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NCT04495673 · ClinicalTrials.gov registry record · NA
Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder
A NA study, sponsored by University of Minnesota.
- Terminated
- Registry status
- NA
- Development phase
- 9
- Enrollment target
NCT04495673: Clinical Trial NA study, sponsored by University of Minnesota.
NCT04495673 is a NA study that was terminated before completion, run by University of Minnesota. The registered enrollment target is 9 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04495673, a NA study, was terminated before completion, sponsored by University of Minnesota.
- TERMINATED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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 permane
Interventions
- DEVICE Transcranial Direct Current Stimulation (tDCS)
- BEHAVIORAL Cognitive Training
- DEVICE Sham Transcranial Direct Current Stimulation (tDCS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2021-01-11 |
| Est. Completion | 2022-02-22 |
| Phase | NA |
Why NCT04495673 stopped before completion
NCT04495673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Transcranial Direct Current Stimulation (tDCS) is the first listed.
NCT04495673 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04495673 about?
NCT04495673 is a clinical study titled "Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder". 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-t...
What is the current status of trial NCT04495673?
This trial is currently terminated. It is a NA study. The enrollment target is 9 participants. The study started on 2021-01-11. Estimated completion is 2022-02-22.
What interventions are being tested in trial NCT04495673?
The interventions under investigation include: Transcranial Direct Current Stimulation (tDCS) (DEVICE), Cognitive Training (BEHAVIORAL), Sham Transcranial Direct Current Stimulation (tDCS) (DEVICE).
Who is sponsoring clinical trial NCT04495673?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04495673's enrollment target sits among peer trials
9 1975th of 2000 higher than 25 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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