E-Cigarettes + Nicotine Therapy for Smoking Cessation

(CRESCENT Trial)

Overseen By CRESCENT Study Research Staff

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brown University

Must not be taking: Weight loss medications

Disqualifiers: Mental illness, Heart event, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how alternative nicotine products, such as e-cigarettes and nicotine patches or gum, help people quit smoking and manage weight gain. Participants will join one of three groups: e-cigarette use, nicotine replacement therapy, or no nicotine product. The trial is ideal for individuals who smoke at least five cigarettes a day, are considered obese, and are ready to try e-cigarettes or nicotine therapy for eight weeks. As an unphased trial, it offers a unique opportunity to contribute to understanding how these products can aid in smoking cessation and weight management.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using prescription weight loss medication, you must have stopped it at least 30 days before joining the trial.

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

Previous studies have found electronic cigarettes to be safer than regular cigarettes and at least as safe as other nicotine therapies. However, they expose users to some harmful substances and can increase the risk of breathing problems and nicotine addiction. While not without risks, they are considered less harmful than traditional smoking.

Research shows that nicotine replacement therapy (NRT) is generally safe, with side effects that are uncomfortable but not dangerous. The FDA has approved NRT to help people quit smoking, indicating it is well-tolerated by many users. Although some mild side effects might occur, they are not life-threatening.

Both treatments carry risks but are generally considered safer alternatives to smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore new ways to help people quit smoking. Unlike traditional nicotine replacement therapies like patches or gum, electronic cigarettes (EC) offer a unique delivery method that simulates the act of smoking, potentially making it easier for smokers to transition away from cigarettes. Additionally, nicotine replacement therapy (NRT) provides a controlled way to gradually reduce nicotine dependence. By comparing these treatments to a no-product control group, researchers hope to uncover insights into how these different approaches might work together or separately to enhance smoking cessation efforts.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

This trial will compare the effectiveness of electronic cigarettes (e-cigarettes) and nicotine replacement therapy (NRT) for smoking cessation. Research has shown that e-cigarettes can help people quit smoking more effectively than traditional NRT. Studies have found that e-cigarettes lead to higher quit rates compared to both NRT and non-nicotine options. For example, one study discovered that people using e-cigarettes were more successful in quitting smoking than those using NRT, with a relative risk (a measure of likelihood) of 1.59. NRT is also effective, helping about 10.7% more smokers quit compared to those not using it. Both e-cigarettes and NRT have shown promise in helping people stop smoking, but e-cigarettes might have a slight advantage according to the data. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 21 who are obese (BMI ≥ 30), smoke at least 5 cigarettes a day, and have not tried to quit smoking or used weight loss medication recently. Participants need access to a Bluetooth-enabled device and must be willing to use e-cigarettes or nicotine replacement therapy for 8 weeks.

Inclusion Criteria

Access to a Bluetooth-enabled smartphone/tablet (to permit remote measurement of CO and other outcome variables)

Smoked ≥ 5 cigarettes/day during the past year

Exhaled breath carbon monoxide (CO) level > 6 ppm at Baseline (BL) (to confirm self-reported smoking)

Exclusion Criteria

Received smoking cessation treatment of any kind in the past 30 days (actively quitting smoking)

Residing with another person currently enrolled in the study

Pregnant, nursing, or planning to become pregnant in the next 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive electronic cigarettes, nicotine replacement therapy, or no-product control for 8 weeks

8 weeks

Follow-up

Participants are monitored for smoking cessation, weight, and other health outcomes

3 months

Assessments at 1, 2, and 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Electronic Cigarettes
• Nicotine replacement therapy

Trial Overview The study is examining the impact of electronic cigarettes (EC) and nicotine replacement therapy (NRT) on helping people quit smoking without gaining weight. It will measure changes in smoking habits, body weight, and other related factors.

How Is the Trial Designed?

Group I: Nicotine Replacement Therapy Condition Experimental Treatment 1 Intervention

Participants in this condition will receive the NRT intervention.

Group II: Electronic Cigarette (EC) Condition Experimental Treatment 1 Intervention

Participants in this condition will receive the EC intervention.

Group III: No-Product Control Condition (CON) Active Control 1 Intervention

Participants in this condition will not receive any alternate nicotine product.

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Published Research Related to This Trial

In a study of 400 smokers, using a nicotine inhaler combined with a nicotine patch led to significantly higher smoking cessation rates compared to using the inhaler with a placebo patch, with 60.5% abstinence at 6 weeks versus 47.5%.

The combination therapy not only improved cessation rates but also showed a trend toward better lung function and reduced respiratory symptoms in those who quit smoking, indicating its potential benefits for overall respiratory health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial. Bohadana, A., Nilsson, F., Rasmussen, T., et al.[2019]

In a study of 150 participants, e-cigarettes were found to be as effective as nicotine gum for smoking cessation, with no significant differences in overall abstinence rates.

E-cigarettes were associated with a higher proportion of participants showing smoking reduction at 24 weeks and had fewer adverse events compared to nicotine gum, suggesting they may be a safer alternative for nicotine replacement therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Electronic Cigarettes on Smoking Reduction and Cessation in Korean Male Smokers: A Randomized Controlled Study. Lee, SH., Ahn, SH., Cheong, YS.[2020]

A systematic review of six randomized controlled trials found no significant difference in smoking cessation rates between electronic nicotine delivery systems (ENDS) and traditional nicotine replacement therapies (NRT), indicating that ENDS may not be more effective for quitting smoking.

