Electronic Cigarette Use in Young Adult Men and Women

This one-year pilot study of 30 non-treatment seeking young adult e-cigarette/combustible tobacco product dual users (15 males/15 females) will use smartphone-based ecological momentary assessment (EMA) to gather real-time data of e-cigarette and combustible tobacco product behaviors during a 1-week cigarette/e-cigarette dual use period .(1) Participants will respond to daily random prompts assessing in-the-moment use of e-cigarettes/cigarettes and the subjective factors (ratings of satisfaction and withdrawal) and contextual factors (location, activity, social cues) associated with each episode of use. Participants will also complete daily electronic diaries to document e-cigarette use episodes/day, and satisfaction with the e-cigarette experience during the study.

Study Overview

• Status: Completed
• Conditions: Tobacco Use; Cigarette Smoking
• Intervention / Treatment: Behavioral: Survey Arm

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. be 18 through 29 years of age;
2. Smoke cigarettes;
3. have experience with e-cigarette use;
4. fluent in English;
5. have a functioning cell phone for personal use ;
6. have access to wireless networks at least once daily;
7. have self-reported good health.

Exclusion Criteria.

1. report serious medical illness;
2. are women who are currently/planning to be pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Survey Arm; Will receive incentives for completing surveys and evidence of tobacco use status daily for 1 week	Behavioral: Survey Arm; Contingency Management for completion of surveys and evidence of tobacco use status

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contextual Factors Associated With Tobacco Use Episode Reported Via Ecological Momentary Assessment	Participant responses to prompt during ecological momentary assessment about their activity, location, and companionship during a tobacco use episode that occurred within the past 15 minutes.	week 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of electronic cigarette use	Number of episodes of e-cigarette use per day	week 1

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); APT Foundation, Inc.
• Investigators: Principal Investigator: Deepa R Camenga, MD, Yale University

Publications and helpful links

General Publications

• Camenga DR, Haeny AM, Krishnan-Sarin S, O'Malley SS, Bold KW. Pilot Ecological Momentary Assessment Study of Subjective and Contextual Factors Surrounding E-Cigarette and Combustible Tobacco Product Use among Young Adults. Int J Environ Res Public Health. 2021 Oct 20;18(21):11005. doi: 10.3390/ijerph182111005.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2018
• Primary Completion (Actual): October 17, 2018
• Study Completion (Actual): October 17, 2018

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1612018726; 1P50DA036151-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No