Attentional Bias Modification Training for E-cigarette Users

NCT05112562 | Unknown

• 1 other identifier: 20.172
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

E-cigarette Use; Tobacco Use Cessation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Subjective urges for e-cigarette use

  Pre-training

• Nicotine dependence

  Pre-training

• Subjective urges for e-cigarette use

  1-momnth follow up

• Nicotine dependence

  1-month follow up

• Subjective urges for e-cigarette use

  2-momnth follow up

Study Arms (2)

Computerized attentional bias modification training

EXPERIMENTAL

Behavioral: Computerized attentional bias modification training

Placebo attention control training

PLACEBO COMPARATOR

Behavioral: Placebo attention control training

Interventions

Computerized attentional bias modification training BEHAVIORAL

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.

Computerized attentional bias modification training

Placebo attention control training BEHAVIORAL

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

Placebo attention control training

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead

Study Sites (1)

University of Wisconsin-Milwaukee

Milwaukee, Wisconsin, 53211, United States

RECRUITING

MeSH Terms

Conditions

Vaping; Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Smoking; Behavior; Health Behavior

Study Officials

• Seok Hyun Gwon, PhD, RN

  University of Wisconsin, Milwaukee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seok Hyun Gwon, PhD, RN

CONTACT

414-229-6462; gwon@uwm.edu

Han Joo Lee, PhD

CONTACT

leehj@uwm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: November 9, 2021
• Study Start: June 9, 2021
• Primary Completion: May 31, 2023
• Study Completion: December 31, 2024
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)