Combined tDCS and Cognitive Training as an Adjunctive Treatment in Opioid Use Disorder

NCT07158853 | Recruiting Phase 1 FDA Device

• 1 other identifier: PSYCH-2025-34164
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (2)

• tDCS effect on circuit-based target engagement of a prefrontal-incentive salience network

  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.

  immediately after the intervention

• tDCS effect on executive functioning

  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.

  immediately after the intervention

Study Arms (1)

tDCS

EXPERIMENTAL

All intervention sessions will use the Soterix Mini-CT Remote tDCS device

Device: Transcranial Direct Current Stimulation (tDCS)

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

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).

tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Pregnancy
• Disrespectful behavior towards the investigators and staff.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Jazmin Camchong, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Calvin Cahill

CONTACT

952-444-0137; cahil138@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: September 8, 2025
• Study Start: February 4, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)