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Terminated NCT04430543

Neural and Behavioral Effects of Cognitive Bias Modification (CBM)

Conditions: Alcohol Drinking

Sex: All
Ages: 18 Years – 34 Years
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: Boston University Charles River Campus

Location: Rajen Kilachand Center for Integrated Life Sciences and Engineering at Boston University Boston Massachusetts

Summary

This study seeks to better understand mechanisms of behavior change for heavy drinkers who are interested in changing their drinking. The study will examine the effects of CBM as an adjunctive treatment on neurocognitive processes related to alcohol use in a sample of heavy/at-risk drinkers using functional magnetic resonance imaging (fMRI). The primary aim of this project is to examine the effects of CBM on neurocognitive approach tendencies and control processes, among heavy/at-risk drinkers interested in changing their alcohol use. As a secondary aim, this project will investigate associations between neural and cognitive changes and changes in alcohol use to better understand how CBM might lead to successful changes in drinking behavior. Either CBM (treatment group) or sham computer task (control group) will be paired with a motivational web-based intervention for alcohol use. Brain activity will be measures twice via fMRI--pre-treatment and 1-week post-treatment. The experimental tasks completed in the fMRI scans include 2 alcohol cue reactivity (CR) tasks--one standard and one in which participants are told to either inhibit (INHIBIT) or engage in (INDULGE) their reaction to images of alcohol and neutral beverages. Follow-up drinking behavior will be measured also at 1-week and online via 1- and 6-month follow-ups. Brain activity at baseline and follow-up will be measured in pre-defined regions of interest including amygdala, NAcc, mPFC, and dlPFC. It is hypothesized that the CBM group will exhibit changes in approach biases as exhibited by reductions in brain activity in the amygdala, NAcc, mPFC in response to alcohol cues in both CR tasks (alcohol CR, INDULGE CR, and INHIBIT CR) compared to sham. In addition, those in the CBM group will show increased dlPFC brain activity during alcohol CR and INHIBIT trials of the cued-CR task as evidence strengthened control abilities in response to alcohol cues. Finally, as a secondary hypothesis, those in the CBM group will show greater reductions in drinking and craving at follow-up.

Eligibility Criteria

Inclusion Criteria: * current hazardous drinking (score of 8+ on USAUDIT-C) * interest in changing drinking * English-speaking * able to provide informed consent Exclusion Criteria: * Score of 25+ on USAUDIT * current or past treatment for alcohol or drug use * lifetime diagnosis of other substance use disorder * self-reported weekly or more other drug use as indicated on the NIDA-modified Alcohol, Smoking, and Substance Involvement Screening Test * history of head injury or loss of consciousness * lifetime diagnosis of bipolar disorder, psychotic symptomatology, organic mental disorder, seizure disorder, or central nervous system disease * pregnancy * current use of psychotropic medication * history of delirium tremens and/or seizures as a result of alcohol withdrawal * contraindications to fMRI (claustrophobia, pregnancy, metal, pacemaker, etc.).

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04430543). StuddyBuddy aggregates publicly available trial information.