Electronic Cigarettes for Smoking

(SWITCH Trial)

IP
Overseen ByIrene Pericot-Valverde, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Prisma Health-Upstate
Must be taking: Buprenorphine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different e-cigarette flavors and usage can help cigarette smokers with opioid use disorder reduce harm. Participants will receive a 12-week supply of either sweet-cooling, sweet non-cooling, or tobacco-flavored e-cigarette liquids, along with brief individual counseling sessions, to encourage switching from regular cigarettes to e-cigarettes. It targets individuals who smoke cigarettes daily, have done so for at least a year, and are stable on buprenorphine, a medication for opioid use disorder. The trial excludes those who have recently attempted to quit smoking or frequently use other tobacco products. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could lead to new harm reduction strategies.

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

The trial does not specify if you need to stop taking your current medications, but it does require that you are stable on buprenorphine treatment. It seems you can continue with buprenorphine, but other medications are not mentioned.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that while electronic cigarettes (ECs) are often seen as less harmful than regular cigarettes, they still pose risks. Studies have found that EC use can expose users to harmful substances like metals and chemicals, originating from the ingredients and the heating process of the e-liquid. The FDA considers the flavoring and cooling agents in ECs safe when used in food, but their safety when inhaled through vaping remains unclear.

For ECs with sweet and cooling flavors, concerns exist about inhaling cooling agents, even though they are generally safe as food additives. Sweet flavors without cooling agents also carry health risks, similar to other e-cigarettes. These sweet flavors are very popular, especially among young people, but they are not risk-free.

In summary, while ECs might be safer than regular cigarettes, they still present potential health risks. Understanding these risks can help individuals make informed decisions about participating in trials involving ECs.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore the potential of electronic cigarettes (ECs) as a smoking cessation aid, paired with brief counseling sessions. Unlike traditional nicotine replacement therapies like patches or gum, these treatments use flavored EC liquids, which may offer a more appealing experience for smokers trying to quit. The trial includes a unique sweet-cooling EC liquid and a sweet non-cooling variant, which could make the switch from regular cigarettes more satisfying, potentially increasing the success rate of quitting. Additionally, the tobacco-flavored EC option provides an alternative that mimics the taste of regular cigarettes, helping smokers transition more smoothly. By investigating these innovative approaches, researchers hope to find out if these EC flavors combined with counseling can improve quitting outcomes compared to standard methods.

What evidence suggests that this trial's treatments could be effective for smoking cessation in individuals with opioid use disorder?

This trial will compare different types of electronic cigarettes (EC) combined with counseling to help participants quit smoking. Research has shown that people using sweet-flavored e-cigarettes are more likely to quit smoking than those using tobacco-flavored ones. One study found that about 26% of people reduced or quit smoking after using flavored e-cigarettes. Participants in this trial may receive sweet-cooling EC, sweet non-cooling EC, or tobacco-flavored EC, each paired with counseling sessions. Users of sweet non-cooling e-cigarettes are more likely to cut down or quit smoking compared to those who don't use e-cigarettes at all. Additionally, daily use of e-cigarettes is linked to higher quitting rates. Overall, flavored e-cigarettes seem to help people reduce or stop smoking more effectively than traditional tobacco flavors.678910

Are You a Good Fit for This Trial?

This trial is for cigarette smokers who are also dealing with opioid use disorder and currently taking buprenorphine. The study aims to help them reduce harm from smoking through the use of e-cigarettes.

Inclusion Criteria

Smoke ≥5 CPD for ≥1 year
Daily CC smoker
Exhaled CO ≥6 ppm
See 8 more

Exclusion Criteria

Interested in quitting CC (contemplation stage of change)
Use of other tobacco products (e.g., cigars, smokeless tobacco) on ≥9 days of the past 30 days
Medical condition that would contraindicate participation
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week supply of electronic cigarette liquid and counseling sessions

12 weeks
5 visits (in-person)

Follow-up

Participants are monitored for changes in cigarette consumption and carbon monoxide levels

14 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Brief individual counseling sessions
Trial Overview The focus of this trial is on how different flavors and usage patterns of e-cigarettes might help participants cut down on smoking cigarettes, as part of a strategy to reduce overall harm while managing opioid dependence.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Sweet-Cooling EC + CounselingExperimental Treatment1 Intervention
Group II: Sweet non-cooling EC + CounselingExperimental Treatment1 Intervention
Group III: Tobacco-flavored EC + CounselingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Prisma Health-Upstate

Lead Sponsor

Trials
91
Recruited
47,500+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Citations

Impact of non-menthol flavours in e-cigarettes on ...Compared with non-e-cigarette users, users of non-tobacco/menthol e-cigarette flavours were more likely to have reduced or quit smoking cigarettes in the past ...
The role of flavored electronic nicotine delivery systems in ...This systematic review finds the role of different flavored ENDS use and smoking cessation outcomes is inconclusive.
Associations Between E-cigarette Use and E-cigarette Flavors ...Our findings indicate that e-cigarette non-tobacco flavors can be helpful for smoking cessation. Interestingly, we found no evidence of a difference in the odds ...
E-Cigarette Characteristics and Cigarette Cessation ...In this study, daily e-cigarette use and use of e-cigarettes in 2019 to 2021 were consistently associated with greater cigarette discontinuation rates.
"Concurrent Associations Between Sweet And Cooling E ...Participants were statistically significantly more likely to be non-abstinent from CCs on days that they had used ECs, though this relationship was cross- ...
Associations Between E-cigarette Use and ...found that, “sweet” flavored e-cigarette users were more likely to quit smoking between surveys compared with users of tobacco flavors. A cross-sectional study ...
Sweet flavours and bright colours lure youth into nicotine ...“All tobacco and nicotine products are harmful, no matter how good they taste or how appealing they look. If e-cigarettes are truly meant to ...
Adolescent, Young Adult, and Adult Use of Nonnicotine e ...This cross-sectional study evaluates nonnicotine e-cigarette use patterns, including common flavors, brands, and ingredients.
A Comprehensive Review of the Harmful Compounds in ...Electronic cigarettes, while marketed as safer alternatives to traditional tobacco, can expose users to various toxic compounds. Metals like lead and nickel, ...
Opinion on electronic cigarettesTo date, there is no specific data that specific flavourings used in the EU pose health risks for electronic cigarette users following repeated ...
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