NCT04244032

Brief Summary

Alcohol use disorder is characterized by widespread neurocognitive impairments, however despite substantial advances in the intervention and treatment of alcohol use disorders, exceptionally few studies have been directed to improving these deficits. This project leverages computerized cognitive training, applied as an adjunct to inpatient treatment, to enhance neurocognitive recovery. This project informs public health and future intervention efforts by interrogating factors critical to intervention efficacy and clarifying relationships between neurocognitive recovery and treatment outcomes, including post-discharge alcohol consumption.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

January 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 28, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

2.4 years

First QC Date

January 22, 2020

Last Update Submit

December 9, 2024

Conditions

Alcohol Use Disorder

Keywords

Cognitive TrainingAlcohol Use Disorder

Outcome Measures

Primary Outcomes (3)

  • Working Memory

    Performance on neuropsychological measures indexing working memory capacity. Score range: 0-100 (scores \<40 are poor \[0-16th percentile\]; scores \>60 are good \[84th-100th percentile\]).

    Baseline and up to 3 weeks

  • Inhibitory Control

    Performance on neuropsychological measures indexing inhibitory control capacity. Score range: 0-100 (scores \<40 are poor \[0-16th percentile\]; scores \>60 are good \[84th-100th percentile\]).

    Baseline and up to 3 weeks

  • General Executive Function

    Performance on neuropsychological measures indexing general executive functioning. Score range: 0-100 (scores \<40 are poor \[0-16th percentile\]; scores \>60 are good \[84th-100th percentile\]).

    Baseline and up to 3 weeks

Study Arms (4)

Working Memory Training (WM)

EXPERIMENTAL

Participants complete training in a working memory task designed to utilize individually-adapted difficulty levels.

Behavioral: Working Memory Training

Inhibitory Control Training (IC)

EXPERIMENTAL

Participants complete training in an inhibitory control task designed to utilize individually-adapted difficulty levels.

Behavioral: Inhibitory Control Training

Bias Modification Training (BM)

ACTIVE COMPARATOR

Participants complete training in an active comparator task designed to weaken approach responses to alcohol-associated cues.

Behavioral: Bias Modification Training

Non-Trained control (NTC)

NO INTERVENTION

No active intervention is delivered beyond typical care.

Interventions

Working Memory TrainingBEHAVIORAL

Participants complete up to 12 sessions of computerized training (30-45 min each) in a working memory task designed to utilize individually-adapted difficulty levels.

Working Memory Training (WM)
Inhibitory Control TrainingBEHAVIORAL

Participants complete up to 12 sessions of computerized training (30-45 min each) in an inhibitory control task designed to utilize individually-adapted difficulty levels.

Inhibitory Control Training (IC)
Bias Modification TrainingBEHAVIORAL

Participants complete up to 12 sessions of computerized training (30-45 min each) in a bias modification task designed to utilize individually-adapted difficulty levels.

Bias Modification Training (BM)

Eligibility Criteria

Age25 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Minimum of 10 years of education
  • Meet DSM-5 criteria for alcohol use disorder

You may not qualify if:

  • Medical histories confounding interpretation regarding change in neuropsychological functioning (e.g., stroke)
  • Meet DSM-5 criteria for current/unremitted psychotic, panic, or bipolar disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Ben Lewis, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 28, 2020

Study Start

April 28, 2021

Primary Completion

September 22, 2023

Study Completion

September 15, 2024

Last Updated

December 13, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)