The Moment Study: Mixed Method E-cigarette Study

NCT02261363 | Completed Results DMC

• 1 other identifier: 00008526
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

• Cigarette Use

  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

Study Arms (1)

Ecig group 1

EXPERIMENTAL

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

Interventions

Ecig group 1 OTHER

E-cigarettes were 3% nicotine and of tobacco or menthol flavor, depending on participants' usual flavor preference.

Ecig group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must:
• be aged 18 years or older
• reside in Washington, D.C. metro area (including VA and MD suburbs)
• be proficient in English
• 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.
• not taking smoking cessation medications;
• smoked LCC/cigars/hookah less than 5 times in last 30 days
• have not used other tobacco products in last 30 days
• have not used an ENDS product (electronic cigarette) in the last 30 days
• be interested in trying an ENDS
• have an iPhone or Android that allows installation of applications and use it daily
• have a phone plan that allows unlimited text messages

You may not qualify if:

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

Sponsors & Collaborators

• Truth Initiative: lead

Study Sites (1)

American Legacy Foundation

Washington D.C., District of Columbia, 20036, United States

Location

Related Publications (2)

• Harvey EJ, Rubin LF, Smiley SL, Zhou Y, Elmasry H, Pearson JL. Mobile Phone Ownership Is Not a Serious Barrier to Participation in Studies: Descriptive Study. JMIR Mhealth Uhealth. 2018 Feb 19;6(2):e21. doi: 10.2196/mhealth.8123.

  PMID: 29459355 DERIVED

• Pearson JL, Smiley SL, Rubin LF, Anesetti-Rothermel A, Elmasry H, Davis M, DeAtley T, Harvey E, Kirchner T, Abrams DB. The Moment Study: protocol for a mixed method observational cohort study of the Alternative Nicotine Delivery Systems (ANDS) initiation process among adult cigarette smokers. BMJ Open. 2016 Apr 22;6(4):e011717. doi: 10.1136/bmjopen-2016-011717.

  PMID: 27105716 DERIVED

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Jennifer Pearson
• Organization: University of Nevada, Reno

jennipearson@unr.edu

7756825005

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Investigator

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 10, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 8, 2025
• Results First Posted: May 8, 2025

Record last verified: 2025-05

Locations

US (1)