Personalized Approach Bias Modification in Heavy Drinking Veterans With Mild to Moderate Traumatic Brain Injury

NCT06380985 | Withdrawn DMC

• 2 other identifiers: NURA-009-23F1I01CX002715-01A1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Alcohol Use Disorder; Mild-Moderate Traumatic Brain Injury

Keywords

Cognitive Bias Modification; Alcohol Use Disorder; Brain Injury, Traumatic; Alcohol-Related Disorders; Mental Disorders; Cognitive Training

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days post-randomization

Secondary Outcomes (1)

• Cue-induced fMRI BOLD-signal craving activation contrasts

  Week 4 - The week following completion of cognitive training.

Other Outcomes (1)

• Cognitive flexibility

  Week 4 - The week following completion of cognitive training.

Study Arms (2)

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.

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.

Behavioral: Sham Condition

Interventions

Personalized VR Alcohol Approach Bias Modification (ApBM) Condition BEHAVIORAL

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).

Also known as: ApBM Training

Personalized VR Alcohol Approach Bias Modification (ApBM) Condition

Sham Condition BEHAVIORAL

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.

Also known as: Sham Training

Sham Condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121-1563, United States

Location

MeSH Terms

Conditions

Alcoholism; Brain Injuries, Traumatic; Alcohol-Related Disorders; Mental Disorders

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• David L Pennington

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The identity of ApBM and Sham will not be known to investigators or patients. To maintain the blind, the participant and the research coordinator (naïve to ApBM) administering the participant's training will be blind to whether "1" or "2" is ApBM or Sham. The research coordinator will receive the patient assignment from statistical software at time of randomization. The key that determines assignment of ApBM or Sham to condition "1" or "2" will be known by an addiction research program affiliate PI otherwise uninvolved in the current study. They will document this key in a locked electronic file. The study blind will be broken on completion of the study and after the study database has been locked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This will be a Phase II double-blind, randomized, sham-controlled clinical trial.

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 24, 2024
• Study Start: June 24, 2024
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)