Efficacy and Mechanisms of Mobile-Delivered Alcohol Attentional Bias Modification

Sponsor

University of New Mexico (Other)

Overall Status

Unknown status

CT.gov ID

NCT04263259

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

Enrollment

Locations

Arms

3.2

Anticipated Duration (Months)

Patients Per Site

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alcohol; Harmful Use	Behavioral: Attentional Bias Modification	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Participants are not informed about the nature of the mobile-delivered intervention or their assignment to the intervention or control condition.

Primary Purpose:

Treatment

Official Title:

Efficacy and Mechanisms of Mobile-Delivered Alcohol Attentional Bias Modification

Actual Study Start Date :

Jan 8, 2020

Anticipated Primary Completion Date :

Apr 13, 2020

Anticipated Study Completion Date :

Apr 13, 2020

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center on Alcoholism, Substance Abuse, & Addictions	Albuquerque	New Mexico	United States	87106
2	Mind Research Network	Albuquerque	New Mexico	United States	87106

Sponsors and Collaborators

University of New Mexico
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of New Mexico

ClinicalTrials.gov Identifier:

NCT04263259

Other Study ID Numbers:

13419
K01AA023233

First Posted:

Feb 10, 2020

Last Update Posted:

Feb 10, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 10, 2020