NCT05558358

Deep Brain Stimulation (DBS) for Methamphetamine Use Disorder

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

In a randomized cross-over design of DBS of the nucleus accumbens (NAc) for treatment refractory methamphetamine use disorder (MUD, n=5), we will test safety, feasibility, effect on clinical outcomes (craving and use), and seek to identify biological targets (using cue craving during recording of local field potentials and MRI).

Conditions

• Methamphetamine Use Disorder

Interventions

Type	Name	Description
DEVICE	Experimental 1 - DBS of bilateral NAc - 6 months of active stimulation -- > 6 months of sham stimulation	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	6 months of sham stimulation -- \> 6 months of active stimulation

Timeline

• Start date: 2024-01-15
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2022-09-28
• Last updated: 2025-04-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study