Integration of Neurofunctional Phenotyping Into Investigation of CBT4CBT for AUD

Alcohol Use Disorder Clinical Trial

Official title: Integration of Neurofunctional Phenotyping Into a Preliminary Investigation of Stand-alone Web-based Cognitive Behavioral Therapy (CBT4CBT) for Alcohol Use Disorder

Status Recruiting

Clinical Trial Summary

Alcohol use and misuse are prevalent in the United States. Alcohol use disorder (AUD) is the most common substance use disorder. Evidence-based treatments are effective; however, most people with AUD do not receive treatment, and among those who do, responses to treatment modalities vary. Technology provides the opportunity to expand treatment and improve outcomes. Therefore, the overall goal of this project is to incorporate neurofunctional phenotyping into a preliminary investigation of the feasibility of providing mobile CBT4CBT for AUD among a non-treatment seeking population

Clinical Trial Description

Nationally, alcohol is the third leading preventable cause of death. In 2019, 14.1 million adults had an alcohol use disorder (AUD). However, most people with AUD do not receive treatment, and treatments are only moderately effective among those who do receive treatment largely due to the heterogeneity of people with AUD. Precision medicine is a method to guide tailoring individual treatment regimens and improve outcomes in evidence-based treatments. Recently, neurofunctional phenotyping approaches have emerged as a promising avenue to advance precision medicine in AUD. For example, studies of the Addictions Neuroclinical Assessment (ANA) framework-a neuroscience-based framework that uses three neurofunctional domains that are considered critical to the development and maintenance of AUD-suggest there are associations between ANA domains and drinking behavior. However, the utility of phenotyping approaches has not been investigated in behavioral treatment modalities for AUD. Additionally, although AUD is the most common substance use disorder (SUD), fewer people in need of AUD treatment receive it compared to treatment for other use disorders. Many of these individuals, particularly those with mild AUD, can reduce or cease alcohol use without specialized treatment. However, efforts to refer those with more severe AUD to community residential or outpatient programs have been largely unsuccessful, especially among women who often face practical barriers like lack of transportation and childcare. Technology offers innovative opportunities to make treatment more readily accessible to those in need. Computer-Based Training for Cognitive Behavioral Therapy (CBT4CBT) is a web-based intervention with demonstrated effectiveness as an adjunct to standard AUD and other drug use disorder treatment programming. To-date, however, it has not been tested with non-treatment seeking men and women with AUD. For the proposed study, a sample of non-treatment seeking people with AUD will be recruited using ResearchMatch.org and randomized (3:1) to complete the mobile CBT4CBT program or an assessment only control condition stratified by sex (N=248 total; females: n=93 CBT4CBT, n=31 Control; males: n=93 CBT4CBT, n=31 Control). Feasibility and acceptability of CBT4CBT will be assessed among participants in the CBT4CBT condition. Study assessments that include self-reported AUD outcomes and neurofunctional assessments will be administered to all participants at baseline, immediately post-intervention, and at one month following the intervention period. All outcomes will also be assessed for sex differences using sex-stratified analyses. ;

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

• NCT number: NCT06190236
• Study type: Interventional
• Source: Virginia Commonwealth University
• Contact: Dace Svikis
• Phone: (804) 827-1184
• Email: dssvikis@vcu.edu
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2024
• Completion date: December 2024