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
• 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
• 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

Related Conditions & MeSH terms

• Alcohol; Harmful Use

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