Attentional Bias Modification Training for E-cigarette Users

• Sponsor: University of Wisconsin, Milwaukee (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05112562
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 18.7
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
E-cigarette Use; Tobacco Use Cessation	Behavioral: Computerized attentional bias modification training; Behavioral: Placebo attention control training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Attentional Bias Modification Training for E-cigarette Users
• Actual Study Start Date: Jun 9, 2021
• Anticipated Primary Completion Date: May 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Attentional bias to e-cigarette cues [Pre-training]

   Attentional bias measured by a cueing task, dot-probe task, and/or eye-tracking task

2. Attentional bias to e-cigarette cues [1-month follow up]

   Attentional bias measured by a cueing task, dot-probe task, and/or eye-tracking task

3. Attentional bias to e-cigarette cues [2-months follow up]

   Attentional bias measured by a cueing task, dot-probe task, and/or eye-tracking task

4. Attentional bias to e-cigarette cues [4-months follow up]

   Attentional bias measured by a cueing task, dot-probe task, and/or eye-tracking task

Secondary Outcome Measures

1. Arousal/urges for e-cigarette use [Pre-training]

   Electrodermal reactivity (measured by a skin response sensor)

2. Arousal/urges for e-cigarette use [Pre-training]

   Heartrate variability (measured by a EKG recording device)

3. Arousal/urges for e-cigarette use [Pre-training]

   Subjective urges for ENDS use (measured by E-cigarette Use Patterns questionnaire)

4. Arousal/urges for e-cigarette use [Pre-training]

   Penn State E-Cigarette Dependence Index

5. Arousal/urges for e-cigarette use [1-month follow up]

   Electrodermal reactivity (measured by a skin response sensor)

6. Arousal/urges for e-cigarette use [1-month follow up]

   Heartrate variability (measured by a EKG recording device)

7. Arousal/urges for e-cigarette use [1-month follow up]

   Subjective urges for ENDS use (measured by E-cigarette Use Patterns questionnaire)

8. Arousal/urges for e-cigarette use [1-month follow up]

   Penn State E-Cigarette Dependence Index

9. Arousal/urges for e-cigarette use [2-month follow up]

   Electrodermal reactivity (measured by a skin response sensor)

10. Arousal/urges for e-cigarette use [2-month follow up]

    Heartrate variability (measured by a EKG recording device)

11. Arousal/urges for e-cigarette use [2-month follow up]

    Subjective urges for ENDS use (measured by E-cigarette Use Patterns questionnaire)

12. Arousal/urges for e-cigarette use [2-month follow up]

    Penn State E-Cigarette Dependence Index

13. Arousal/urges for e-cigarette use [4-month follow up]

    Electrodermal reactivity (measured by a skin response sensor)

14. Arousal/urges for e-cigarette use [4-month follow up]

    Heartrate variability (measured by a EKG recording device)

15. Arousal/urges for e-cigarette use [4-month follow up]

    Subjective urges for ENDS use (measured by E-cigarette Use Patterns questionnaire)

16. Arousal/urges for e-cigarette use [4-month follow up]

    Penn State E-Cigarette Dependence Index

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 29 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin-Milwaukee	Milwaukee	Wisconsin	United States	53211

Sponsors and Collaborators

• University of Wisconsin, Milwaukee

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Milwaukee
• ClinicalTrials.gov Identifier: NCT05112562
• Other Study ID Numbers: 20.172
• First Posted: Nov 9, 2021
• Last Update Posted: Nov 9, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 9, 2021