Attentional Bias Modification Training for E-cigarette Users

Tobacco Use Cessation Clinical Trial

Official title:

Attentional Bias Modification Training for E-cigarette Users

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05112562
• Other study ID #: 20.172
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2022
• Source: University of Wisconsin, Milwaukee
• Contact: Seok Hyun Gwon, PhD, RN
• Phone: 414-229-6462
• Email: gwon[@]uwm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• E-cigarette Use
• Tobacco Use Cessation

Intervention

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 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

Locations

Country	Name	City	State
United States	University of Wisconsin-Milwaukee	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Milwaukee

Country where clinical trial is conducted

United States, 

Outcome

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