240 Participants Needed

Electronic Cigarettes for Tobacco Use Disorder

(SHINE Trial)

AA
MS
Overseen ByMichael Stein, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Butler Hospital
Must be taking: Methadone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any medications that may reduce smoking, such as bupropion, varenicline, or nicotine replacement therapy, to participate in this trial.

Is it safe to use electronic cigarettes?

Electronic cigarettes can pose safety risks, including potential nicotine poisoning and exposure to harmful chemicals. Reports suggest that they may cause acute health effects, and their long-term safety is still uncertain.12345

How does the treatment of electronic cigarettes differ from other treatments for tobacco use disorder?

Electronic cigarettes are unique because they deliver nicotine without burning tobacco, potentially reducing exposure to harmful chemicals found in traditional cigarettes. They offer a variable nicotine delivery, which can be adjusted to help manage cravings and withdrawal symptoms, unlike fixed-dose options like nicotine patches.678910

What data supports the effectiveness of the treatment Electronic Cigarette, Nicotine Lozenge, Nicorette, Commit for Tobacco Use Disorder?

Research suggests that electronic cigarettes (e-cigarettes) may help people quit smoking, as they are commonly used for smoking cessation and have shown potential in reducing tobacco withdrawal and cravings.711121314

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can go weekly to get my methadone dose.
Are available over the next 6 weeks
Have a telephone or access to a telephone
See 3 more

Exclusion Criteria

I take daily medication for asthma or COPD.
I had a heart attack or stroke in the last month.
I am currently using medication to help me stop smoking.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments include biomarker measurement, carbon monoxide (CO) readings, smoking history and current cigarette use, spirometry, respiratory symptoms, and tobacco demand

1 day
1 visit (in-person)

Treatment

Participants are randomized to either 6 weeks of EC use (JUUL 5% nicotine pods) or 6 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges

6 weeks
5 weekly check-in visits (in-person)

6-week Assessment

Baseline measurements are repeated to determine changes in health effects, biomarkers, and combustible cigarette use

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Electronic Cigarette
  • Nicotine Lozenge
Trial Overview 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.
How Is the Trial Designed?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Butler Hospital

Lead Sponsor

Trials
133
Recruited
16,700+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Published Research Related to This Trial

E-cigarettes have been shown to significantly reduce the desire to smoke and the number of cigarettes smoked per day in small clinical studies, suggesting they may help modify smoking habits.
While e-cigarettes may have fewer adverse effects compared to nicotine patches and can aid in short-term smoking reduction, there is limited evidence for their long-term effectiveness in achieving sustained smoking cessation beyond 6 months.
Efficacy of electronic cigarettes for smoking cessation.Orr, KK., Asal, NJ.[2018]
The E3 trial is a comprehensive study involving 376 participants over 12 weeks, aimed at evaluating the effectiveness of nicotine e-cigarettes compared to non-nicotine e-cigarettes and no e-cigarettes for smoking cessation, with follow-ups extending to 52 weeks.
This trial will provide crucial data on the efficacy and safety of e-cigarettes as a smoking cessation tool, helping inform healthcare professionals and regulators about their potential role in helping smokers quit.
A Randomized Controlled Trial Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation in the General Population: E3 Trial Design.Hébert-Losier, A., Filion, KB., Windle, SB., et al.[2022]
This study outlines a randomized controlled trial involving 657 participants in Auckland, New Zealand, to evaluate the efficacy and safety of nicotine e-cigarettes compared to nicotine patches and placebo e-cigarettes for smoking cessation.
The primary outcome will be the rate of biochemically verified continuous abstinence from smoking at six months, which will provide crucial data on whether e-cigarettes can serve as effective smoking cessation aids.
Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation.Bullen, C., Williman, J., Howe, C., et al.[2022]

Citations

Efficacy of electronic cigarettes for smoking cessation. [2018]
Does utilization of electronic cigarettes facilitate smoking cessation compared to other interventions? [2023]
A Randomized Controlled Trial Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation in the General Population: E3 Trial Design. [2022]
Are electronic nicotine delivery systems (ENDs) helping cigarette smokers quit?-Current evidence. [2022]
Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation. [2022]
Notes from the field: calls to poison centers for exposures to electronic cigarettes--United States, September 2010-February 2014. [2022]
Electronic cigarettes: health risks and workplace policy. [2017]
Limited mutagenicity of electronic cigarettes in mouse or human cells in vitro. [2018]
Parental Use of Electronic Cigarettes. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Toxicological assessment of electronic cigarette vaping: an emerging threat to force health, readiness and resilience in the U.S. Army. [2022]
Electronic cigarettes and nicotine dependence: evolving products, evolving problems. [2018]
Clinical laboratory assessment of the abuse liability of an electronic cigarette. [2022]
Clinical Pharmacology of Electronic Nicotine Delivery Systems (ENDS): Implications for Benefits and Risks in the Promotion of the Combusted Tobacco Endgame. [2023]
The electronic cigarette: a knight in shining armour or a Trojan horse? [2021]
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