Attentional Bias Modification Training for E-cigarette Users

Study Overview
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Brief Summary
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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.

Official Title
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Attentional Bias Modification Training for E-cigarette Users

Conditions
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E-cigarette Use, Tobacco Use Cessation

Intervention / Treatment
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* Behavioral: Computerized attentional bias modification training
* Behavioral: Placebo attention control training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computerized attentional bias modification training<br> | Behavioral: Computerized attentional bias modification training<br>* 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.<br>|
| Placebo Comparator: Placebo attention control training<br> | Behavioral: Placebo attention control training<br>* 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<br>|

What is the study measuring?
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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 |