What side effects are associated with this type of intervention?

Common treatments for nicotine addiction, such as nicotine replacement therapies (NRT) including patches, gums, lozenges, and electronic cigarettes (nicotine delivery through vapor inhalation), often have side effects like mild coughing, throat irritation, and mouth soreness. Varenicline, another common treatment, can cause nausea, insomnia, and vivid dreams. These side effects are generally mild and tend to decrease with regular use. However, it is important to discuss any concerns with a healthcare provider to ensure the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several pharmacotherapies for the treatment of nicotine addiction, including nicotine replacement therapy (NRT) products such as nicotine patches, gum, and lozenges. These products deliver nicotine to the body to help reduce withdrawal symptoms and cravings. Additionally, bupropion and varenicline are non-nicotine medications that have been approved for smoking cessation. While electronic cigarettes (e-cigarettes) are being studied as a method of nicotine delivery through vapor inhalation, they are not currently approved by the FDA as a smoking cessation aid.

What other types of research exist?

Promising alternatives to electronic cigarettes for nicotine addiction treatment include: 1) Varenicline combined with nicotine replacement therapy (NRT), 2) Bupropion combined with NRT, 3) Mobile apps like QuitGuide and quitSTART that offer behavioral support and motivational messaging, 4) Social network-based interventions such as Tweet2Quit, and 5) Comprehensive smoking cessation programs that include education and support groups.

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Electronic Cigarettes for Tobacco Use Disorder (SHINE Trial)

Phase 4

Waitlist Available

Research Sponsored by Butler Hospital

Eligibility Criteria Checklist

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

Must have

Attend at least weekly to receive methadone dose

Have been receiving methadone for at least three months

Must not have

Daily medication for asthma or COPD

Had a cardiovascular event in the last month

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is testing if e-cigarettes or nicotine lozenges can help smokers who are on methadone quit regular cigarettes. These smokers are highly dependent on nicotine and at risk for smoking-related health problems. The study aims to see if these methods can reduce their smoking habits and improve their health. E-cigarettes have shown potential in aiding smoking cessation, with some studies indicating higher success rates compared to traditional methods.

Who is the study for?

This trial is for moderate to heavy smokers who have been using methadone for at least three months, smoke more than 10 cigarettes a day, and are interested in switching to e-cigarettes or nicotine lozenges. They must attend weekly methadone sessions, speak English, and be reachable by phone. People can't join if they use marijuana often, are pregnant, recently had heart issues, take daily asthma/COPD meds, used e-cigs frequently last month or are on smoking-reduction drugs.

What is being tested?

The study compares the effectiveness of electronic cigarettes (JUUL with 5% nicotine pods) versus nicotine lozenges in helping methadone-maintained smokers quit traditional cigarettes. Participants will be randomly assigned to one of these two options and followed over six weeks with seven visits involving psychological assessments and biomarker tests.

What are the potential side effects?

Potential side effects from using electronic cigarettes include throat irritation, coughing, dry mouth and dependence on the device. Nicotine lozenges may cause mouth soreness, indigestion or hiccups; both methods carry the usual risks associated with nicotine intake.

Eligibility Criteria

Inclusion Criteria

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

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I can go weekly to get my methadone dose.

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I have been on methadone for at least 3 months.

Exclusion Criteria

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

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I take daily medication for asthma or COPD.

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I had a heart attack or stroke in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

FEV1 Lung Functioning

FEV1 Lung Functioning for Complete Switchers

FEV1/FVC Ratio Lung Functioning

+7 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: Nicotine LozengesActive Control1 Intervention

Participants in this arm are randomized to receive nicotine lozenge for the 6-week study period.

Group II: Electronic CigarettesActive Control1 Intervention

Participants in this arm are randomized to receive electronic cigarettes for the 6-week study period.

0 / 4Eligibility 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) works by delivering nicotine in controlled, lower doses through patches, gum, or lozenges, reducing withdrawal symptoms and cravings without the harmful effects of smoking. Varenicline acts on nicotine receptors in the brain, reducing cravings and withdrawal symptoms while also blocking the pleasurable effects of nicotine if smoking is resumed. Bupropion is an antidepressant that also helps reduce nicotine cravings and withdrawal symptoms by affecting neurotransmitters in the brain. Electronic cigarettes (ECs) deliver nicotine through vapor inhalation, mimicking the act of smoking while potentially reducing exposure to harmful chemicals found in traditional cigarettes. These treatments are crucial for nicotine addiction patients as they provide various options to manage withdrawal symptoms and cravings, increasing the likelihood of successful cessation.

Methodological issues in measuring treatment outcome in adolescent smoking cessation studies.