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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: Active Phase 1 study of Methamphetamine Use Disorder, sponsored by University of Colorado, Denver.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Participants will be closely monitored for adverse events throughout the study including regular meetings with study staff and administration of the COMBINE SAFTEE during each programming session.
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 |
What the registry record for NCT05558358 still lists
NCT05558358 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 55-participant average among 12 other Methamphetamine Use Disorder trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Methamphetamine Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05558358's enrollment target sits among peer trials
2 13th of 12 the lowest of 12 other Methamphetamine Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Methamphetamine Use Disorder 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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