NCT04263259

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2021

Completed
Last Updated

May 18, 2023

Status Verified

February 1, 2020

Enrollment Period

1.6 years

First QC Date

February 7, 2020

Last Update Submit

May 16, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Attentional Bias to Alcohol

    4 weeks

  • Alcohol Cue-Induced Neural Reward Circuit Activation

    4 weeks

Study Arms (2)

Attentional Bias Modification

EXPERIMENTAL

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

Attentional Bias Control

NO INTERVENTION

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).

Interventions

Mobile-Delivered Cognitive Retraining Intervention

Also known as: Cognitive Retraining
Attentional Bias Modification

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center on Alcoholism, Substance Abuse, & Addictions

Albuquerque, New Mexico, 87106, United States

Location

Mind Research Network

Albuquerque, New Mexico, 87106, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are not informed about the nature of the mobile-delivered intervention or their assignment to the intervention or control condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 10, 2020

Study Start

January 8, 2020

Primary Completion

August 14, 2021

Study Completion

August 14, 2021

Last Updated

May 18, 2023

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

De-identified data will be shared with other researchers.

Time Frame
Data can be requested from the PI by October 2020
Access Criteria
Data will be shared with qualified scientists who enter a data sharing usage agreement

Locations