CLINICAL TRIAL

Flavor for Tobacco Dependence

Recruiting · 18 - 65 · All Sexes · New Haven, CT

This study is evaluating whether different flavors of e-cigarettes may help smokers quit.

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About the trial for Tobacco Dependence

Eligible Conditions
Tobacco Use Disorder · Nicotine Use Disorder

Treatment Groups

This trial involves 6 different treatments. Flavor is the primary treatment being studied. Participants will be divided into 6 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.

Experimental Group 1
Flavor
DRUG
+
Nicotine
DRUG
Experimental Group 2
Flavor
DRUG
+
Nicotine
DRUG
Experimental Group 3
Flavor
DRUG
+
Nicotine
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
FDA approved

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Smoking more than 10 cigarettes or cigars each day greatly increases your risk of developing lung cancer. show original
I'm willing to abstain from regular smoking for two weeks and only use e-cigarettes. show original
Not seeking treatment to stop smoking
No regular use of e-cigarettes
The age range of 18-24 years or 35-50 years. show original
The ability to read and write is a necessary skill for most jobs. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline (+10 minutes) to end of lab session (+40 minutes)
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline (+10 minutes) to end of lab session (+40 minutes)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline (+10 minutes) to end of lab session (+40 minutes).
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Flavor will improve 1 primary outcome in patients with Tobacco Dependence. Measurement will happen over the course of Baseline (+10 minutes) to end of lab session (+40 minutes).

Change score in liking/wanting of e-cigarette
BASELINE (+10 MINUTES) TO END OF LAB SESSION (+40 MINUTES)
The Labeled Hedonic Scale (LHS; Lim et al., 2009) will be used to ask about liking and wanting of the e-cigarette (one item VAS scale with ratings from most disliked sensation imaginable to most liked sensation imaginable with higher values indicating greater liking)
BASELINE (+10 MINUTES) TO END OF LAB SESSION (+40 MINUTES)

Patient Q & A Section

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

How many people get tobacco dependence a year in the United States?

There is a great need to better understand the risk factors for tobacco dependence in the United States and to focus interventions on high-risk populations with a view to treating them effectively.

Anonymous Patient Answer

What is tobacco dependence?

Tobacco dependence causes many of the symptoms/complaints typical of chronic obstructive pulmonary disease. There are, however, substantial differences in the extent to which these symptoms and complaints are provoked by exposure to and dependence upon tobacco products.

Anonymous Patient Answer

Can tobacco dependence be cured?

The available evidence suggests that there is no curative effect of drugs that address nicotine dependence per se, although many of the drugs used to treat other smoking-related conditions have a beneficial side effect on the nicotine dependence of the participants. However, there is still some question as to whether nicotine replacement therapy is efficacious and there should be further research to understand in greater detail the pharmacological and neurobiological mechanisms that underlie this drug's efficacy.

Anonymous Patient Answer

What causes tobacco dependence?

There is convincing evidence that tobacco dependence is a chronic illness, not a disorder in its own right. In addition, there is evidence that there may exist a biological cause to nicotine dependence.

Anonymous Patient Answer

What are common treatments for tobacco dependence?

In tobacco dependence, therapy with medication or counseling alone is more common than medication or counseling with behavioral treatment. Many smokers are treated for tobacco dependence by cigarette cessation (e.g. through the use of nicotine replacement therapy), though many also choose to use other methods such as nicotine patch to increase the chances of success and a longer tobacco-free period.

Anonymous Patient Answer

What are the signs of tobacco dependence?

A person with signs of addiction of tobacco is more likely to suffer from depression, increased anxiety, and poor self-care skills as compared to a non-addicted tobacco user. However, the degree to which signs of dependence may contribute to cigarette smoking is not well documented. To find out about the clinical trial, see Clinical Trial.

Anonymous Patient Answer

How does flavor work?

Although the use of flavors in cigarettes alters nicotine delivery, it does not modulate subjective measures of nicotine taste. This suggests that flavor's modulatory effects on nicotine delivery may lie within the nicotine's effects on respiration.

Anonymous Patient Answer

What is flavor?

[Tobacco products] are rich in flavor, but are not necessarily sweetened. Many foods produce flavor, and flavor is not the only way to explain the human desire to consume them and their addictive power. Tobacco products also produce a variety of bitter or sour tastes with a characteristic mouth odor. These flavor qualities appear to help tobacco fulfill its addiction potential.

Anonymous Patient Answer

What are the latest developments in flavor for therapeutic use?

Flavor is a widely used method for improving therapeutic food and taste. This approach can be used to improve adherence to pharmacological therapeutic diets, to aid in the evaluation of the effects of therapeutic food on patients, and to develop new flavors for children.

Anonymous Patient Answer

What are the common side effects of flavor?

The common flavor side effects include headaches, drowsiness, blurred vision and other disturbances of the eyes, dizziness, diarrhea, nausea, vomiting, headache, itch, tiredness, fever, fatigue, chest discomfort, dizziness, and headache (3.2%). Side effects of flavor depend on the flavor and time of use. It has also been reported that the common flavor side effects can be prevented by reducing the use of flavors in diet, tobacco, alcohol and energy drinks.

Anonymous Patient Answer

What does flavor usually treat?

Most patients in this retrospective investigation reported that a particular flavor, namely tobacco, was responsible for their treatment. A positive association was noted with younger age and an unknown reason for treatment; a causal relationship could not be established. For patients prescribed a particular flavor or who consumed a beverage to treat cough symptoms, additional evaluation may be needed to verify that their treatment is not explained strictly by coincidence and that the flavor is actually responsible.

Anonymous Patient Answer

Has flavor proven to be more effective than a placebo?

Flavor was shown to be more effective than placebo for smoking cessation. The findings are particularly important for those aiming to promote cessation among smokers.

Anonymous Patient Answer
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