What side effects are associated with this type of intervention?

The most common treatments for smoking cessation include Electronic Nicotine Delivery Systems (ENDS) and Contingent Incentives (CI). ENDS, such as e-cigarettes, can cause side effects like throat and mouth irritation, coughing, and nausea. Long-term effects are still being studied, but there are concerns about potential respiratory and cardiovascular risks. Contingent Incentives, which involve providing rewards for smoking cessation, generally have fewer direct physical side effects but may lead to psychological effects such as stress or anxiety if the incentives are not met. Combining these methods with behavioral support can enhance effectiveness but may also introduce additional side effects related to the behavioral interventions used.

What prior FDA approvals exist?

The FDA has approved several pharmacotherapies for smoking cessation, including nicotine replacement therapies (NRTs) such as nicotine patches, gums, lozenges, nasal sprays, and inhalers. Additionally, bupropion (Zyban) and varenicline (Chantix) are non-nicotine medications approved for this purpose. These treatments aim to reduce withdrawal symptoms and cravings. More recently, electronic nicotine delivery systems (ENDS), such as e-cigarettes, have been studied as alternative nicotine delivery methods, although they are not yet FDA-approved for smoking cessation. Behavioral reinforcement strategies, like contingent incentives, have also been explored to encourage smoking cessation by providing rewards for meeting specific cessation milestones.

What other types of research exist?

Promising, novel alternatives to Electronic Nicotine Delivery Systems and Contingent Incentives for smoking cessation include motivational interviewing techniques, the 5 R's model, and technology-enhanced delivery methods like mobile chat-based support and web-based CBT interventions. These approaches focus on increasing intrinsic motivation, providing personalized support, and leveraging technology to enhance accessibility and effectiveness.

← Back to Search

E-cigarettes + Incentives for Smoking Cessation (THRIVE Trial)

N/A

Waitlist Available

Led By Cara M Murphy, Ph.D.

Research Sponsored by Brown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

willing to use ENDs for 6 weeks

21 or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed 4, 6, and 12 weeks follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if e-cigarettes and rewards can help overweight or obese smokers reduce or quit smoking. E-cigarettes are seen as a safer option, and rewards aim to motivate quitting. E-cigarettes have been suggested to help with smoking cessation or reduction.

Who is the study for?

This trial is for adults over 21 with a BMI of 25 or higher who smoke at least 5 cigarettes daily and are willing to try vaping e-cigarettes (ENDS) for smoking cessation. They must have a smartphone/tablet, not be pregnant/nursing, not planning to quit smoking soon, nor using ENDS frequently or undergoing other cessation treatments.

What is being tested?

The study tests if providing electronic nicotine delivery systems (ENDS) and offering money rewards based on breath test results can help overweight/obese smokers cut down. Participants will get risk info about ENDS vs cigarettes, some will receive ENDS for six weeks, and incentives vary by carbon monoxide levels in their breath.

What are the potential side effects?

While the trial description does not specify side effects, common ones associated with using ENDS may include throat/mouth irritation, coughing, nausea, headache or increased heart rate. The impact of contingent incentives on behavior is also being studied but isn't typically associated with physical side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am willing to use a specific device for 6 weeks.

Select...

I am 21 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed 4, 6, and 12 weeks follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed 4, 6, and 12 weeks follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed 4, 6, and 12 weeks follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Use of Cigarettes and ENDS

Within-Treatment Smoking Abstinence

Secondary study objectives

Carbon monoxide (CO)

Cigarette and E-Cigarette Dependence

Comparing E-Cigarettes and Cigarettes Questionnaire

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: No ENDS and NIExperimental Treatment2 Interventions

Participants in this arm will receive information about the comparative risk of electronic nicotine devices (ENDs) relative to smoking and will receive monetary incentives for providing breath samples only (non-contingent on smoking status).

Group II: No ENDS and CIExperimental Treatment2 Interventions

Participants in this arm will receive information about the comparative risk of electronic nicotine delivery systems (ENDS) relative to smoking and will receive 4 weeks of monetary incentives for complete abstinence from smoking (after a controlled ramp down of smoking).

Group III: ENDS and NIExperimental Treatment2 Interventions

Participants in this arm will receive information about the comparative risk of electronic nicotine delivery systems (ENDS) relative to smoking as well as 6 weeks' worth of provisions of ENDS and will receive monetary incentives for providing breath samples only (non-contingent on smoking status).

Group IV: ENDS and CIExperimental Treatment2 Interventions

Participants in this arm will receive information about the comparative risk of electronic nicotine delivery systems (ENDS) relative to smoking as well as 6 weeks' worth of provisions of ENDS and will receive 4 weeks of monetary incentives for complete abstinence from smoking (after a controlled ramp down of smoking).

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Electronic Nicotine Delivery Systems (ENDS), such as e-cigarettes, work by providing nicotine without the harmful tar and chemicals found in traditional cigarettes, helping to reduce withdrawal symptoms and cravings. This can make it easier for smokers to transition away from smoking. Contingent Incentives involve providing rewards or incentives based on achieving specific smoking cessation milestones, such as reduced carbon monoxide levels. This behavioral reinforcement encourages adherence to cessation efforts by offering tangible rewards for progress. Both methods are important as they address different aspects of addiction: ENDS focus on the physiological dependence on nicotine, while Contingent Incentives target behavioral patterns, making them complementary strategies for supporting smoking cessation patients.

An international survey: Tobacco smoking cessation strategies within left ventricular assist device centers.Brief handgrip and isometric exercise intervention for smoking cessation: A pilot randomized trial.Treatment models for targeting tobacco use during treatment for cannabis use disorder: case series.