Standardized Research E-cigarette (SREC) for Smoking, Cigarette

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Minnesota, Masonic Cancer Center, Minneapolis, MN
Smoking, Cigarette
Standardized Research E-cigarette (SREC) - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Biomarkers of Exposure and Effect in Standardized Research E-cigarette (SREC) Users

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Standardized Research E-cigarette (SREC) will improve 5 primary outcomes and 2 secondary outcomes in patients with Smoking, Cigarette. Measurement will happen over the course of 8 Weeks.

1 Year
Cigarette Avoidance
Exposure Biomarkers
NNN-derived HPB-releasing DNA adducts
Product Use
Salivary NNN
8 Weeks
Formaldehyde-DNA adducts
Oxidative DNA adduct 8-oxo-dG in DNA

Trial Safety

Trial Design

3 Treatment Groups

Usual Brand Cigarettes
1 of 3
Switching from Smoking Cigarettes to SREC
1 of 3
Switching from Smoking Cigarettes to Nicotine Mini-Lozenge
1 of 3
Active Control
Experimental Treatment

This trial requires 125 total participants across 3 different treatment groups

This trial involves 3 different treatments. Standardized Research E-cigarette (SREC) is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Switching from Smoking Cigarettes to SREC
Drug
Switching from Smoking Cigarettes to Nicotine Mini-Lozenge
Drug
Usual Brand Cigarettes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
FDA approved

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

University of Minnesota, Masonic Cancer Center - Minneapolis, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male or female smokers who are 18-65 years of age and are willing to stop smoking and completely switch to e-cigarettes or medicinal nicotine;
Report smoking ≥ 5 cigarettes daily and not using any other nicotine or tobacco product;
Biochemically confirmed regular smoking status by a NicAlert test level of 6;
Smoking daily for at least 1 year and no serious quit attempts (e.g., quit for 24 hours or longer) in the last 3 months (to ensure stability of daily smoking, particularly for those randomized to the continued smoking group);
No unstable and significant medical or psychiatric conditions as determined by medical history and Prime-MD (to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures);
Subjects are in good physical health (no unstable medical condition);
Subjects are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse);
Subjects who are not taking anti-inflammatory medications or any medications that affect relevant metabolic enzymes;
Women who are not pregnant or nursing or planning to become pregnant;
Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products).

Patient Q&A Section

What is smoking, cigarette?

"Smoking is a health risk that is causing an increasing of heart disease and lung cancer. The health risks caused by smoking is increased after one week of smoking." - Anonymous Online Contributor

Unverified Answer

What causes smoking, cigarette?

"Tolerance to the rewarding, euphoriant, and anxiolytic effects of smoking is thought to be due to epigenetic modifications and epigenetic alterations in the brain. Smoking increases expression of epigenetic regulatory enzymes, such as DNA methyltransferases and histone deacetylases. Smoking can change expression of other genes that affect dopaminergic, serotonergic, GABAergic, and/or NMDA neurons in the brain. In other brain regions, neural plasticity is altered by smoking, which contributes to nicotine addiction and increased risk of relapse. Tolerance also arises from tolerance to nicotine, which is achieved with repeated smoking." - Anonymous Online Contributor

Unverified Answer

Can smoking, cigarette be cured?

"Smoking, cigarette can not be cured. There is no cure for smoking. Cigarettes cannot be recommended as a healthy option. Cigarettes have little if any benefits in terms of health, and are an unhealthier option over and above quitting." - Anonymous Online Contributor

Unverified Answer

How many people get smoking, cigarette a year in the United States?

"20 percent of the US population smoked at some point. Among smokers, the rate of smoking was lowest for those with the lowest educational level." - Anonymous Online Contributor

Unverified Answer

What are the signs of smoking, cigarette?

"All smokers will demonstrate an increased rate of illness and more recent and severe symptoms of illness.\n\n- Lung cancers and smoking\n- Lung cancer"

"Emmetia gazella\n\nEmmetia gazella, known generally as the small emmetia or white-marked groundling, is a species of cutworm or dart moth in the family Noctuidae.\n\nThe MONA or Hodges number for "Emmetia gazella" is 9894." - Anonymous Online Contributor

Unverified Answer

What are common treatments for smoking, cigarette?

"The most common treatment for smoking, cigarette, is quitting. Effective smoking cessation means quitting by smoking less or quitting altogether and getting help from a smoking cessation program. For those who want to continue smoking, quitting can be painful, but the good news is it is also very rewarding. Improving the health of other people is another reason for smoking. As our population ages, smoking and lung cancer will be a growing problem in the future. Prevention is key: smoking causes 80% of lung cancer cases and 90% of deaths in the United States." - Anonymous Online Contributor

Unverified Answer

Has standardized research e-cigarette (srec) proven to be more effective than a placebo?

"E-cigarette use is very common among current smokers. The srec was better tolerated than the placebo and we found no significant differences between the two groups in terms of safety and effectiveness." - Anonymous Online Contributor

Unverified Answer

How does standardized research e-cigarette (srec) work?

"A relatively strong and persistent user effect was noted on the number of puffs smoked, with the effect being the strongest on the second inhalation of vapor extract. Given that standardizing the device to a single puffed extract of 100 or 200 tar might be more practical when testing products without known standards, the standardized device can serve as a useful tool in evaluating both in vivo efficacy and in vivo toxicity." - Anonymous Online Contributor

Unverified Answer

Is standardized research e-cigarette (srec) typically used in combination with any other treatments?

"A quarter of the e-cigarette users used a combination of other smoking cessation treatments. Using srec can be a useful component of most multimodal smoking cessation treatment." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving standardized research e-cigarette (srec)?

"This is the first investigation conducted to comprehensively study the efficacy and adverse-effect profile of a srec product. Results from a recent paper support the hypothesis that e-vaporized cigarettes may have the potential to simplify or even eliminate the use of traditional smoking devices, making them a desirable option for smokers." - Anonymous Online Contributor

Unverified Answer

How serious can smoking, cigarette be?

"Given the risk of developing many serious diseases and diseases of the cardiovascular system from smoking and the strong protective effect of stopping smoking, it is important for smokers to know that it is highly likely to cause premature death. Smoking cessation should be prioritized because it is important for many people who already have health problems or who are at high risk for developing many diseases. Smokers should stop smoking and not start anew. Please consult your health provider before quitting smoking and for additional help." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of smoking, cigarette?

"Results from a recent clinical trial show the substantial impact of cigarette smoking on the incidence of chronic medical conditions such as COPD and cancer and should make clinicians cautious about smoking to minimize their risk and for smokers to quit to avoid these illnesses." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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