Efficacy and Mechanisms of Mobile-Delivered Alcohol Attentional Bias Modification

This study evaluates the efficacy as well as psychological and neurobiological mechanisms of mobile-delivered alcohol attentional bias modification among heavy drinking adults.

Study Overview

• Status: Completed
• Conditions: Alcohol; Harmful Use
• Intervention / Treatment: Behavioral: Attentional Bias Modification

Detailed Description

By testing the efficacy and neurobiological mechanisms of behavior change (MOBC) following attentional bias modification among heavy drinking adults, the proposed study has the potential to unify dual process models and neurobiological models of addiction. The cognitive retraining will be delivered via mobile electronic devices to ensure the cost-effectiveness of these procedures, to allow a large amount of retraining to be delivered in an ecologically valid manner, and to facilitate broad dissemination of such procedures if found to be efficacious. Using an intensive longitudinal experimental design, subjects will be randomly assigned into one of 2 groups (attentional bias modification vs. attentional bias control). Ecological momentary assessment (EMA) data will be used to assess changes in cognitive and behavioral measures in situ, and functional magnetic resonance imaging (fMRI) scans before and after cognitive retraining will be used to examine neural changes in specific regions of interest (ROI).

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew R Pearson, Ph.D.; Phone Number: 5059252322; Email: mateo.pearson@gmail.com

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Mind Research Network
    • Albuquerque, New Mexico, United States, 87106
      • Center on Alcoholism, Substance Abuse, & Addictions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Alcohol Use Disorders Identification Test greater than or equal to 8
• right-handed

Exclusion Criteria:

• history of treatment for or diagnosis of alcohol use disorder/substance use disorder
• history of brain injury
• for females, currently pregnant
• any MRI safety contraindication

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: Attentional Bias Modification; Participants complete attentional bias modification using a dot probe task on a mobile device up to 5 times per day for a 28-day period (80 trials per assessment).	Behavioral: Attentional Bias Modification; Mobile-Delivered Cognitive Retraining Intervention; Other Names: Cognitive Retraining
No Intervention: Attentional Bias Control; Participants complete attentional bias assessment-only using a dot probe task on a mobile device up to 5 times per day for a 28-day period (80 trials per assessment).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Use Frequency	Number of days of alcohol use during the 4-week ecological momentary assessment period	4 weeks
Alcohol Use Quantity	Number of standard drinks per day during the 4-week ecological momentary assessment period	4 weeks
Negative Alcohol-Related Consequences	Number negative consequences experienced 4-week ecological momentary assessment period	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attentional Bias to Alcohol	Measured with the Alcohol Dot Probe Task	4 weeks
Alcohol Cue-Induced Neural Reward Circuit Activation	Regions of interest include ventral tegmental area, dorsal and ventral striatum	4 weeks

Collaborators and Investigators

• Sponsor: University of New Mexico
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2020
• Primary Completion (Actual): August 14, 2021
• Study Completion (Actual): August 14, 2021

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 13419 (Company internal); K01AA023233 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be shared with other researchers.
• IPD Sharing Time Frame: Data can be requested from the PI by October 2020
• IPD Sharing Access Criteria: Data will be shared with qualified scientists who enter a data sharing usage agreement

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No