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Behavioural Intervention

Personalized VR Alcohol Approach Bias Modification (ApBM) Condition for Alcoholism (TABM Trial)

N/A

Waitlist Available

Led By David L Pennington

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must also be engaged in VA outpatient AUD treatment and express a desire to reduce, stop, or maintain cessation of alcohol use

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days post-randomization

Awards & highlights

TABM Trial Summary

This trial aims to study how a personalized cognitive training program can help Veterans with alcohol use disorder and a history of traumatic brain injury. The program aims to modify automatic responses to alcohol cues and reduce heavy drinking

Who is the study for?

This trial is for heavy drinking veterans who have mild to moderate traumatic brain injury (mmTBI) and alcohol use disorder (AUD). It aims to help them reduce harmful drinking behaviors, improve adherence to medical care, and promote healthier relationships.Check my eligibility

What is being tested?

The study tests a personalized cognitive training program using virtual reality (VR) designed to change the tendency of participants to automatically seek out alcohol. Participants will either receive this specialized VR training or a sham condition that does not target approach biases.See study design

What are the potential side effects?

Since the intervention involves behavioral therapy through VR, side effects may be minimal but could include discomfort with VR such as dizziness or nausea. Emotional responses due to content related to alcohol cues might also occur.

TABM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am currently in VA outpatient treatment for alcohol use and want to change my drinking habits.

TABM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent of Heavy Drinking Days

Secondary outcome measures

Cue-induced fMRI BOLD-signal craving activation contrasts

Other outcome measures

Cognitive flexibility

TABM Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Personalized VR Alcohol Approach Bias Modification (ApBM) ConditionExperimental Treatment1 Intervention

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.

Group II: Sham ConditionPlacebo Group1 Intervention

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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,620 Previous Clinical Trials

3,316,225 Total Patients Enrolled

43 Trials studying Alcoholism

6,418 Patients Enrolled for Alcoholism

David L PenningtonPrincipal InvestigatorSan Francisco VA Medical Center, San Francisco, CA

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the investigation open to participants aged 55 years and older?

"To be considered for participation in this study, individuals must be at least 18 years old but not exceed 65 years of age."

Answered by AI

Are there ongoing efforts to actively enroll patients in this research study?

"The clinical trial specified on clinicaltrials.gov is not presently open for enrollment. Although it was first listed on 7/1/2024 and last revised on 4/18/2024, there are currently 1401 alternative trials actively seeking participants."

Answered by AI

What are the potential risks associated with the Personalized Virtual Reality Alcohol Approach Bias Modification (ApBM) condition for individuals undergoing treatment?

"As this is a Phase 2 trial without established efficacy data but with some safety information available, the team at Power rated the safety of Personalized VR Alcohol Approach Bias Modification (ApBM) Condition as a 2 on a scale of 1 to 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Personalized Approach Bias Modification in Heavy Drinking Veterans With Mild to Moderate Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06380985.

All > Tbi > Traumatic Brain Injury