What side effects are associated with this type of intervention?

The most common treatments for smoking cessation include Nicotine Replacement Therapy (NRT), varenicline, and bupropion. NRT, which includes patches, lozenges, and gum, can cause side effects such as skin irritation (from patches), mouth soreness, and gastrointestinal issues. Varenicline may lead to nausea, insomnia, and vivid dreams, while bupropion can cause dry mouth, insomnia, and an increased risk of seizures. These treatments are generally well-tolerated, but patients should discuss potential side effects with their healthcare provider to choose the most suitable option.

What prior FDA approvals exist?

The FDA has approved several treatments for smoking cessation, primarily focusing on Nicotine Replacement Therapy (NRT) to help reduce withdrawal symptoms and cravings. NRT options include nicotine patches, gum, lozenges, nasal sprays, and inhalers. These therapies provide controlled doses of nicotine to ease the transition away from smoking. Additionally, the FDA has approved non-nicotine medications such as bupropion (Zyban) and varenicline (Chantix), which work by targeting nicotine receptors in the brain to reduce cravings and withdrawal symptoms.

What other types of research exist?

Promising novel alternatives to Nicotine Replacement Therapy for smoking cessation include: 1) Internet-based interventions and mobile apps, which provide personalized support and have shown efficacy in increasing abstinence rates. 2) Text messaging programs, such as the SmokeFreeTXT, which offer automated motivational messages and behavioral support. 3) Pharmacological treatments like varenicline and bupropion, which have been effective in clinical trials. 4) Behavioral therapies, including cognitive-behavioral therapy (CBT) and mindfulness-based interventions, which help manage cravings and withdrawal symptoms. 5) Proactive telephone counseling, which has demonstrated higher quit rates compared to standard care.

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Nicotine Replacement Therapy

Nicotine Replacement Therapy for Smoking Cessation (CAN-DOSE Trial)

Phase 2

Waitlist Available

Led By Amanda Palmer

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18yrs +

Daily nicotine-containing e-cigarette user (25+ days per previous month)

Must not have

Medical conditions contraindicated to NRT use (including pregnancy, past month myocardial infarction, current cardiac arrhythmia, current angina, uncontrolled vascular disease, or medical conditions in which consumption of phenylalanine is contraindicated)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 28, day 56

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if nicotine patches and lozenges can help people who both smoke and vape to quit. It compares different doses to see which works best. The goal is to find an effective way to help dual users stop using tobacco products. Nicotine patches and lozenges have been studied extensively as aids to help people stop smoking, with various studies indicating their potential effectiveness.

Who is the study for?

The CAN-DOSE study is for adults over 18 who use nicotine e-cigarettes daily and smoke cigarettes weekly, wanting to quit both within a month. They must be willing to use nicotine replacement therapy (NRT) and have no medical conditions that make NRT unsafe, like recent heart issues or pregnancy.

What is being tested?

This study tests whether using nicotine patches and lozenges can help people stop smoking and vaping. It compares the effectiveness of regular versus higher doses of these medications in aiding cessation.

What are the potential side effects?

Possible side effects from the nicotine patch and lozenge include skin irritation at the patch site, sleep problems, headache, nausea, dizziness, racing heartbeat, muscle pain or stiffness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I use nicotine e-cigarettes daily.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have heart issues, uncontrolled vascular disease, or conditions affected by phenylalanine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 28, day 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 28, day 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28, day 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Days of dual use abstinence

Secondary study objectives

Feasibility/Acceptability

Reduction

Safety

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Arm AActive Control1 Intervention

21mg patch, qd + 4mg lozenge prn \[minimum of 5 \& up to 20 per day\]

Group II: Arm BActive Control1 Intervention

21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 \& \[up to 30 per day\]

Group III: Arm CActive Control1 Intervention

2 x 21mg patches qd + 4mg lozenges prn \[minimum of 5 \& up to 40 per day\]

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Nicotine Replacement Therapy (NRT) helps smoking cessation by delivering controlled doses of nicotine to the body, reducing withdrawal symptoms and cravings without the harmful chemicals found in tobacco smoke. This controlled nicotine delivery can be achieved through patches, lozenges, and nasal sprays. Understanding these mechanisms is crucial for patients as it shows how NRT can manage physical dependence on nicotine, thereby increasing the likelihood of successfully quitting smoking.

Nicotine Replacement Therapy: An Overview.The natural history of efforts to stop smoking: a prospective cohort study.Randomized controlled trial of behavioral activation smoking cessation treatment for smokers with elevated depressive symptoms.