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Clinical Trial Summary

The overarching goal of this project is to expand the traditional expertise in non-invasive neuromodulation at the University of Minnesota towards developing novel paired-neuromodulation approaches using transcranial direct current stimulation (tDCS) for new treatments for alcohol use disorder (AUD) that support long-term abstinence. This study will allow the investigators to discern whether the pairing of dorsolateral prefrontal cortex (DLPFC) stimulation and cognitive training can lead to improved treatment outcomes as it pertains to executive functioning and maintenance of abstinence. This paired-neuromodulation approach can potentially be used as a therapeutic intervention to decrease relapse probability in addiction. The long-term goal is to develop new addiction treatments that support long-term abstinence. Our exploratory goal is to associate genotypes and epigenetic changes with variations in intervention response and clinical outcome. Individual differences in baseline genetic profiles or epigenetic changes over the course of treatment could be associated with treatment response variability.

Clinical Trial Description

The relapsing nature of alcohol use disorder is a major obstacle to successful treatment. About 40% of those entering treatment will relapse within one year. To improve treatment outcome, new interventions targeting the underlying brain biomarkers of relapse vulnerability hold significant promise in reducing this critical public health problem. Executive functioning, the ability to change maladaptive behavior, depends on DLPFC input to nucleus accumbens (NAcc). DLPFC transmits reward representations to NAcc through glutamatergic projections that guide goal-directed behavior. If DLPFC fails to activate when required, a common observation in substance use disorder, target neurons in the NAcc core do not receive critical information needed to select the appropriate outcome, causing acquired maladaptive response patterns to persist (e.g. drug consumption). Higher functional connectivity between DLPFC and NAcc may be achieved by stimulating DLPFC while subjects perform engaging executive functioning tasks. TDCS is a non-invasive brain stimulation technique that can modulate brain connectivity. DLPFC stimulation may increase input to NAcc to facilitate proper selection of goal-directed behavior and may also decrease craving in individuals with substance use. Combination of active tDCS and cognitive training increases frontal-striatal resting state functional connectivity (RSFC) and reduces time to relapse in alcohol use disorder (AUD). The investigators' neuroimaging studies have identified a key frontal-striatal network associated with treatment outcome: low frontal-striatal RSFC predicts relapse and high frontal-striatal RSFC supports long-term abstinence. These neuroimaging findings highlight the key role of frontal-striatal RSFC in supporting long-term abstinence. In the investigators' pilot randomized controlled study of 11 participants with alcohol use disorder designed to enhance frontal-striatal RSFC and cognition, 6 participants who received active tDCS (2mA anode over left DLPFC, cathode over right DLPFC) were compared to 5 participants who received sham tDCS. Intervention sessions were 46 minutes for five consecutive days. All participants underwent concurrent cognitive training during the 46 minute session. Rest fMRI data was collected pre- and post-intervention. The investigators found significant Group (active vs sham tDCS) x Time interaction in prefrontal-nucleus accumbens (NAcc), with prefrontal-NAcc RSFC increase in the active tDCS group but not the sham group. Findings suggest active tDCS during cognitive training can increase frontal-striatal RSFC in addiction. Eight-month follow-up showed that those receiving sham and cognitive training had a significantly shorter time to relapse than those who received active tDCS and cognitive training. While these are promising findings for AUD, it is important to further explore dose effects, to determine whether a higher dose of the intervention (more tDCS intervention days) will support longer abstinent in AUD. A source of treatment response variability could stem from differences between participants in baseline genetic profiles or epigenetic changes over the course of treatment. Genetic polymorphisms, especially in genes important for neuroplasticity, may also mediate neuroplastic changes underlying the effects of tDCS, as has been demonstrated with gene brain-derived neurotrophic factor. In light of these genetic influences on key tenants of the study - i.e. treatment response in alcohol use disorder and physiological effects of tDCS - genetic samples will be collected from participants to determine whether genetic or epigenetic variations may affect response to the cognitive training and tDCS intervention. This information may help inform the development of more individually-tailored treatment protocols for AUD in the future. As this is a secondary aim, participants will be given the choice in the Consent Form to opt in or out of the genetic sampling procedure. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05062369
Study type Interventional
Source University of Minnesota
Contact Jazmin Camchong, PhD
Phone (612) 842-8704
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date December 2021
Completion date September 2025

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