Treatment Trials

34 Clinical Trials for Various Conditions

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COMPLETED
Effects of an Oral Nicotine Product in Smokeless Tobacco Users
Description

The purpose of this research study is to find out how three different nicotine pouches and participant's own brand of smokeless tobacco affect blood nicotine levels and how participants feel.

Conditions
UNKNOWN
Treating Smokeless Tobacco Use in Rural Veterans
Description

This is a pilot study designed in an effort to develop and improve access to effective treatments for tobacco use in rural Veterans using a tailored intervention approach. Specifically, we will evaluate a combined behavioral and pharmacological smokeless tobacco cessation which concomitantly addresses comorbid issues commonly experienced by rural tobacco users including elevated depressive symptoms, risky alcohol use, and concerns about weight gain. The objectives are to: 1. Evaluate the feasibility of an individually-tailored telephone intervention for rural smokeless tobacco users 2. Examine the impact of the intervention on treatment utilization, patient satisfaction, and smokeless tobacco cessation.

COMPLETED
Novel Determinants and Measures of Smokeless Tobacco Use: Study 2
Description

The research project will determine the level of nicotine in ST products that will lead to the greatest reduction in toxicant exposure

COMPLETED
Novel Determinants and Measures of Smokeless Tobacco Use: Study 1
Description

The extent of toxicity varies considerably across different brands of smokeless tobacco (ST) products and data suggest that greater toxicity may result in greater health risks. However, little is known about the actual extent of exposure to toxicants from current smokeless tobacco products and factors that might moderate the extent of this exposure. The goals of this project are to address the following questions: 1. What are the characteristics of the range of smokeless tobacco products in current use and how do these products impact user behavior; 2. What are novel and the best measures of smokeless tobacco use, behavior and exposure; and 3. What are some of the determinants of smokeless tobacco use.

COMPLETED
Highdose Nicotine Patch Therapy for Smokeless Tobacco Use
Description

Smokeless tobacco use ("chewing") is associated with negative health effects. To date, no medications have been shown to help chewers quit long-term. High dose nicotine patch therapy may improve the chances that chewers can quit for good. If found to be effective, chewers may use this treatment to help them quit and reduce their risk for negative health effects.

COMPLETED
Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users
Description

The purpose of this record is to test whether (a) participants who receive a Web-based smokeless tobacco cessation intervention will be more likely to be abstinent than participants who do not receive this intervention, and (b) whether participants who receive a telephone quitline intervention will be more likely to be abstinent than participants who are not in a quitline intervention.

COMPLETED
Bupropion SR for Treating Smokeless Tobacco Use
Description

To determine the efficacy and safety of bupropion SR for quitting tobacco in smokeless tobacco users.

COMPLETED
Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use
Description

Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has health risks associated with its use. While treatment programs that focus on stopping tobacco use may be effective, past research has shown that interventions that specifically focus on reducing tobacco use may be equally effective and may motivate individuals to eventually quit using tobacco. This study will compare the effectiveness of a ST reduction treatment program versus a usual tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.

COMPLETED
Nicotine Lozenge to Reduce Smokeless Tobacco Use
Description

Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has as many health risks associated with its use as cigarettes. While there are many treatment programs that focus on stopping tobacco use, there are no interventions that specifically focus on reducing tobacco use. This study will evaluate the effectiveness of nicotine lozenge at reducing tobacco use in ST users.

COMPLETED
Effectiveness of Using Tobacco Free Snuff in Reducing Negative Effects of Smokeless Tobacco Use
Description

Though spit tobacco is smokeless, it still affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. Long-term effects of smokeless tobacco (ST) include tooth abrasion, gum recession, mouth disease, loss of bone in the jaw, yellowing of teeth, and chronic bad breath. This study will assess the effectiveness of using tobacco free snuff in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.

COMPLETED
Using Smokeless Tobacco Products With Lower Nicotine Levels to Reduce Negative Effects of Smokeless Tobacco Use
Description

Though spit tobacco is smokeless, it still affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. This study will assess the effectiveness of limiting smokeless tobacco (ST) nicotine intake in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.

