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Deep Brain Stimulation (DBS) for Methamphetamine Use Disorder

NCT05558358 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-04-30

No results posted yet for this 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

  • Methamphetamine Use Disorder

Interventions

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

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of Nebraska

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05558358 on ClinicalTrials.gov