Alcohol Use DisorderTABMNCT06380985
Personalized Approach Bias Modification in Heavy Drinking Veterans With Mild to Moderate Traumatic Brain Injury
A study testing Personalized VR Alcohol Approach Bias Modification (ApBM) Condition in people with Alcohol Use Disorder and Mild-Moderate Traumatic Brain Injury, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The project will examine the neural associations of alcohol approach-bias and investigate the extent to which a neuroscience-based personalized cognitive training program will remediate alcohol approach-bias and improve recovery outcomes among heavy drinking Veterans with alcohol use disorder (AUD) and a history of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder, Mild-Moderate Traumatic Brain Injury
- What is being tested?
- Personalized VR Alcohol Approach Bias Modification (ApBM) Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2024to 24 Jun 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A history of mild-moderate TBI, as defined by American Congress of Rehabilitation Medicine (ACRM), in the chronic, stable phase of recovery (>6 months from injury)
- Heavy drinking defined by NIH/NIAAA criteria (>7 drinks/week for women; >14 drinks/week for men) for at least one week in the last 90 days
- Moderate to severe criteria for current alcohol use disorder (AUD) by DSM-5
- Participants must also be engaged in VA outpatient AUD treatment and express a desire to reduce, stop, or maintain cessation of alcohol use
Who cannot join
- Unstable clinically significant psychiatric disorders or medical conditions that would create excessive risks, in the clinical judgment of the Principle Investigator
- Current or history of the following:
- intrinsic cerebral tumors
- demyelinating and neurodegenerative diseases
- aneurysm
- arteriovenous malformations
Show all 17Show fewer
- cerebrovascular or peripheral vascular disease
- severe or penetrating traumatic brain injury
- documented learning disabilities
- surgical implantation of neurostimulators or cardiac pacemakers and any other MRI contraindications
- These conditions/diseases are known to influence the neurocognitive and MR-derived neurobiological measures proposed in this application
- Female participant who is pregnant or actively attempting to conceive (to prevent any unnecessary exposure to high magnetic fields or radiofrequency energy to the unborn child)
- Concurrent participation in another clinical trial on AUD or TBI study
- Requiring acute medical detoxification from alcohol, based on a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD)
- Legal mandate to participate in an alcohol treatment program
- Presence of severe TBI or penetrating head trauma
- Starting use of AUD treatment medications (disulfiram, naltrexone, or acamprosate) within the past 4 weeks (must be on AUD treatment for longer than 4 weeks)
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563
About this study
Official title: Personalized Approach Bias Modification to Reduce Heavy Drinking and Improve Cognitive Control in Veterans With Mild to Moderate Traumatic Brain Injury
The project will examine the neural associations of alcohol approach-bias and investigate the extent to which a neuroscience-based personalized cognitive training program will remediate alcohol approach-bias and improve recovery outcomes among heavy drinking Veterans with alcohol use disorder (AUD) and a history of mild-moderate traumatic brain injury (mmTBI). Alcohol approach-bias modification (ApBM) is a cognitive training intervention designed to interrupt and modify automatic approach processes in response to alcohol cues. Modification of alcohol approach-bias and reductions in heavy alcohol use can be expected to reduce behaviors of self-harm and violence, increase adherence to medical care, reduce drinking-related medical costs, and promote healthier relationships. The long-term goal is to demonstrate the efficacy of ApBM to promote recovery from AUD in Veterans with chronic mmTBI. The investigators also aim to identify neural mechanisms associated with ApBM and other neurocognitive predictors of successful recovery. The evidence garnered from this study will be useful to inform the development of other behavioral and pharmacological treatments for Veterans with AUD with a history of mmTBI.
Read the detailed description
This study is the first to test if Alcohol approach-bias modification (ApBM), delivered through virtual reality, as an add-on to outpatient treatment can reduce heavy alcohol use and improve neuro-cognitive outcomes among Veterans with mild to moderate traumatic brain injury (mmTBI) engaged in outpatient treatment for alcohol use disorder (AUD).
This will be a Phase II double-blind, randomized, sham-controlled clinical trial. Approximately 100 heavy drinking Veterans with alcohol use disorder (AUD) and a history of mild to moderate traumatic brain injury (mmTBI) will be randomized into the study to complete a 3-week of either personalized ApBM or sham training (9 training sessions). Immediately following the 3-week training, a post-intervention Week-4 assessment will be administered. The participants will also be re-assessed again at Week 12 as the last study visit.
The aims of the study are as follows:
Aim 1: Establish the efficacy of a personalized alcohol ApBM to promote recovery from AUD among heavy drinking Veterans with a history of mmTBI.
Aim 2: Evaluate alcohol ApBM related change in fMRI cue-induced craving outcomes of treatment response within Default Mode Network.
Aim 3: Assess alcohol approach bias modification-related improvement in cognitive executive functioning domains that typically show deficit in heavy drinking Veterans with mmTBI and replicate preliminary associations between executive function domains and alcohol approach bias.
