Electronic Cigarettes for Tobacco Use Disorder
(SHINE 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?
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline assessments include biomarker measurement, carbon monoxide (CO) readings, smoking history and current cigarette use, spirometry, respiratory symptoms, and tobacco demand
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-week Assessment
Baseline measurements are repeated to determine changes in health effects, biomarkers, and combustible cigarette use
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Electronic Cigarette
- Nicotine Lozenge
Find a Clinic Near You
Who Is Running the Clinical Trial?
Butler Hospital
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator