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NCT05558358 · ClinicalTrials.gov registry record · Phase 1
Deep Brain Stimulation (DBS) for Methamphetamine Use Disorder
A Phase 1 study of Methamphetamine Use Disorder, sponsored by University of Colorado, Denver.
- Active
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
- 1
- Study location
NCT05558358 is a Phase 1 study of Methamphetamine Use Disorder that is active but no longer recruiting, run by University of Colorado, Denver. The registered enrollment target is 2 participants, below the 55-participant average among 12 other Methamphetamine Use Disorder trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05558358, a Phase 1 study of Methamphetamine Use Disorder, is active but no longer recruiting, sponsored by University of Colorado, Denver.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
- 1
- Study location
Study Summary
We will evaluate the effects of deep brain stimulation (DBS) of bilateral nucleus accumbens (NAc) added to background treatment for treatment refractory Methamphetamine Use Disorder (MUD). This is a small randomized cross-over study to demonstrate feasibility and safety, test treatment outcomes (use, craving), and identify novel biological targets (NAc local field potentials (LFP) and functional MRI).
Conditions Studied
Interventions
- DEVICE Experimental 1 - DBS of bilateral NAc - 6 months of active stimulation -- > 6 months of sham stimulation
- DEVICE Experimental 2 - DBS of bilateral NAc - 6 months of sham stimulation -- > 6 months of active stimulation
Study Locations (1)
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2024-01-15 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05558358
The ClinicalTrials.gov registry entry for NCT05558358 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55-participant average among 12 other Methamphetamine Use Disorder trials with a reported enrollment target (96% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Methamphetamine Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Experimental 1 - DBS of bilateral NAc - 6 months of active stimulation -- > 6 months of sham stimulation is the first listed.
NCT05558358 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT05558358 about?
NCT05558358 is a clinical study titled "Deep Brain Stimulation (DBS) for Methamphetamine Use Disorder". We will evaluate the effects of deep brain stimulation (DBS) of bilateral nucleus accumbens (NAc) added to background treatment for treatment refractory Methamphetamine Use Disorder (MUD). This is a small randomized cross-over study to demonstrate feasibility and safety, test treatment outcomes (use...
What is the current status of trial NCT05558358?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2024-01-15. Estimated completion is 2026-05-31.
What conditions does trial NCT05558358 study?
This clinical trial studies the following conditions: Methamphetamine Use Disorder.
What interventions are being tested in trial NCT05558358?
The interventions under investigation include: Experimental 1 - DBS of bilateral NAc - 6 months of active stimulation -- > 6 months of sham stimulation (DEVICE), Experimental 2 - DBS of bilateral NAc - 6 months of sham stimulation -- > 6 months of active stimulation (DEVICE).
Who is sponsoring clinical trial NCT05558358?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05558358 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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