← Back to Search

Device

Deep Brain Stimulation for Methamphetamine Addiction

Phase 1 & 2
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured during weeks 26-30 and weeks 52-56 (last month on stimulation and sham)
Awards & highlights

Summary

This trial will test if a brain stimulation technique can help people with Methamphetamine Use Disorder who haven't responded to other treatments.

Who is the study for?
This trial is for adults aged 22-65 in Colorado with severe Methamphetamine Use Disorder (MUD), who've used meth at least 10 days in the past month and failed two prior treatments. They must test positive for meth, complete detox/surgery prep, have stable mental health treatment if any, and be medically fit for DBS surgery.
What is being tested?
The study tests Deep Brain Stimulation (DBS) of the nucleus accumbens to treat MUD. Participants will receive either active or sham stimulation first, then switch after six months. The goal is to assess safety, feasibility, impact on drug use/craving, and explore brain activity changes through MRI.
What are the potential side effects?
Potential side effects may include discomfort at the implant site, headache or nausea post-surgery; mood changes like depression or anxiety; possible seizure risk; and hardware-related complications such as infection or device malfunction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured during weeks 26-30 and weeks 52-56 (last month on stimulation and sham)
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured during weeks 26-30 and weeks 52-56 (last month on stimulation and sham) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of study-emergent adverse events
Secondary study objectives
Anhedonia
Behavioral Inhibition System/Behavioral Approach System (BIS/BAS)
Delay Discounting
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment1 Intervention
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.
Group II: 1Experimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,786 Previous Clinical Trials
2,787,603 Total Patients Enrolled
University of NebraskaOTHER
554 Previous Clinical Trials
1,145,431 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,543 Previous Clinical Trials
3,249,371 Total Patients Enrolled
1 Trials studying Methamphetamine Addiction
8 Patients Enrolled for Methamphetamine Addiction

Media Library

DBS of bilateral NAc (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05558358 — Phase 1 & 2
Methamphetamine Addiction Research Study Groups: 1, 2
Methamphetamine Addiction Clinical Trial 2023: DBS of bilateral NAc Highlights & Side Effects. Trial Name: NCT05558358 — Phase 1 & 2
DBS of bilateral NAc (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05558358 — Phase 1 & 2
~2 spots leftby Feb 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top