NCT07158853 · University of Minnesota
Combined tDCS and Cognitive Training as an Adjunctive Treatment in Opioid Use Disorder
What this study is about
The overall goal of this study is to investigate the added benefit of a neuromodulation intervention in individuals taking medication for treatment for Opioid Use Disorder(OUD).
View original scientific description
The overall goal of this study is to investigate the added benefit of a neuromodulation intervention in individuals taking medication for treatment for Opioid Use Disorder(OUD).
Interventions
DEVICE
Transcranial Direct Current Stimulation (tDCS)
We will deliver 2-mA tDCS current intensity during a 30 minute stimulation period (including a 30-second ramp-up and 30-second ramp-down period) to the dorsolateral prefrontal cortex. Electrodes will be fixed on marked locations based on the 10-20 EEG system. Anodal stimulating electrode will be over the left DLPFC (F3) and cathodal electrode over the right DLPFC (F4).
Primary outcome measures
tDCS effect on circuit-based target engagement of a prefrontal-incentive salience network
Time frame: immediately after the intervention
To assess changes in target engagement, we will measure the change in resting-state functional connectivity (measured as a Pearson correlation coefficient, r) between the prefrontal cortex and the incentive salience network from pre- to post-intervention using a paired t-test. The connectivity metric ranges from a minimum value of -1.0 (perfectly negative correlation) to a maximum value of 1.0 (perfectly positive correlation). Higher scores indicate stronger functional connectivity (greater top-down regulation), representing a better outcome.
tDCS effect on executive functioning
Time frame: immediately after the intervention
To assess changes in executive functioning, we will measure the change in executive functioning from pre- to post-intervention using a repeated measures t-test. Cognitive performance will be assessed via a behavioral battery spanning cognitive flexibility, working memory, inhibitory control, and delay discounting (utilizing standardized Pearson assessments and a computerized delay discounting task). Performance metrics across tasks will be converted to standardized z-scores (typically ranging from -3.0 to +3.0). The primary endpoint is the post-intervention mean z-score minus the pre-intervention mean z-score. A positive change score indicates an increase in executive functioning, representing a better clinical outcome.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Ability to provide consent and comply with study procedures
- Diagnostic and Statistical Manual of Mental Disorders criteria for OUD
- Undergoing medication treatment for OUD. Participants may have current comorbid drug use, but primary diagnosis must be OUD
- Intention to remain in the study until intervention completion.
Exclusion criteria
- Any medical condition with neurological sequelae
- Head injury resulting in skull fracture or loss of consciousness of \>30 minutes
- Any tDCS or MRI contraindication (tDCS: history of seizures, metallic cranial plates/screws or implanted device, history of eczema on scalp. MRI: unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, pregnancy, breathing or movement disorder, or claustrophobia)
- Any psychotic disorder (participants with other treated and stable psychiatric disorders will be included)
- Presence of a condition that would render study measures impossible to administer or interpret
- Age younger than 18
- Primary current substance use disorder on a substance other than opioids except for caffeine or nicotine
- In treatment instead of jail
- Disrespectful behavior towards the investigators and staff.
Where
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations