- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07158853
- Original Trial
Combined tDCS and Cognitive Training as an Adjunctive Treatment in Opioid Use Disorder
February 10, 2026 updated by: University of Minnesota
The overall goal of this study is to investigate the added benefit of a neuromodulation intervention in individuals under buprenorphine maintenance treatment for OUD (bOUD).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clarista Berg
- Phone Number: 952-444-0137
- Email: berg2920@umn.edu
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota
-
Contact:
- Clarista Berg
- Phone Number: 612-625-3330
- Email: berg2920@umn.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- ability to provide consent and comply with study procedures
- Diagnostic and Statistical Manual of Mental Disorders criteria for OUD
- undergoing buprenorphine maintenance treatment. Participants may have current comorbid drug use, but primary diagnosis must be OUD
- Intention to remain in the addiction treatment program 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
- court mandated treatment
- pregnancy
- disrespectful behavior towards the investigators and staff.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: tDCS
All intervention sessions will use the Soterix Mini-CT Remote 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).
|
|
Placebo Comparator: Sham Electrodes
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electrodes will have the same montage as active tDCS (F3/F4), but current will be ramped down after the initial 30 seconds ramp-up period.
Thus, participants will feel the initial sensation associated with tDCS but will receive no active current for the rest of the stimulation period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
tDCS effect on circuit-based target engagement of a prefrontal-incentive salience network
Time Frame: immediately after the intervention
|
Compare change in correlation value (which represents the functional connectivity between pre-frontal cortex and prefrontal-incentive salience network) via paired t-test, from pre- to post-intervention
|
immediately after the intervention
|
|
tDCS effect on executive functioning
Time Frame: immediately after the intervention
|
Compare change in mean cognitive performance via paired t-test from pre-intervention cognitive assessment to post-intervention cognitive assessment (post-intervention mean cognitive score minus pre-intervention mean cognitive score) between active tDCS and sham groups
|
immediately after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jazmin Camchong, PhD, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 4, 2026
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
August 11, 2025
First Submitted That Met QC Criteria
September 2, 2025
First Posted (Actual)
September 8, 2025
Study Record Updates
Last Update Posted (Actual)
February 12, 2026
Last Update Submitted That Met QC Criteria
February 10, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Narcotic-Related Disorders
- Mental Disorders
- Substance-Related Disorders
- Chemically-Induced Disorders
- Opioid-Related Disorders
- Therapeutics
- Behavioral Disciplines and Activities
- Electric Stimulation Therapy
- Convulsive Therapy
- Psychiatric Somatic Therapies
- Electroshock
- Psychological Techniques
- Transcranial Direct Current Stimulation
Other Study ID Numbers
- PSYCH-2025-34164
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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