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NCT03382379 · ClinicalTrials.gov registry record · Phase 1
Transcranial Direct Current Stimulation to Modulate Top-Down Regulation for Drug Craving in Methamphetamine Use Disorder
A Phase 1 study, sponsored by Laureate Institute for Brain Research.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT03382379 is a Phase 1 study that has completed, run by Laureate Institute for Brain Research. The registered enrollment target is 60 participants.
The verdict
NCT03382379, a Phase 1 study, has completed, sponsored by Laureate Institute for Brain Research.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
Methamphetamine use disorder (MUD) is among the costliest and deadliest substance use disorders (SUDs) world-wide and is frequently comorbid with other mental health conditions. There is no empirically validated medical treatment for MUD. Drug craving is the signature aspect of MUD and other substance use disorders and has been associated with continued drug use and relapse. The investigators and others have shown that transcranial direct current stimulation (tDCS) over dorsolateral prefrontal cortex (DLPFC) can modulate drug craving in different SUDs. tDCS is a method of non-invasive brain stimulation and is a low-cost scalable technology without any serious side effects that delivers low levels of direct current (0.1-2 mAmp) transcranially. However, there are significant inter-individual differences in response to tDCS, which is not well understood but can have profound impact on efficacy. Meanwhile, there are no studies with neuroimaging to show how tDCS affects drug craving. Investigators propose the first combined tDCS/functional Magnetic Resonance Imaging (fMRI) study to examine the acute effects of tDCS on neural substrates underlying drug induced craving.
Interventions
- DEVICE Active transcranial Direct Current Stimulation (tDCS)
- DEVICE Sham transcranial Direct Current Stimulation (tDCS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-11-30 |
| Est. Completion | 2019-02-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03382379
The ClinicalTrials.gov registry entry for NCT03382379 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Laureate Institute for Brain Research, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Active transcranial Direct Current Stimulation (tDCS) is the first listed.
NCT03382379 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03382379 about?
NCT03382379 is a clinical study titled "Transcranial Direct Current Stimulation to Modulate Top-Down Regulation for Drug Craving in Methamphetamine Use Disorder". Methamphetamine use disorder (MUD) is among the costliest and deadliest substance use disorders (SUDs) world-wide and is frequently comorbid with other mental health conditions. There is no empirically validated medical treatment for MUD. Drug craving is the signature aspect of MUD and other substan...
What is the current status of trial NCT03382379?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2017-11-30. Estimated completion is 2019-02-10.
What interventions are being tested in trial NCT03382379?
The interventions under investigation include: Active transcranial Direct Current Stimulation (tDCS) (DEVICE), Sham transcranial Direct Current Stimulation (tDCS) (DEVICE).
Who is sponsoring clinical trial NCT03382379?
This trial is sponsored by Laureate Institute for Brain Research, which has 45 total clinical trials registered on ClinicalTrials.gov.
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