The overall quality of evidence was rated as low or very low, highlighting the need for further research to better understand the effectiveness and safety of ENDS compared to NRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation in individuals who use vaping as compared with traditional nicotine replacement therapies: a systematic review and meta-analysis. Pound, CM., Zhang, JZ., Kodua, AT., et al.[2023]

E-cigarettes were found to be more effective than nicotine-replacement therapy (NRT) for achieving continuous smoking abstinence for 6 months or longer, with a relative risk of 1.67 based on a meta-analysis of 5 randomized controlled trials involving 1748 participants.

There were no significant differences in adverse events between e-cigarettes and NRT, except for increased throat irritation associated with e-cigarettes, indicating a similar safety profile overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic cigarettes versus nicotine-replacement therapy for smoking cessation: A systematic review and meta-analysis of randomized controlled trials. Li, J., Hui, X., Fu, J., et al.[2022]

From 1969 to 2002, the FDA's Adverse Event Reporting System documented about 2.3 million reports of adverse drug reactions across approximately 6000 marketed drugs, highlighting its role in drug safety surveillance.

Over this period, more than 75 drugs were withdrawn from the market due to safety concerns, and 11 drugs required special prescription or distribution restrictions, demonstrating the system's effectiveness in identifying serious safety issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions. Wysowski, DK., Swartz, L.[2022]

In 2006, several drugs were associated with significant safety concerns, including cardiovascular events linked to erythropoietins and macular edema associated with rosiglitazone, highlighting the need for careful monitoring by prescribers.

Other notable adverse reactions included serious complications from aprotinin, long-term use of linezolid, and congenital anomalies linked to paroxetine and lamotrigine, emphasizing the importance of understanding the safety profiles of medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacovigilance and teratovigilance]. Livio, F., Buclin, T., Biollaz, J.[2013]

Effective clinical drug safety surveillance is crucial for protecting public health and ensuring the commercial success of pharmaceutical products, as it helps monitor and manage adverse drug events.

The process of drug safety surveillance is governed by FDA regulations and involves systematic management of adverse event reports, emphasizing the importance of clear communication and data handling to improve drug safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations. Allan, MC.[2019]

The safety profile of newly approved drugs is often less established than their efficacy before they are marketed, relying heavily on voluntary reporting of adverse events by healthcare providers and patients.

The FDA has been using various epidemiological studies and has implemented initiatives for active surveillance to better identify and investigate safety signals associated with marketed drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informatic tools and approaches in postmarketing pharmacovigilance used by FDA. Weaver, J., Willy, M., Avigan, M.[2021]

In a study of 6,794 cigarette-only users, the cessation rates for electronic nicotine delivery systems (ENDS), nicotine replacement therapy (NRT), and non-NRT medications were found to be similar, with no significant differences in effectiveness (around 16% for ENDS and NRT, and 17.7% for non-NRT).

A concerning finding was that 37.6% of those who used ENDS to quit smoking became dual users of ENDS and cigarettes, highlighting the potential risk of continued nicotine dependence and the need for smokers to rely on FDA-approved cessation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of ENDS, NRT and medication for smoking cessation among cigarette-only users: a longitudinal analysis of PATH Study wave 3 (2015-2016) and 4 (2016-2017), adult data. Kaplan, B., Galiatsatos, P., Breland, A., et al.[2023]

Nicotine e-cigarettes were found to be more effective for smoking cessation compared to licensed nicotine replacement therapies (NRT), with participants using e-cigarettes being 49% more likely to remain abstinent from smoking than those using NRT.

The review included 7 e-cigarette trials with a total of 5,674 participants and 9 NRT trials with 6,080 participants, but many e-cigarette studies had a moderate to high risk of bias, indicating a need for more rigorous research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of randomized controlled trials and network meta-analysis of e-cigarettes for smoking cessation. Chan, GCK., Stjepanović, D., Lim, C., et al.[2023]

Citations

1. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-024-02572-7

Effectiveness of e-cigarettes as a stop smoking intervention in ... This systematic review aims to identify the benefits and harms of electronic cigarettes (e-cigarettes) as a smoking cessation aid in adults (aged ≥ 18 years)

2. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD010216.pub9/full

Electronic cigarettes for smoking cessation - Lindson, N Nicotine EC results in increased quit rates compared to nicotine replacement therapy (NRT) (high‐certainty evidence) (RR 1.59, 95% CI 1.30 to ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38189560/

Electronic cigarettes for smoking cessation Nicotine e-cigarettes increase quit rates compared to NRT and non-nicotine e-cigarettes, and may also increase quit rates compared to no ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2308815

Electronic Nicotine-Delivery Systems for Smoking Cessation Outcomes. The primary outcome was continuous abstinence from tobacco smoking at 6 months as measured by participant report of no cigarette ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0376871624014455

Examining e-cigarettes as a smoking cessation treatment The analysis found that in 8 of 11 comparisons, e-cigarettes were more effective, and 3 of 11 comparisons reported no statistically significant ...

6. cdc.gov cdc.gov/tobacco/e-cigarettes/health-effects.html

Health Effects of Vaping | Smoking and Tobacco Use No tobacco products, including e-cigarettes, are safe. Most e-cigarettes contain nicotine, which is highly addictive and is a health danger for ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6179561/

Safety and Efficacy of Electronic Cigarettes: A Review - PMC Electronic cigarettes are safer than conventional cigarettes and at least as safe as other approved nicotine replacement therapies.

8. tobaccocontrol.bmj.com tobaccocontrol.bmj.com/content/33/3/373

Risk and safety profile of electronic nicotine delivery systems ... We found high-level evidence that ENDS exposes users to toxic substances; increases the risk of respiratory disease; leads to nicotine dependence; causes ...

9. who.int who.int/news-room/questions-and-answers/item/tobacco-e-cigarettes

Tobacco: E-cigarettes What role do ENDS play in smoking cessation? E-cigarettes as consumer products have not been proven to be effective for cessation at the population level.