NCT03089541

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

February 16, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2018

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

May 3, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

March 20, 2017

Results QC Date

November 22, 2022

Last Update Submit

April 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Survey Arm

EXPERIMENTAL

Will receive incentives for completing surveys and evidence of tobacco use status daily for 1 week

Behavioral: Survey Arm

Interventions

Survey ArmBEHAVIORAL

Contingency Management for completion of surveys and evidence of tobacco use status

Survey Arm

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cigarette SmokingTobacco Use

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehavior

Limitations and Caveats

Small sample

Results Point of Contact

Title
Dr. Deepa Camenga, Principal Investigator
Organization
Yale School of Medicine

Study Officials

  • Deepa R Camenga, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 30 non-treatment seeking young adult e-cigarette/cigarette dual users (15 males/15 females) will participate in a contingency-management reinforced 1 week observation period
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 24, 2017

Study Start

February 16, 2018

Primary Completion

October 17, 2018

Study Completion

October 17, 2018

Last Updated

May 3, 2023

Results First Posted

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations