Alcohol Use DisorderNCT04244032
Cognitive Enhancement Through Computerized Training
A study testing Working Memory Training and Bias Modification Training in people with Alcohol Use Disorder, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 64 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Working Memory Training and Bias Modification Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2021to 15 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Minimum of 10 years of education
- Meet DSM-5 criteria for alcohol use disorder
Who cannot join
- Medical histories confounding interpretation regarding change in neuropsychological functioning (e.g., stroke)
- Meet DSM-5 criteria for current/unremitted psychotic, panic, or bipolar disorders
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Programmatic investigation of neurocognitive functioning in alcohol use disorder (AUD) has revealed widespread and sustained impairments. Despite conceptual relevance to treatment efficacy, few AUD interventions have been directed to the remediation of these impairments. This project is responsive to this gap. It will answer critical questions regarding the potential of cognitive training (CT), applied as an adjunct to inpatient treatment, to improve cognitive recovery and post-discharge functional outcomes in AUD.
The current project will investigate the efficacy of two experimental cognitive training interventions in a sample of inpatients in treatment for AUD. While the effectiveness of CT to enhance function is supported by diverse literatures, it remains largely unexamined in AUD. The current project will interrogate the degree to which cognitive training interventions can "transfer" cognitive gains to untrained tasks/domains, and improve overall executive functioning. It will apply conceptual models from the CT and alcohol literatures to identify factors associated with CT efficacy. The impact of cognitive training on functional outcomes, including post-discharge drinking, will be investigated. Finally, relationships between cognitive recovery during treatment and post-discharge adaptation will be examined. Thus, the current work will be of substantial import to public health, alcohol science, and will inform future intervention efforts.
- Conditions
- Alcohol Use Disorder
- Being tested
- Working Memory Training, Inhibitory Control Training, Bias Modification Training
- Keywords
- Cognitive Training, Alcohol Use Disorder
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working Memory TrainingBehavioural
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.
Inhibitory Control TrainingBehavioural
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.
Bias Modification TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Working Memory Training (WM) | Experimental | Participants complete training in a working memory task designed to utilize individually-adapted difficulty levels. Receives: Behavioral: Working Memory Training |
| Inhibitory Control Training (IC) | Experimental | Participants complete training in an inhibitory control task designed to utilize individually-adapted difficulty levels. Receives: 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. Receives: Behavioral: Bias Modification Training |
| Non-Trained control (NTC) | No intervention | No active intervention is delivered beyond typical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Working Memory Performance
Percent accuracy on neuropsychological measures indexing working memory capacity. Scores range from 0% to 100%, with higher percentages indicating better performance.
Measured: Baseline to Post-Test, Up to 3 months
Change in Inhibitory Control Performance
Response time, in seconds, on neuropsychological measures indexing inhibitory control capacity. Values represent the change in response time from baseline to follow-up.
Measured: Baseline to Post-Test, Up to 3 months
Change in General Executive Function Performance
Response time, in seconds, on neuropsychological measures indexing general executive functioning. Values represent the change in response time from baseline to follow-up.
Measured: Baseline to Post-Test, Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start28 Apr 2021
- Primary completion22 Sep 2023
- Study completion15 Sep 2024
Why it stopped: enrollment barriers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Ben Lewis, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244032
- Sponsor's protocol ID
- IRB201901330
- Other IDs
- K01AA026893
- Status last verified
- Dec 2024
- First submitted
- 22 Jan 2020
- Last updated
- 16 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Enhancement Through Computerized Training
- ClinicalTrials.gov ID
- NCT04244032
- Acronym / sponsor ID
- IRB201901330
- Conditions
- Alcohol Use Disorder
- Keywords
- Cognitive Training, Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment barriers
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Posted 16 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Programmatic investigation of neurocognitive functioning in alcohol use disorder (AUD) has revealed widespread and sustained impairments. Despite conceptual relevance to treatment efficacy, few AUD interventions have been directed to the remediation of these impairments. This project is responsive to this gap. It will answer critical questions regarding the potential of cognitive training (CT), applied as an adjunct to inpatient treatment, to improve cognitive recovery and post-discharge functional outcomes in AUD.
The current project will investigate the efficacy of two experimental cognitive training interventions in a sample of inpatients in treatment for AUD. While the effectiveness of CT to enhance function is supported by diverse literatures, it remains largely unexamined in AUD. The current project will interrogate the degree to which cognitive training interventions can "transfer" cognitive gains to untrained tasks/domains, and improve overall executive functioning. It will apply conceptual models from the CT and alcohol literatures to identify factors associated with CT efficacy. The impact of cognitive training on functional outcomes, including post-discharge drinking, will be investigated. Finally, relationships between cognitive recovery during treatment and post-discharge adaptation will be examined. Thus, the current work will be of substantial import to public health, alcohol science, and will inform future intervention efforts.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Working Memory Training (WM) | Experimental | Behavioral: Working Memory TrainingParticipants complete training in a working memory task designed to utilize individually-adapted difficulty levels. |
| Inhibitory Control Training (IC) | Experimental | Behavioral: Inhibitory Control TrainingParticipants complete training in an inhibitory control task designed to utilize individually-adapted difficulty levels. |
| Bias Modification Training (BM) | Active comparator | Behavioral: Bias Modification TrainingParticipants complete training in an active comparator task designed to weaken approach responses to alcohol-associated cues. |
| Non-Trained control (NTC) | No intervention | –No active intervention is delivered beyond typical care. |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Minimum of 10 years of education
- Meet DSM-5 criteria for alcohol use disorder
Key exclusion criteria (2 listed)
- Medical histories confounding interpretation regarding change in neuropsychological functioning (e.g., stroke)
- Meet DSM-5 criteria for current/unremitted psychotic, panic, or bipolar disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Working Memory TrainingParticipants complete up to 12 sessions of computerized training (30-45 min each) in a working memory task designed to utilize individually-adapted difficulty levels. | Behavioural | Working Memory Training (WM) |
| Inhibitory Control TrainingParticipants complete up to 12 sessions of computerized training (30-45 min each) in an inhibitory control task designed to utilize individually-adapted difficulty levels. | Behavioural | Inhibitory Control Training (IC) |
| Bias Modification TrainingParticipants complete up to 12 sessions of computerized training (30-45 min each) in a bias modification task designed to utilize individually-adapted difficulty levels. | Behavioural | Bias Modification Training (BM) |
Primary outcome
Change in Working Memory Performance
Time frame: Baseline to Post-Test, Up to 3 months
Percent accuracy on neuropsychological measures indexing working memory capacity. Scores range from 0% to 100%, with higher percentages indicating better performance.
Change in Inhibitory Control Performance
Time frame: Baseline to Post-Test, Up to 3 months
Response time, in seconds, on neuropsychological measures indexing inhibitory control capacity. Values represent the change in response time from baseline to follow-up.
Change in General Executive Function Performance
Time frame: Baseline to Post-Test, Up to 3 months
Response time, in seconds, on neuropsychological measures indexing general executive functioning. Values represent the change in response time from baseline to follow-up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Lewis, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Working Memory Training and Bias Modification Training in people with Alcohol Use Disorder, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Working Memory Performance (time frame: Baseline to Post-Test, Up to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.