigarette condition groups will have experienced stronger attentional bias toward cues, and more dependence prior to the quit date and greater withdrawal after the quit date.


Smokers (N=150) will be enrolled in the study and will smoke ad libitum for a period of two weeks during which time they will be assessed for baseline measurements. Subjects will then be randomly assigned to one of the three conditions (N=50). Subjects will be blinded as to whether they are assigned to the Quest nicotine-free vs. extra low nicotine condition. There are no distinguishing features between these two cigarettes. Nicotine lozenge assignment is open label. Subjects will be asked to use only their assigned study product (low nicotine, nicotine-free cigarettes or lozenge) for a period of 6 weeks. Study cigarettes will be given to them at each clinic visit and subjects will be told to smoke ad libitum. They will be provided a supply equivalent to 150% of their baseline-smoking rate to allow for compensatory smoking to occur. They will keep record of each cigarette they smoked. If they smoked cigarettes other than those assigned to them, they will be asked to notate on a sheet when that cigarette was smoked. At the end of the 6-week period, they will be asked to quit smoking and NRT.

First morning urine and fasting blood samples will be collected at baseline and 2 and 6 weeks on the study products; at 6 weeks of abstinence and the 1 month follow-up.

Counseling. In each condition, subjects will be provided brief, structured counseling that is similar in duration. The subjects in the cigarette conditions will discuss any difficulties they experienced with switching cigarettes and problem solving these obstacles. Problem solving each obstacle will be solicited from the subject. However, if no solution or limited solution is provided, the counselor will provide a standardized response for each of the obstacles confronted.

Follow-up Phase. Subjects will be followed up 1 month after the end of the 6 week abstinence period.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Tobacco Dependence


Nicotine free cigarettes, Extra-low nicotine cigarettes, Nicotine Lozenge


Univerisity of Minnesota
United States




National Institute on Drug Abuse (NIDA)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:26:45-0400

Clinical Trials [1059 Associated Clinical Trials listed on BioPortfolio]

Innovative Interventions for Smoking Cessation

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 cigaret...

The Role of Nicotine Dose and Route of Delivery in Affecting Adoption of E-cigarettes and Reducing Exposure to Toxic Combustion Products

This study plans to investigate whether using electronic cigarettes (e-cigarettes) or skin patches containing nicotine affects switching from smoking conventional combustible (burning) cig...

Effectiveness of Using Reduced Nicotine Cigarettes in Men and Women Smokers to Combat Nicotine Addiction

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...

Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace

This project will examine the impact of very low nicotine content (VLNC) cigarettes in a complex tobacco and nicotine product marketplace. We will compare the number of cigarettes smoked, ...

Effects of Nicotine Reduction on Smoking Behavior in ADHD Smokers

The purpose of this study is to investigate the impact of different nicotine levels in cigarettes with individuals who have ADHD.

PubMed Articles [6167 Associated PubMed Articles listed on BioPortfolio]

Free Radical, Carbonyl, and Nicotine Levels Produced by Juul Electronic Cigarettes.

Free radicals and carbonyls produced by electronic cigarettes (e-cigs) have the potential to inflict oxidative stress. Recently, Juul e-cigs have risen drastically in popularity; however, there is no ...

"Electronic Cigarettes" are not Cigarettes, and why that Matters.

With research about electronic cigarettes (e-cigarettes) rapidly increasing, this commentary addresses the conceptualization of e-cigarettes as similar to traditional cigarettes. The more we attempt t...

The relationship between cigarettes and electronic cigarettes: Evidence from household panel data.

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...

The association between perceived e-cigarette and nicotine addictiveness, information-seeking, and e-cigarette trial among U.S. adults.

Perceptions of harm and addictiveness are associated with smoking combusted cigarettes, but these factors have not been fully explored for e-cigarettes. Specifically, little is known about the perceiv...

Harm perceptions of electronic cigarettes and nicotine: A nationally representative cross-sectional survey of young people in Great Britain.

E-cigarettes often contain nicotine without the most harmful constituents of tobacco smoke.

Medical and Biotech [MESH] Definitions

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.

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.

Chewing gum which contains NICOTINE.


A plant genus of the family SOLANACEAE. Members contain NICOTINE and other biologically active chemicals; its dried leaves are used for SMOKING.

More From BioPortfolio on "Comparisons of Nicotine-Free Cigarettes, Extra Low Nicotine Cigarettes vs. Medicinal Nicotine"

Quick Search


Relevant Topics

Public Health
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...

Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...

Searches Linking to this Trial