Microcurrent Neurofeedback as an Adjunct to Standard Care for Substance Use Disorders

Overview

The goal of this clinical trial is to learn whether adding Microcurrent Neurofeedback (MCN) to standard residential treatment helps adults with substance use disorder more than standard treatment alone. It will also learn whether MCN is feasible to deliver in a residential treatment setting. The main questions it aims to answer are: Does adding MCN to Standard Care reduce substance cravings more than Standard Care alone? Does adding MCN to Standard Care reduce symptoms of depression, anxiety, and PTSD more than Standard Care alone? Is it feasible to deliver MCN sessions and collect study measurements within a residential treatment program? Researchers compared Standard Care plus MCN to Standard Care alone to see whether adding MCN improved outcomes beyond standard treatment. Participants: Were enrolled in residential substance use treatment for at least 4 weeks before joining the study Were randomly assigned to receive Standard Care plus MCN or Standard Care alone Those receiving MCN attended 12 sessions over 12 weeks, each lasting 30-45 minutes Completed questionnaires about cravings, depression, anxiety, and PTSD symptoms at the start of the study, at 6 weeks, and at 12 weeks

Substance use disorder (SUD) affects millions of adults in the United States, and many people who receive treatment continue to struggle with cravings and co-occurring symptoms of depression, anxiety, and post-traumatic stress disorder (PTSD), even in intensive residential treatment programs. Standard residential treatment typically includes medication (when appropriate), individual and group therapy, and peer support, but craving often persists despite these approaches, leaving room to explore additional treatments that might help. Microcurrent Neurofeedback (MCN) is a non-invasive technology that uses a person's own brainwave activity (EEG) to guide very low-intensity electrical stimulation delivered through sensors placed on the scalp. The goal is to help normalize patterns of brain activity that may be involved in craving and emotional distress. MCN has shown early promise in small studies for depression, anxiety, and PTSD in general (non-substance-use) populations, but before this study, no randomized trial had tested MCN specifically in adults being treated for substance use disorder. This study was conducted as a pilot and feasibility trial, meaning its main purpose was to generate early evidence and test whether this type of study could be carried out successfully in a residential treatment setting, rather than to provide a definitive answer about how well MCN works. Feasibility outcomes (such as how many people could be enrolled, how many completed the study, and whether the MCN sessions could be delivered as planned) were considered just as important as the clinical outcomes. Adults enrolled in residential substance use treatment at a partner treatment facility were invited to participate after completing a required 4-week stabilization period in the program. Eligible participants were randomly assigned, similar to a coin flip, to one of two groups: Standard Care plus MCN, or Standard Care alone. Random assignment helps ensure the two groups are similar at the start of the study, so that any differences seen later are more likely due to the treatment itself rather than pre-existing differences between participants. Participants assigned to receive MCN attended 12 sessions over 12 weeks, each lasting 30 to 45 minutes, delivered by trained staff in a private room at the treatment facility. Because of the nature of the treatment, participants and staff could not be blinded to which group a person was in (this is known as an open-label design). All participants, regardless of group, continued to receive their regular Standard Care throughout the study. All participants completed questionnaires about substance cravings, depression, anxiety, and PTSD symptoms at three points during the study: at the start (Baseline), at the midpoint (around 6 weeks), and at the end (around 12 weeks). These questionnaires are widely used, validated tools in mental health and addiction research. Because participants were enrolled in a residential treatment program, some left the program before completing the study, which is a known challenge in this type of research; the study's analysis approach was designed to account for this as much as possible. A subset of participants also had their brain activity recorded using EEG, and a smaller subset underwent MRI brain scans, to explore whether measurable changes in brain activity or structure accompanied any changes in symptoms. These neuroimaging findings are being analyzed and reported separately from the main clinical results. This study did not directly measure drug or alcohol use, relapse, or abstinence; it focused specifically on craving and psychiatric symptoms. Findings from this pilot study are intended to inform the design of a larger, more definitive future trial.