Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder

June 20, 2025 updated by: University of Minnesota
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 transcrancial direct current stimulation (tDCS) for new addiction treatments that support long-term abstinence. This study will investigate whether the pairing of dorsolateral prefrontal cortex (DLPFC) stimulation and cognitive training can enhance functional connectivity between DLPFC and nucleus accumbens (NAcc). We have identified higher functional connectivity between DLPFC and NAcc in alcoholics that have successfully maintained abstinence for extended periods of time (7 years). This paired-neuromodulation approach can potentially be used as a therapeutic intervention to decrease substance use probability in addiction (e.g. opioid use disorder). The long term goal is to develop new addiction treatments that support long-term abstinence in opioid use disorder. The overall objective of this proposal is to enhance functional connectivity between DLPFC and NAcc as a therapeutic intervention to enhance cognition and reduce substance use rates in opioid use disorder.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Current diagnosis of opioid use disorder
  • Enrolled in a methadone treatment program for at least 2 months in Hennepin Healthcare and be clinically stable.
  • Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for opioid use disorder
  • Participants may have current comorbid drug use, but their primary substance use disorder diagnosis must to be based on opioid use.
  • Participants must have the intention to remain in the methadone treatment program until the end of the intervention portion of the study.

Exclusion Criteria:

  • Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness>30 min, HIV)
  • Head injury resulting in a skull fracture or a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
  • Any contraindications for tDCS or MRI scanning (tDCS contraindication: actively receiving treatment for seizures or epilepsy; MRI contraindications; metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder)
  • Current active psychosis or mania
  • Presence of a condition that would render study measures difficult or impossible to administer or interpret (e.g. current mania, active psychosis)
  • Primary current substance use disorder diagnosis on a substance other than opioid except for caffeine or nicotine
  • Current stimulant use disorder (need to be free of stimulant use for at least 1 month)
  • History of electroconvulsive therapy or cortical energy exposure within the past 12 months, including participation in any other neuromodulation studies
  • incarceration

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: tDCS with Cognitive Training
DLPFC stimulation with tDCS with simultaneous cognitive training
Device: Transcranial Direct Current Stimulation (tDCS)
Participants receive 10 sessions (2 5-visit blocks of 46 minutes) of active tDCS to DLPFC (dorsolateral prefrontal cortex)
Behavioral: Cognitive Training
Executive functioning tasks
Active Comparator: Sham tDCS with Cognitive Training
Sham tDCS with simultaneous cognitive training
Behavioral: Cognitive Training
Executive functioning tasks
Device: Sham Transcranial Direct Current Stimulation (tDCS)
Participants receive 10 sessions (1 5-visit block of 46 minutes of active tDCS and 1 5-visit block of sham tDCS)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
(A1) Average Number of Serious Adverse Events in Active and Sham Groups.
Time Frame: 2months post-intervention
Safety was defined as the prevalence of Serious Adverse Events for the study. Subjects were monitored for Serious Adverse Events from date of first intervention session until the final follow-up visit (2 months post-intevention). Subjects were monitored using the Symptom Rating Questionnaire (SRQ), Medication/Medical Update Interview, and medical chart review. Serious Adverse Events were defined as: Death, life threatening incidents, hospitalizations (initial or prolonged), disability or permanent damage, congenital anomaly or birth defect, or an event that required intervention to prevent permanent impairment or damage. Mean and standard deviation of Serious Adverse Events was recorded across groups. A lower number indicates fewer Serious Adverse Events.
2months post-intervention
(A2) Activation Levels in Brain Circuits in Active and Sham Groups.
Time Frame: 1-week post-intervention
Brain activation change from pre-intervention to post-intervention was planned to be compard between active tDCS and sham groups. We hypothesized that the active tDCS group will have a larger increase in brain circuit engagement than the sham group and, thus, a better outcome.
1-week post-intervention
(A3) Changes in Scaled Score on Digit Span Task.
Time Frame: 2 months post-intervention

Cognitive performance change was compared between active tDCS and sham groups. Cognitive performance change was defined as improvement on the WAIS-IV Digit Span (DS). Score was calculating by subtracting the DS scaled score at baseline from the DS scaled score at 2-Month Follow Up. We hypothesized that the active tDCS group will have a larger improvement in cognitive performance than the sham group. A higher number indicates a higher impact of cognitive training and, thus, a better outcome.

The DS Scaled Score has a range between 1 (min.) and 10 (max). Therefore, the computed difference between two DS Scaled Scores has a range of -9 (min.) to 9 (max.)
2 months post-intervention
(A4) Number of Participants Who Relapsed After Intervention.
Time Frame: 2 months post-intervention
Relapse was defined as any illiciit drug use (whether reported by the patient or reported as a positive drug screen in study or medical records) that occurred at some point between study intervention and the final follow-up visit (2 months post-intervention). Relapse was measured with the Timeline Follow Back questionnaire, saliva drug screen at the study visit, and chart review of urine drug screens. Relapse was coded 0 (did not relapse during the study) or 1 (relapsed during the study). We hypothesized that the active tDCS group will have a lower relapse rate than the sham group. A higher number indicates a higher count of participants with a relapse.
2 months post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Scaled Score on Digit Symbol Task.
Time Frame: 2-months post-intervention

"Durability of cognitive training was defined as improvement on the WAIS-IV Digit Scale Symbol/Coding (CD) test. The improvement period was measured between baseline and the study completion (2 months post-intervention). The score was calculated by subtracting the CD scaled score at baseline from the CD Scaled Score at 2-months post-intervention. A higher number indicates a higher impact on cognitive abilities, and a better outcome.

The CD Scaled Score has a range between 1 (min.) and 10 (max). Therefore, the computed difference between two CD Scaled Scores has a range of -9 (min.) to 9 (max.)"
2-months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jazmin Camchong, PhD, University of Minnesota
  • Principal Investigator: Kelvin Lim, MD, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PSYCH-2018-26724
  • 1UG3DA048508-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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