- Being tested
- Personalized VR Alcohol Approach Bias Modification (ApBM) Condition, Sham Condition
- Keywords
- Cognitive Bias Modification, Alcohol Use Disorder, Brain Injury, Traumatic, Alcohol-Related Disorders, Mental Disorders, Cognitive Training
- Medical subject headings
- Alcoholism, Brain Injuries, Traumatic, Alcohol-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized VR Alcohol Approach Bias Modification (ApBM) ConditionBehavioural
Also called ApBM Training
The Personalized VR ApBM will consist of 2D pictures representing alcohol or positive images (e.g., representing family or friends enjoying time together; sports, pets; travel and holidays, etc.) presented in a unique format in VR (e.g., landscape/portrait orientation), which will serve as the cue requiring a stimulus response. Participants are instructed to push the images away from them if they are presented in one format (e.g., landscape) and grab (using lever on VR controller) the images and pull towards themselves in response to a separate format (e.g., portrait pictures) across a virtual table. Each training session starts with 10 practice trials showing neutral objects (containers), followed by 240 training trials (120 alcohol and 120 non-alcohol trials). Training effect is achieved by altering the contingency of push vs. pull by image type (alcohol vs. positive).
Sham ConditionBehavioural
Also called Sham Training
Sham training is identical to ApBM, except the contingency of each orientation (e.g., portrait or landscape) representing a push vs. a pull is altered to diminish training effect.
| Study group | Role | What they receive |
|---|---|---|
| Personalized VR Alcohol Approach Bias Modification (ApBM) Condition | Experimental | The Personalized VR ApBM will consist of 9 cognitive training sessions, each session lasting approximately 20 minutes completed on separate days over 3 weeks. Each session requires the participant to respond to 240 visual stimuli using a push or pull motion as quickly as possible. Receives: Behavioral: Personalized VR Alcohol Approach Bias Modification (ApBM) Condition |
| Sham Condition | Sham comparator | Sham training will consist of 9 cognitive training sessions, each session lasting approximately 20 minutes completed on separate days over 3 weeks. Each session requires the participant to respond to 240 visual stimuli using a push or pull motion as quickly as possible. Receives: Behavioral: Sham Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Heavy Drinking Days
The primary endpoint is percent of heavy drinking days during the 90 days post-randomization into treatment. A heavy drinking day is defined using NIH/NIAAA criteria, drinking more than 4 drinks a day for men and more than 3 drinks a single day for women.
Measured: 90 days post-randomization
Secondary outcomes (1)
Cue-induced fMRI BOLD-signal craving activation contrasts
BOLD-signal craving activation contrasts (alcohol cues > neutral cues) in amygdala, nucleus accumbens, and posterior cingulate cortex.
Measured: Week 4 - The week following completion of cognitive training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start24 Jun 2024
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Why it stopped: PI resigned from his VA position
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a Phase II double-blind, randomized, sham-controlled clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David L Pennington, Principal investigator, San Francisco VA Medical Center, San Francisco, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380985
- Sponsor's protocol ID
- NURA-009-23F
- Other IDs
- 1I01CX002715-01A1
- Acronym
- TABM
- Status last verified
- Jun 2024
- First submitted
- 18 Apr 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Approach Bias Modification to Reduce Heavy Drinking and Improve Cognitive Control in Veterans With Mild to Moderate Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06380985
- Acronym / sponsor ID
- TABM / NURA-009-23F
- Keywords
- Cognitive Bias Modification, Alcohol Use Disorder, Brain Injury, Traumatic, Alcohol-Related Disorders, Mental Disorders, Cognitive Training
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI resigned from his VA position
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 24 Apr 2024 (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.
The project will examine the neural associations of alcohol approach-bias and investigate the extent to which a neuroscience-based personalized cognitive training program will remediate alcohol approach-bias and improve recovery outcomes among heavy drinking Veterans with alcohol use disorder (AUD) and a history of mild-moderate traumatic brain injury (mmTBI). Alcohol approach-bias modification (ApBM) is a cognitive training intervention designed to interrupt and modify automatic approach processes in response to alcohol cues. Modification of alcohol approach-bias and reductions in heavy alcohol use can be expected to reduce behaviors of self-harm and violence, increase adherence to medical care, reduce drinking-related medical costs, and promote healthier relationships. The long-term goal is to demonstrate the efficacy of ApBM to promote recovery from AUD in Veterans with chronic mmTBI. The investigators also aim to identify neural mechanisms associated with ApBM and other neurocognitive predictors of successful recovery. The evidence garnered from this study will be useful to inform the development of other behavioral and pharmacological treatments for Veterans with AUD with a history of mmTBI.
Detailed description
This study is the first to test if Alcohol approach-bias modification (ApBM), delivered through virtual reality, as an add-on to outpatient treatment can reduce heavy alcohol use and improve neuro-cognitive outcomes among Veterans with mild to moderate traumatic brain injury (mmTBI) engaged in outpatient treatment for alcohol use disorder (AUD).
