Deep Brain Stimulation (DBS) for Methamphetamine Use Disorder

NCT05558358 | Active Not Recruiting Phase 1 DMC FDA Device

• 2 other identifiers: 18-0254UG3DA054746
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of study-emergent adverse events

  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.

  56 weeks

Secondary Outcomes (12)

• Methamphetamine use

  Measured during weeks 26-30 and weeks 52-56 (last month on stimulation and sham)

• Methamphetamine use

  Measured during weeks 26-30 and weeks 52-56 (last month on stimulation and sham)

• Methamphetamine craving

  Comparing weeks 26-30 and weeks 52-56

• Local Field Potential

  baseline through week 56

• MRI

  56 weeks

Study Arms (2)

1

EXPERIMENTAL

Randomized sham-controlled crossover design - participants have baseline assessments/evaluation, 1 week detoxification, surgery, 30 days residential care, then begin DBS stimulation, 12 weeks IOP/CM and are followed for 52 weeks.

Device: Experimental 1 - DBS of bilateral NAc - 6 months of active stimulation -- > 6 months of sham stimulation

2

EXPERIMENTAL

Randomized sham-controlled crossover design - participants have baseline assessments/evaluation, 1 week detoxification, surgery, 30 days residential care, then begin DBS stimulation, 12 weeks IOP/CM and are followed for 52 weeks.

Device: Experimental 2 - DBS of bilateral NAc - 6 months of sham stimulation -- > 6 months of active stimulation

Interventions

Experimental 1 - DBS of bilateral NAc - 6 months of active stimulation -- > 6 months of sham stimulation DEVICE

6 months of active stimulation -- \> 6 months of sham stimulation

1

Experimental 2 - DBS of bilateral NAc - 6 months of sham stimulation -- > 6 months of active stimulation DEVICE

6 months of sham stimulation -- \> 6 months of active stimulation

2

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (men and non-pregnant or nursing women) between 22-65 years of age will be eligible for enrollment, if meeting the following criteria:
• Current diagnosis of DSM-5 MUD (with past year specifier of severe and at least a 5-year history);
• Failed at least 2 prior treatment episodes (defined as outpatient or inpatient, utilizing a previously validated psychosocial treatment for addiction such as cognitive behavioral therapy, contingency management, motivational interviewing (Stuart et al., 2019) and not counting episodes with only detoxification) for MUD, with at least 1 episode having been residential;
• Provides a urine drug screen positive for mAMP;
• Endorses at least 10 days of mAMP use in the past month;
• Able to complete 1 week of inpatient detoxification prior to surgery and 4 weeks of inpatient treatment following surgery;
• No change in current psychiatric medication regimen, or medication free, for at least 4 weeks prior to entry;
• Able to provide informed consent;
• Able to comply with all testing and follow-up requirements as defined by study protocol (including providing a home address and two local collateral contacts);
• Medically able to undergo DBS procedure as assessed by Study Neurosurgeon;
• Has platelet count, PT and PTT within normal laboratory limits;
• Adequate English proficiency for study consent, and completion of the study instruments;
• Reside in the state of Colorado.

You may not qualify if:

• Lifetime non-substance-induced psychotic disorders, schizophrenia, or schizoaffective disorder defined by DSM-5;
• Current diagnosis of DSM-5 drug use disorder other than stimulant, alcohol, cannabis or nicotine use disorder;
• Non-substance-induced manic episode within the past 3 years or major depressive episode in the past year;
• Current clinically significant neurological disorder or medical illness;
• Presence of a clinically significant abnormality on preoperative MRI;
• Inability to have an MRI;
• Inability to undergo general anesthesia required for tunneling of extension cable and placement of the batteries;
• Pregnancy or lack of use of effective contraception in women of childbearing age, as assessed by urine pregnancy test and self-report (participants will consent to continue effective contraceptives during the study);
• Coagulopathy, as determined by PT, PTT, platelet count, and medical history;
• History of recurrent infections;
• Inability to adhere to the requirements of the study;
• Imminent risk of suicide as determined by Study Psychiatrist's assessment and investigators' clinical judgment or past-year suicide attempt, any positive response on baseline Columbia Suicide Severity Scale or history of parental completed suicide;
• Active criminal justice involvement (i.e., any unresolved legal problems that could jeopardize continuation or completion of the study);
• History of head injury with loss of consciousness for more than 15 minutes, neurological illness (including primary seizure disorder);
• Diagnosis of dementia;

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of Nebraska: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and all study personnel are blinded to subject assignment except the physician completing DBS programming.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants undergo surgery. Some receive 6 months of active DBS stimulation of the bilateral nucleus accumbens followed by 6 months of sham stimulation. While some receive the opposite order.

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 28, 2022
• Study Start: January 15, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)