Alcohol; Harmful UseNCT04263259
Efficacy and Mechanisms of Mobile-Delivered Alcohol Attentional Bias Modification
A study testing Attentional Bias Modification in people with Alcohol; Harmful Use, run by University of New Mexico at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Alcohol; Harmful Use
- What is being tested?
- Attentional Bias Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jan 2020to 14 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Alcohol Use Disorders Identification Test greater than or equal to 8
- right-handed
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center on Alcoholism, Substance Abuse, & Addictions
Albuquerque, New Mexico, 87106
Mind Research Network
Albuquerque, New Mexico, 87106
About this study
This study evaluates the efficacy as well as psychological and neurobiological mechanisms of mobile-delivered alcohol attentional bias modification among heavy drinking adults.
Read the 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).
- Conditions
- Alcohol; Harmful Use
- Being tested
- Attentional Bias Modification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attentional Bias ModificationBehavioural
Also called Cognitive Retraining
Mobile-Delivered Cognitive Retraining Intervention
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Use Frequency
Number of days of alcohol use during the 4-week ecological momentary assessment period
Measured: 4 weeks
Alcohol Use Quantity
Number of standard drinks per day during the 4-week ecological momentary assessment period
Measured: 4 weeks
Negative Alcohol-Related Consequences
Number negative consequences experienced 4-week ecological momentary assessment period
Measured: 4 weeks
Secondary outcomes (2)
Attentional Bias to Alcohol
Measured with the Alcohol Dot Probe Task
Measured: 4 weeks
Alcohol Cue-Induced Neural Reward Circuit Activation
Regions of interest include ventral tegmental area, dorsal and ventral striatum
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start8 Jan 2020
- Primary completion14 Aug 2021
- Study completion14 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol; Harmful UseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263259
- Sponsor's protocol ID
- 13419
- Other IDs
- K01AA023233
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2020
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanisms of Mobile-Delivered Alcohol Attentional Bias Modification
- ClinicalTrials.gov ID
- NCT04263259
- Acronym / sponsor ID
- 13419
- Conditions
- Alcohol; Harmful Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 14 Aug 2021 (actual)
- Study completion
- 14 Aug 2021 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy as well as psychological and neurobiological mechanisms of mobile-delivered alcohol attentional bias modification among heavy drinking adults.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attentional Bias Modification | Experimental | Behavioral: Attentional Bias ModificationParticipants 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). |
| 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). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Alcohol Use Disorders Identification Test greater than or equal to 8
- right-handed
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Attentional Bias ModificationAlso: Cognitive RetrainingMobile-Delivered Cognitive Retraining Intervention | Behavioural | Attentional Bias Modification |
Primary outcome
Alcohol Use Frequency
Time frame: 4 weeks
Number of days of alcohol use during the 4-week ecological momentary assessment period
Alcohol Use Quantity
Time frame: 4 weeks
Number of standard drinks per day during the 4-week ecological momentary assessment period
Negative Alcohol-Related Consequences
Time frame: 4 weeks
Number negative consequences experienced 4-week ecological momentary assessment period
2 secondary outcomes
Attentional Bias to Alcohol
Time frame: 4 weeks
Alcohol Cue-Induced Neural Reward Circuit Activation
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attentional Bias Modification in people with Alcohol; Harmful Use, run by University of New Mexico at 2 sites 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 4 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: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Alcohol Use Frequency (time frame: 4 weeks). 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 18 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.