This will be a Phase II double-blind, randomized, sham-controlled clinical trial. Approximately 100 heavy drinking Veterans with alcohol use disorder (AUD) and a history of mild to moderate traumatic brain injury (mmTBI) will be randomized into the study to complete a 3-week of either personalized ApBM or sham training (9 training sessions). Immediately following the 3-week training, a post-intervention Week-4 assessment will be administered. The participants will also be re-assessed again at Week 12 as the last study visit.
The aims of the study are as follows:
Aim 1: Establish the efficacy of a personalized alcohol ApBM to promote recovery from AUD among heavy drinking Veterans with a history of mmTBI.
Aim 2: Evaluate alcohol ApBM related change in fMRI cue-induced craving outcomes of treatment response within Default Mode Network.
Aim 3: Assess alcohol approach bias modification-related improvement in cognitive executive functioning domains that typically show deficit in heavy drinking Veterans with mmTBI and replicate preliminary associations between executive function domains and alcohol approach bias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This will be a Phase II double-blind, randomized, sham-controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Personalized VR Alcohol Approach Bias Modification (ApBM) Condition | Experimental | Behavioral: Personalized VR Alcohol Approach Bias Modification (ApBM) ConditionThe Personalized VR ApBM will consist of 9 cognitive training sessions, each session lasting approximately 20 minutes completed on separate days over 3 weeks. Each session requires the participant to respond to 240 visual stimuli using a push or pull motion as quickly as possible. |
| Sham Condition | Sham comparator | Behavioral: Sham ConditionSham training will consist of 9 cognitive training sessions, each session lasting approximately 20 minutes completed on separate days over 3 weeks. Each session requires the participant to respond to 240 visual stimuli using a push or pull motion as quickly as possible. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A history of mild-moderate TBI, as defined by American Congress of Rehabilitation Medicine (ACRM), in the chronic, stable phase of recovery (>6 months from injury)
- Heavy drinking defined by NIH/NIAAA criteria (>7 drinks/week for women; >14 drinks/week for men) for at least one week in the last 90 days
- Moderate to severe criteria for current alcohol use disorder (AUD) by DSM-5
- Participants must also be engaged in VA outpatient AUD treatment and express a desire to reduce, stop, or maintain cessation of alcohol use
Key exclusion criteria (17 listed)
- Unstable clinically significant psychiatric disorders or medical conditions that would create excessive risks, in the clinical judgment of the Principle Investigator
- Current or history of the following:
- Female participant who is pregnant or actively attempting to conceive (to prevent any unnecessary exposure to high magnetic fields or radiofrequency energy to the unborn child)
- Concurrent participation in another clinical trial on AUD or TBI study
- Requiring acute medical detoxification from alcohol, based on a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD)
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 |
|---|---|---|
| Personalized VR Alcohol Approach Bias Modification (ApBM) ConditionAlso: ApBM TrainingThe Personalized VR ApBM will consist of 2D pictures representing alcohol or positive images (e.g., representing family or friends enjoying time together; sports, pets; travel and holidays, etc.) presented in a unique format in VR (e.g., landscape/portrait orientation), which will serve as the cue requiring a stimulus response. Participants are instructed to push the images away from them if they are presented in one format (e.g., landscape) and grab (using lever on VR controller) the images and pull towards themselves in response to a separate format (e.g., portrait pictures) across a virtual table. Each training session starts with 10 practice trials showing neutral objects (containers), followed by 240 training trials (120 alcohol and 120 non-alcohol trials). Training effect is achieved by altering the contingency of push vs. pull by image type (alcohol vs. positive). | Behavioural | Personalized VR Alcohol Approach Bias Modification (ApBM) Condition |
| Sham ConditionAlso: Sham TrainingSham training is identical to ApBM, except the contingency of each orientation (e.g., portrait or landscape) representing a push vs. a pull is altered to diminish training effect. | Behavioural | Sham Condition |
Primary outcome
Percent of Heavy Drinking Days
Time frame: 90 days post-randomization
The primary endpoint is percent of heavy drinking days during the 90 days post-randomization into treatment. A heavy drinking day is defined using NIH/NIAAA criteria, drinking more than 4 drinks a day for men and more than 3 drinks a single day for women.
1 secondary outcome
Cue-induced fMRI BOLD-signal craving activation contrasts
Time frame: Week 4 - The week following completion of cognitive training.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- 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.
David L Pennington principal investigator
San Francisco VA Medical Center, San Francisco, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized VR Alcohol Approach Bias Modification (ApBM) Condition in people with Alcohol Use Disorder and Mild-Moderate Traumatic Brain Injury, run by VA Office of Research and Development 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 4 inclusion and 17 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: withdrawn, as of the sponsor's last update on 27 Jun 2024. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Percent of Heavy Drinking Days (time frame: 90 days post-randomization). 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 27 Jun 2024.