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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
Adults (men and non-pregnant or nursing women) between 22-65 years of age
Failed at least 2 prior treatment episodes for MUD, with at least 1 episode having been residential
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

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 22 and 65 years old and not pregnant or nursing.
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I have been treated for my drug use disorder at least twice, including once in a residential setting.
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I can stay in the hospital for detox before and treatment after surgery for 5 weeks total.
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My psychiatric medication has been stable or I've been medication-free for the last 4 weeks.
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I have been diagnosed with severe substance use disorder for at least 5 years.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of study-emergent adverse events
Secondary outcome measures
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
1,732 Previous Clinical Trials
2,143,543 Total Patients Enrolled
University of NebraskaOTHER
537 Previous Clinical Trials
1,143,949 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,465 Previous Clinical Trials
2,618,628 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment targeting senior citizens for participation?

"This medical trial is looking for patients aged between 22 and 65 years old."

Answered by AI

Are there any enrollment opportunities currently available for this clinical trial?

"Affirmative, clinicaltrials.gov confirms that this trial is still recruiting subjects. This research was initiated on January 1st 2023 and the latest update occurred 13 days later. Currently, they are looking for 5 volunteer candidates at one medical centre."

Answered by AI

How many participants are accepted for enrollment in this trial?

"Indeed, the details on clinicaltrials.gov confirm that this medical experiment is currently in search of participants. This trial was first published on January 1st 2023 and edited most recently on January 13th 2023. The research team needs to find 5 individuals at a single site."

Answered by AI

Who has the opportunity to partake in this scientific endeavor?

"This trial is searching for 5 adults aged between 22 and 65 with an addiction to methamphetamine. Further, they must exhibit the following qualifications: Capable of giving voluntary consent; Physically able to go through a DBS procedure as judged by Study Neurosurgeon; Willingness to abide by all testing/follow-up requirements outlined in study protocol (including having access to their own residence and two local contacts); At least one emergency room visit or hospitalization related to mAMP use; One week of residential detoxification before surgery plus 4 weeks of post-surgical treatment at a medical facility ; An active DSM-5 MUD diagnosis that"

Answered by AI

Who else is applying?

What site did they apply to?
University of Colorado Anschutz Medical Campus
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
Deep Brain Stimulation (DBS) for Methamphetamine Use Disorder
2024. "Deep Brain Stimulation (DBS) for Methamphetamine Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05558358.
All > Dbs
~3 spots leftby Feb 2025
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