TERMINATED
Metabolism of Deuterated NNN in Smokeless Tobacco Users
Description

The purpose of this study is to better understand how people break down a tobacco specific cancer-causing toxin called N'-nitrosonornicotine (NNN) that is present in smokeless tobacco and cigarettes. Some people are able to get rid of this chemical as a harmless agent better than others. Through this research, the investigators hope to develop a better understanding of how people process potentially harmful chemicals and identify tobacco users who are in danger of developing cancer. Participants will complete questionnaires regarding their health and smoking history. The investigators will take blood samples, saliva samples, cheek cells and urine to measure exposure to toxins and harmful chemicals present in smokeless tobacco. Participants will be given smokeless tobacco study product and be asked to use only it for the entire time they are in the study. The study product contains deuterated NNN. Deuterated NNN is just like the NNN found in commercially available smokeless tobacco products, but is labeled with deuterium or heavy hydrogen atoms. Deuterium is non-toxic and safe. Using smokeless tobacco containing deuterium allows us to follow NNN as it is broken down in the body.

COMPLETED
A Pilot Study Evaluating Nicotine Lozenges and Self Help
Description

The investigators are hypothesizing that by offering both self-help materials and mailed nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users, as well as decrease tobacco withdrawal.

COMPLETED
An Internet-Based Smokeless Tobacco Cessation Program for Teens
Description

To compare the efficacy of a targeted, tailored, and highly interactive smokeless tobacco cessation website to a website with more static information that is similar to websites that can be found through a typical Internet search.

COMPLETED
Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction
Description

This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6 months. ST users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo.

UNKNOWN
Preventing Relapse Following Involuntary Smoking Abstinence
Description

The prevalence of tobacco use in the military is too high. This study is designed to take advantage of the 8.5 weeks of forced tobacco cessation during Basic Military Training and develop effective interventions to prevent tobacco relapse. Hypotheses or Research Questions: * Are there differences in the rate of relapse between three groups participating in a tobacco abstinence maintenance intervention? * Do the tobacco abstinence maintenance interventions delay relapse?

COMPLETED
Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation
Description

This research study will determine if using a combination of 4-mg nicotine lozenges, self-help materials, and/or telephone tobacco cessation counseling will help smokeless tobacco users stop using tobacco. The study will consist of three interventions: 1. The Lozenge Assisted Self-help intervention - lozenge nicotine replacement therapy, phone counseling, and self help materials 2. Assisted Self-Help intervention - self-help materials and phone counseling without lozenges 3. Lozenge Self Help intervention - self help materials and lozenge nicotine replacement therapy. Hypothesis: The Lozenge Assisted Self-help intervention will significantly increase both the prolonged and point prevalence for all tobacco and smokeless tobacco (ST) abstinence rates at 6 months among ST users who are interested in achieving tobacco abstinence, compared to those in the Assisted Self-Help intervention and the Lozenge Self Help intervention.

COMPLETED
Nicotine Pharmacokinetics and Subjective Effects of Oral Nicotine Products Relative to Smokeless Tobacco in Adult Users
Description

The purpose of this study was to obtain information on nicotine exposure following the use of five oral tobacco-derived nicotine (OTDN) products relative to subjects' own brand moist smokeless tobacco (OBMST) product in adult moist smokeless tobacco (MST) users, as well as to characterize subjective effects under controlled use conditions. Male and female adult MST users between the ages of 22 to 65 years were recruited. The total duration of participation for each subject was approximately 34 days including screening and a 6-day in-clinic study confinement period.

Conditions
COMPLETED
CSD190103: A Study to Assess Nicotine Pharmacokinetic Parameters After Use of Two Smokeless Tobacco Products
Description

The purpose of this study is to compare plasma nicotine uptake in adult snus consumers after using investigational snus products (A19010-W and B19010-F).

Conditions
COMPLETED
CSD190102: A Study to Assess Nicotine Pharmacokinetic Parameters After Use of Two Smokeless Tobacco Products
Description

The purpose of this study is to compare plasma nicotine uptake in adult snus consumers after using investigational snus products (A19010-R and B19010-O).

