E-Cigarettes + Nicotine Patch for Nicotine Addiction

MZ
AC
Overseen ByAmy C Janes, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Mclean Hospital
Must be taking: Nicotine Replacement Therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether electronic cigarettes, combined with nicotine patches, can reduce cravings triggered by smoking-related cues. It targets individuals who have smoked daily for the past six months and are interested in nicotine replacement therapy. Participants will use both treatments for 2 to 3 weeks to determine if this combination helps manage smoking triggers. As an unphased trial, it provides an opportunity to investigate new methods for managing smoking cravings with innovative treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that nicotine, present in both patches and e-cigarettes, is addictive and carries risks. However, it is not the primary cause of smoking-related diseases. Studies indicate that nicotine can increase the risk of heart, lung, and stomach issues. Despite these risks, nicotine treatments help people quit smoking and are generally safe when used correctly. Although some health risks exist, these treatments are often considered safer than smoking cigarettes. Always follow health professionals' advice when using nicotine products.12345

Why are researchers excited about this trial?

Researchers are excited about the combination of e-cigarettes and nicotine patches for nicotine addiction because it offers a dual approach that leverages both traditional and modern methods. Unlike standard treatments, which often rely on either nicotine replacement therapy like patches or behavioral support, this treatment pairs the steady nicotine delivery from patches with the immediate relief e-cigarettes provide. This dual method could potentially address both the physical and habitual aspects of smoking, making it a promising option for those struggling to quit.

What evidence suggests that this trial's treatments could be effective for nicotine addiction?

Research has shown that using e-cigarettes along with nicotine patches can help people quit smoking. In this trial, participants will receive both e-cigarettes and nicotine patches as part of the treatment. Studies have found that adding e-cigarettes to patches increases the chances of quitting after six months compared to using patches alone. Specifically, one study showed that e-cigarettes were more effective, with a quit rate of 6.8% compared to 3.6% for patches. Using both e-cigarettes and patches can raise quit rates from 10% to 17%. Overall, combining these treatments offers a better chance of quitting smoking than using just one method.678910

Who Is on the Research Team?

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Amy C Janes, PhD

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-45 who smoke cigarettes daily, have a carbon monoxide level indicating regular smoking, and show some nicotine dependence. Participants must be willing to use Nicotine Replacement Therapy and e-cigarettes for 2-3 weeks, speak English, and pass an MRI safety screening.

Inclusion Criteria

You have smoked cigarettes every day for the past 6 months.
I am willing to use Nicotine Replacement Therapy and e-cigarettes for 2-3 weeks.
You must give your written permission to take part in the study.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a combination of nicotine replacement therapy (NRT) and non-nicotine containing electronic cigarettes to assess reduction in smoking cue reactivity

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Dual nicotine patch and electronic cigarette

Trial Overview

The study aims to see if using both nicotine patches and electronic cigarettes can help reduce the urge to smoke when exposed to cues related to smoking. It involves monitoring reactions during an MRI scan.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Dual nicotine patch and electronic cigaretteExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials
221
Recruited
22,500+

Citations

Nicotine patches used in combination with e-cigarettes ...

Combined data from the trials showed that using a nicotine e-cigarette significantly increased smoking abstinence at 6 months compared with using a nicotine- ...

Nicotine Addiction and Smoking: Health Effects and ... - NCBI

Rates of smoking cessation may increase from 10% in control groups to 17% in persons using any form of NRT, and using 2 types of NRT is more ...

Electronic cigarettes versus nicotine patches for smoking ...

e-cigarettes were more effective than patches (6.8% versus 3.6%; RR = 1.93, 95%CI: 1.14–3.26, P = 0.02). Safety outcomes included adverse ...

Quick Take: Nicotine patches used in combination with e- ...

1. The use of nicotine e-cigarettes in addition to conventional nicotine patches may result in a modest improvement in smoking cessation ...

Baker 2016_3.pdf

This study showed that the nicotine patch, varenicline, or C-NRT are all effective in helping motivated smokers to quit smoking over a period of one year.

Nicotine

Nicotine is an alkaloid found primarily in plants of the nightshade family, notably in tobacco; Nicotine is used recreationally for its stimulant and ...

Nicotine Is Why Tobacco Products Are Addictive

Nicotine is a highly addictive chemical compound present in a tobacco plant. All tobacco products contain nicotine, including cigarettes, non- ...

The facts about nicotine

Nicotine is a chemical that occurs naturally in tobacco. It is addictive and is not risk-free. However, it is not the primary cause of smoking-related diseases.

Harmful effects of nicotine - PMC - NIH

Nicotine poses several health hazards. There is an increased risk of cardiovascular, respiratory, gastrointestinal disorders.

Nicotine

Nicotine is the addictive drug in tobacco products. Cigarettes, cigars, smokeless tobacco and nearly all e-cigarettes contain nicotine.