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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
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
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured during weeks 26-30 and weeks 52-56 (last month on stimulation and sham)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured during weeks 26-30 and weeks 52-56 (last month on stimulation and sham)
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,806 Previous Clinical Trials
2,822,401 Total Patients Enrolled
University of NebraskaOTHER
555 Previous Clinical Trials
1,145,380 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,589 Previous Clinical Trials
3,328,512 Total Patients Enrolled
1 Trials studying Methamphetamine Addiction
8 Patients Enrolled for Methamphetamine Addiction
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with dementia.I have a blood clotting disorder.I have a serious neurological condition or illness.I cannot have general anesthesia for a surgical procedure.I often get infections.I have been diagnosed with severe substance use disorder for at least 5 years.My psychiatric medication has been stable or I've been medication-free for the last 4 weeks.I am between 22 and 65 years old and not pregnant or nursing.I have been treated for my drug use disorder at least twice, including once in a residential setting.I can stay in the hospital for detox before and treatment after surgery for 5 weeks total.I have had a head injury with unconsciousness for over 15 minutes.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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