Conditions
COMPLETED
CSD190101: A Study to Assess Nicotine Pharmacokinetic Parameters After Use of Two Smokeless Tobacco Products
Description

The purpose of this study is to compare plasma nicotine uptake in adult snus consumers after using investigational snus products (A19010-F and B19010-F).

Conditions
COMPLETED
Effects of FDA Authorized Smokeless Tobacco Claims Among US Adults Who Smoke Cigarettes
Description

This study will be an online survey experiment conducted with adults who smoke cigarettes (ages 21+) to examine their reactions to modified risk advertising claims authorized by the Food \& Drug Administration (FDA) for two smokeless tobacco brands (General Snus and Copenhagen), which describe the lower risks of these products compared to cigarette smoking. The study will compare effects of ads with different two different claim types (i.e. claims about reduced lung cancer risk and claims about reduced risks for multiple disease) versus ads with no reduced-risk claims, and examine effects on message and product perceptions, and interest in using the smokeless tobacco products. This study will also examine how smokers' reactions/interest may vary based on the product brand, and asses prior awareness/exposure to the authorized claims.

COMPLETED
Comparing Nicotine Delivery, Subjective Effects, and Sensory Experiences of Tobacco Users Using Oral Nicotine Products and Electronic Cigarettes [ZYN Study]
Description

To pilot test the appeal of non-tobacco oral nicotine products in cigarette smokers, smokeless tobacco users, and oral nicotine users.

COMPLETED
Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention
Description

The purpose of this study is to evaluate the feasibility, acceptability and preliminary efficacy of a Scheduled Gradual Reduction (SGR) intervention via Short Message Service (SMS) text messaging plus SMS Support Messages in decreasing smokeless tobacco use in a rural population.

COMPLETED
Development of Biomarkers of Effect From Chronic Tobacco Usage
Description

This study was conducted to develop biomarkers of tobacco effect that would indicate potential harm related to tobacco consumption. To gain a better understanding of chronic effects of tobacco consumption, this cross-sectional clinical study enrolled generally healthy, adult male consumers of cigarettes (SMK), moist snuff (MSC), and no tobacco products (NTC).

COMPLETED
A Multi-Media Approach to Partner Support in Smokeless Tobacco Cessation (UCare-ChewFree)
Description

In an earlier study, the investigators developed a guidebook that taught women supportive behaviors to help their husbands/partners quit smokeless tobacco. This study will create a website using the information in the guidebook, along with interactive features, videos, and forums. The investigators will then conduct a randomized trial comparing an intervention group (receiving website access and the printed guidebook) with a delayed treatment control condition, to learn if the support intervention can effectively teach women supportive behaviors and thereby increase their partners' smokeless tobacco cessation rates.

TERMINATED
Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers
Description

This randomized clinical trial studies interest in smokeless tobacco product as a substitution for cigarettes in current smokers. Use of smokeless tobacco products may help people stop smoking. Measuring use of other sources of nicotine for cigarettes under a variety of different conditions may help determine whether and how much smokers are willing to use substitutions

COMPLETED
Telephone Counseling for Snuff Users
Description

The primary objective is to evaluate the effectiveness of telephone-based counseling in promoting smokeless tobacco cessation among residents of Minnesota. It is hypothesized that a greater proportion of individuals assigned to the proactive telephone calls will quit their use of smokeless tobacco products and all tobacco products compared to the comparison group not receiving those calls.

COMPLETED
Pilot Study to Evaluate the Safety and Efficacy of Ariva® Silver Wintergreen in Reducing Cigarette Craving in Smokers
Description

Study to determine the safety and effectiveness of Ariva® Silver Wintergreen lozenge on reducing craving for a cigarette in daily smokers.

COMPLETED
A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers
Description

Study to determine the safety and effectiveness of silver salt in Ariva® Silver Wintergreen Lozenge on discouraging smoking, by its imparting an unfavorable taste to the smoker when tobacco is smoked.