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NCT04263259 Clinical Trial

Efficacy and Mechanisms of Mobile-Delivered Alcohol Attentional Bias Modification

Alcohol; Harmful Use Clinical Trial

Official title:
Efficacy and Mechanisms of Mobile-Delivered Alcohol Attentional Bias Modification

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04263259
Other study ID # 13419
Secondary ID K01AA023233
Status Completed
Phase N/A
First received
Last updated
Start date January 8, 2020
Est. completion date August 14, 2021

Study information
Verified date February 2020
Source University of New Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date August 14, 2021
Est. primary completion date August 14, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Attentional Bias Modification
Mobile-Delivered Cognitive Retraining Intervention

Locations
Country Name City State
United States Center on Alcoholism, Substance Abuse, & Addictions Albuquerque New Mexico
United States Mind Research Network Albuquerque New Mexico

Sponsors (2)
Lead Sponsor Collaborator
University of New Mexico National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Alcohol Use Frequency Number of days of alcohol use during the 4-week ecological momentary assessment period 4 weeks
Primary Alcohol Use Quantity Number of standard drinks per day during the 4-week ecological momentary assessment period 4 weeks
Primary Negative Alcohol-Related Consequences Number negative consequences experienced 4-week ecological momentary assessment period 4 weeks
Secondary Attentional Bias to Alcohol Measured with the Alcohol Dot Probe Task 4 weeks
Secondary Alcohol Cue-Induced Neural Reward Circuit Activation Regions of interest include ventral tegmental area, dorsal and ventral striatum 4 weeks
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