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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: Completed Phase 1 study, sponsored by Laureate Institute for Brain Research.
NCT03382379 is a Phase 1 study that has completed, run by Laureate Institute for Brain Research. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Drug Cue Reactivity BOLD Signal is measured as average blood oxygen level dependent (BOLD) signal difference with voxel-wise analysis in the regions of interests (ROIs) (prefrontal cortex parcels, insula segments, striatum nuclei, thalamus nuclei and extended amygdala nuclei) in craving \> neutral contrast in drug cue exposure fMRI task with blocks of neutral and drug related images
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 |
What the finished NCT03382379 record still lists
NCT03382379 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Active transcranial Direct Current Stimulation (tDCS) is the first listed.
NCT03382379 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03382379's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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