The Moment Study: Mixed Method E-cigarette Study (Moment)

May 6, 2025 updated by: Jennifer Pearson, Truth Initiative

A Mixed Method EMA Assessment of Cognition and Behavior Among New ENDS Users: An Observational Cohort Study

The universe of tobacco products is expanding, with new noncombustible products gaining popularity even as the reduction in prevalence of cigarette smoking slows or stalls. E-cigarettes, or Electronic Nicotine Delivery Systems (ENDS), are the most prevalent of these emerging noncombustible products. With sales increasing rapidly and more efficient pulmonary delivery devices under development, ENDS are likely to play an increasing role in the future tobacco market. Little is known about the cognitions and behaviors leading to or sustaining ENDS use. Smokers may use ENDS to subvert smoking restrictions, to reduce perceived smoking harms, or for smoking cessation. Evidence about ENDS use is emerging from national surveillance and laboratory research, but the majority of information on ENDS is limited to retrospective surveys and convenience samples of White male ENDS users. The investigators research suggests Black smokers are less likely than White smokers to try and be current ENDS users, perhaps due to a greater degree of perceived harm associated with ENDS, a preference for menthol, or cultural norms. Thus, it is timely and critical to study how all smokers, including Blacks and menthol smokers, experience and initiate ENDS use employing valid, innovative research methods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20036
        • American Legacy Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Study Population

In total, our goal is to enroll 150 individuals, with 120 participants completing the protocol. For the main arm of the study, we will recruit a racially and ethnically diverse sample of 140 daily smokers (or 100 study completers), with the goal of recruiting at least 50% non-Hispanic black participants. For the second study arm, we will enroll an additional 30 participants, with the goal of 20 individuals completing the protocol. There are no race/ethnicity recruitment goals associated with the second arm. In total, the main study arm will consist of 100 daily smokers who do not intend to quit smoking in the next 30 days, while the second arm will include 20 daily smokers who do intend to quit smoking in the next 30 days.

Description

Inclusion Criteria:

Participants must:

  1. be aged 18 years or older
  2. reside in Washington, D.C. metro area (including VA and MD suburbs)
  3. be proficient in English

  4. be daily smoker with at least 5 years of established daily smoking

    • A person will be categorized as a daily smoker if he reports daily smoking of at least 8 cigarettes a day for the past 5 years, and records an exhaled air carbon monoxide (CO) level > 8 parts-per-million (ppm) at the baseline in-person meeting.
    • Daily smokers will be eligible for the main study if they do not intend to quit in the next 30 days.
    • If they do intend to quit in the next 30 days, eligible daily smokers will be enrolled in the second arm of the study.
  5. not taking smoking cessation medications;
  6. smoked LCC/cigars/hookah less than 5 times in last 30 days
  7. have not used other tobacco products in last 30 days
  8. have not used an ENDS product (electronic cigarette) in the last 30 days
  9. be interested in trying an ENDS
  10. have an iPhone or Android that allows installation of applications and use it daily
  11. have a phone plan that allows unlimited text messages
  12. be willing to travel to the data collection cite four times in three weeks
  13. not be breastfeeding or planning to become pregnant
  14. not have heart disease/uncontrolled blood pressure
  15. not have psychosis/suicidal thoughts
  16. not be currently enrolled in an alcohol treatment program
  17. not be out of town for more than 5 nights in the next 6 weeks

Exclusion Criteria:

  • Individuals who do not satisfy the criteria above will not be eligible for this study.
  • There will be no involvement of vulnerable populations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ecig group 1
On study day 6, we provided participants with two NJOY King 5-packs of cigalike e-cigarettes and asked them to take at least three puffs a day to ensure that they had some exposure to the product in the first week. On day 13, we gave participants two additional NJOY King 5-packs and instructed them to use or not use the e-cigarettes as they wished.
Other: Ecig group 1
E-cigarettes were 3% nicotine and of tobacco or menthol flavor, depending on participants' usual flavor preference.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cigarette Use
Time Frame: Study Day 7, Week 2
Change in the average number of cigarettes per day comparing average cigarettes per day on study day 6 (last day of cigarette-only use) to average cigarettes per day on study day 7 (first day of e-cigarette and cigarette use).
Study Day 7, Week 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motivation to Quit
Time Frame: 30 day follow up
Stage of Change Model
30 day follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Truth Initiative

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

October 3, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimated)

October 10, 2014

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

May 6, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 00008526

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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