Study | Research Studies | School of Medicine

Deep Brain Stimulation (DBS) for Methamphetamine Use Disorder

Primary Objective

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).

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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).

Details

Age

Adult

Eligibility

Inclusion Criteria: Adults (men and non-pregnant or nursing women) between 22-65 years of age will be eligible for enrollment, if they meet the following criteria: (1) Current diagnosis of DSM-5 MUD (with past year specifier of severe and at least a 5-year history); (2) Failed at least 2 prior treatment episodes (defined as outpatient or inpatient, utilizing a previously validated treatment for addiction, with at least 1 episode having been residential; (3) Able to complete 1 week of inpatient detoxification prior to surgery and 4 weeks of inpatient treatment following surgery; (4) Medically able to undergo DBS procedure as assessed by Study Neurosurgeon; (5) Reside in the state of Colorado. Other study inclusion/exclusion criteria will be evaluated by the study team.

Locations

Brain Imaging Center (BIC)
University of Colorado Hospital

Principal Investigator

Joseph Sakai

Study ID

Protocol Number: 18-0254

More information available at ClinicalTrials.gov: NCT05558358

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