Attentional Bias Modification Training for E-cigarette Users

Aims are to (1) evaluate attentional bias to e-cigarette cues between the intervention and control groups at post-intervention as compared to the pre-intervention; and (2) test the feasibility and efficacy of the intervention at post-intervention. To accomplish these aims, a theory-driven parallel, controlled 2-arm randomized clinical trial will be conducted with young adult e-cigarette users (approximately N = 50). Outcomes are attentional bias to e-cigarette cues and abstinence outcomes including nicotine dependence, and arousal/urges for e-cigarette use.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Use Cessation; E-cigarette Use
• Intervention / Treatment: Behavioral: Computerized attentional bias modification training; Behavioral: Placebo attention control training

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seok Hyun Gwon, PhD, RN; Phone Number: 414-229-6462; Email: gwon@uwm.edu
• Study Contact Backup: Name: Han Joo Lee, PhD; Email: leehj@uwm.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53211
      • Recruiting
      • University of Wisconsin-Milwaukee
      • Contact: Seok Hyun Gwon, PhD, RN; Phone Number: 414-229-6462; Email: gwon@uwm.edu
      • Contact: Han Joo Lee, PhD; Email: leehj@uwm.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 18 and 29 years
• Those who use ENDS exclusively, not combining with other tobacco, for 3 consecutive months
• Those who own a smartphone.

Exclusion criteria:

• Current medication or psychosocial treatment for ENDS dependence
• Serious alcohol-use problems (≥ 26 points on the Alcohol Use Disorders Identification Test)
• Ophthalmic conditions impeding eye-tracking
• Current psychiatric/psychosocial treatment for other mental health disorders in the DSM-5 (e.g., schizophrenia)
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computerized attentional bias modification training	Behavioral: Computerized attentional bias modification training; In intervention is designed to train participants to disengage attention from potent e-cigarette cues and is based on the well-established attention retraining paradigm for other psychopathologies.
Placebo Comparator: Placebo attention control training	Behavioral: Placebo attention control training; This control training is very similar to the intervention's overall task structure and stimuli. The only difference is that the this control program is designed to exert no systematic manipulation on the attention deployment pattern between the two stimulus categories, thereby yielding no significant impact on the level of attentional bas toward ENDS-related cues

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attentional bias to e-cigarette cues measured by cueing task	Attentional bias measured by time in milliseconds between cue and response in cueing task	Pre-training
Attentional bias to e-cigarette cues measured by cueing task	Attentional bias measured by time in milliseconds between cue and response in cueing task	1-month follow up
Attentional bias to e-cigarette cues measured by cueing task	Attentional bias measured by time in milliseconds between cue and response in cueing task	2-months follow up
Attentional bias to e-cigarette cues measured by cueing task	Attentional bias measured by time in milliseconds between cue and response in cueing task	4-months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective urges for e-cigarette use	Subjective urges for ENDS use measured by E-cigarette Use Patterns questionnaire)	Pre-training
Nicotine dependence	Nicotine dependence measured by Penn State E-Cigarette Dependence Index	Pre-training
Subjective urges for e-cigarette use	Subjective urges for ENDS use measured by E-cigarette Use Patterns questionnaire)	1-momnth follow up
Nicotine dependence	Nicotine dependence measured by Penn State E-Cigarette Dependence Index	1-month follow up
Subjective urges for e-cigarette use	Subjective urges for ENDS use measured by E-cigarette Use Patterns questionnaire)	2-momnth follow up
Nicotine dependence	Nicotine dependence measured by Penn State E-Cigarette Dependence Index	2-month follow up
Subjective urges for e-cigarette use	Subjective urges for ENDS use measured by E-cigarette Use Patterns questionnaire)	4-momnth follow up
Nicotine dependence	Nicotine dependence measured by Penn State E-Cigarette Dependence Index	4-month follow up

Collaborators and Investigators

• Sponsor: University of Wisconsin, Milwaukee
• Investigators: Principal Investigator: Seok Hyun Gwon, PhD, RN, University of Wisconsin, Milwaukee

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2021
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 20.172

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