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Electronic Cigarettes for Tobacco Use Disorder (SHINE Trial)

Phase 4
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

SHINE Trial Summary

This trial will test whether electronic cigarettes help methadone-maintained smokers quit smoking.

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.Check my eligibility
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.See study design
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.

SHINE Trial 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.

SHINE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
FEV1 Lung Functioning
FEV1 Lung Functioning for Complete Switchers
FEV1/FVC Ratio Lung Functioning
+7 more

SHINE 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.

Find a Location

Who is running the clinical trial?

Butler HospitalLead Sponsor
129 Previous Clinical Trials
16,178 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,490 Total Patients Enrolled
15 Trials studying Nicotine Addiction
2,130 Patients Enrolled for Nicotine Addiction

Media Library

Electronic Cigarette (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05206435 — Phase 4
Nicotine Addiction Research Study Groups: Nicotine Lozenges, Electronic Cigarettes
Nicotine Addiction Clinical Trial 2023: Electronic Cigarette Highlights & Side Effects. Trial Name: NCT05206435 — Phase 4
Electronic Cigarette (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05206435 — Phase 4

Frequently Asked Questions

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

Does this clinical trial accommodate minors?

"As per the prerequisites for trial participants, individuals must be of a minimum age of 21 and no more than 65 years old."

Answered by AI

Is it possible to join this experiment at the present time?

"According to clinicaltrials.gov, the recruitment process for this medical trial is ongoing having been first posted on March 31st 2022 and most recently tweaked on September 15th 2022."

Answered by AI

Is participation in this clinical experiment open to the public?

"This trial is accepting 240 individuals aged 21 to 65 who are dependent on tobacco. Participants must demonstrate moderate-heavy smoking (10 cigarettes/day for >1 year; breath CO> 10 ppm); be enrolled in methadone treatment for 3+ months; visit the clinic weekly to receive doses of methadone; converse fluently in English; have a telephone or access to one at all times; commit 6 weeks toward this project and show interest by switching from traditional cigarettes to electronic alternatives or nicotine replacement therapy."

Answered by AI

How many individuals are being enrolled in this medical experiment?

"Affirmative. According to clinicaltrials.gov, this trial's recruitment process is ongoing since its inception on 3/31/2022 with the latest changes made on 9/15/2022. 240 individuals are needed from one medical centre for this project."

Answered by AI

Can long-term use of Electronic Cigarettes be considered a safe option for patients?

"Electronic Cigarettes were assigned a score of 3 due to the product having already gone through Phase 4 trials, and thus being approved."

Answered by AI

Who else is applying?

What site did they apply to?
Butler Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Methadone-Maintained Smokers Switching to E-Cigarettes
Michael Stein, MD 2022. "Methadone-Maintained Smokers Switching to E-Cigarettes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05206435.
~18 spots leftby Jun 2024
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