60 Participants Needed

E-Cigarettes + Nicotine Therapy for Smoking Cessation

(CRESCENT Trial)

CS
Overseen ByCRESCENT Study Research Staff
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

What data supports the effectiveness of the treatment E-Cigarettes + Nicotine Therapy for Smoking Cessation?

Research shows that both e-cigarettes and nicotine replacement therapy (NRT) can help people quit smoking. Some studies suggest that e-cigarettes might be as effective as NRT, providing both nicotine and a similar experience to smoking, which can help reduce cravings.12345

Is the combination of e-cigarettes and nicotine therapy safe for humans?

There is no specific safety data available for the combination of e-cigarettes and nicotine therapy in the provided research articles.678910

How is the treatment of e-cigarettes combined with nicotine therapy unique for smoking cessation?

This treatment is unique because it combines electronic cigarettes (e-cigarettes) with nicotine replacement therapy (NRT), potentially offering a more effective approach by using both methods together to help people quit smoking. This combination may provide a more comprehensive way to manage nicotine cravings compared to using either method alone.13111213

What is the purpose of this trial?

This project will investigate the effects of alternative nicotine products on smoking, weight gain, and related outcomes.

Eligibility Criteria

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)
See 3 more

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
See 5 more

Timeline

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

Treatment Details

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.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Nicotine Replacement Therapy ConditionExperimental Treatment1 Intervention
Participants in this condition will receive the NRT intervention.
Group II: Electronic Cigarette (EC) ConditionExperimental Treatment1 Intervention
Participants in this condition will receive the EC intervention.
Group III: No-Product Control Condition (CON)Active Control1 Intervention
Participants in this condition will not receive any alternate nicotine product.

Find a Clinic Near You

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+

Findings from Research

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

References

Electronic cigarettes versus nicotine-replacement therapy for smoking cessation: A systematic review and meta-analysis of randomized controlled trials. [2022]
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. [2023]
Effect of Electronic Cigarettes on Smoking Reduction and Cessation in Korean Male Smokers: A Randomized Controlled Study. [2020]
A systematic review of randomized controlled trials and network meta-analysis of e-cigarettes for smoking cessation. [2023]
Smoking cessation in individuals who use vaping as compared with traditional nicotine replacement therapies: a systematic review and meta-analysis. [2023]
Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions. [2022]
[Pharmacovigilance and teratovigilance]. [2013]
A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations. [2019]
Repurposing Potential of Ketamine: Opportunities and Challenges. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Informatic tools and approaches in postmarketing pharmacovigilance used by FDA. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial. [2019]
Assessment of formal tobacco treatment and smoking cessation in dual users of cigarettes and e-cigarettes. [2023]
Nicotine patches used in combination with e-cigarettes (with and without nicotine) for smoking cessation: a pragmatic, randomised trial. [2020]
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