Deep Brain Stimulation for Addiction

(aDBS OUD Trial)

Overseen By Sierra Brandts, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Buprenorphine

Disqualifiers: Pregnancy, Non-English, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a personalized brain treatment called Deep Brain Stimulation (DBS) can safely reduce cravings and opioid use in individuals with severe opioid use disorder (OUD). Participants will undergo various forms of DBS and a placebo (sham) throughout the trial. The study seeks individuals who have struggled with opioid addiction for over five years and have not achieved sustained recovery despite multiple treatments. Participants should actively seek treatment for their OUD and have a stable living situation to support adherence to the study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for OUD.

Do I need to stop my current medications to join the trial?

The trial requires participants to start or switch to buprenorphine (a medication for opioid use disorder) if they are not already on it. The protocol does not specify if you need to stop other medications, but you must be willing to take buprenorphine during the study.

What prior data suggests that this individualized adaptive deep brain stimulation is safe for addiction treatment?

Research has shown that adaptive deep brain stimulation (aDBS) is generally safe and well-tolerated. In studies involving individuals with Parkinson's Disease, aDBS proved effective and safe over the long term. Participants in these studies managed the treatment well, without experiencing severe side effects.

For continuous deep brain stimulation (cDBS), research indicates it can influence brain areas to help manage addiction-related behaviors. Studies suggest cDBS is safe, practical, and may help reduce cravings and emotional symptoms in individuals dealing with addiction.

Both aDBS and cDBS have demonstrated promising safety results in various conditions, suggesting they may be manageable for participants in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the use of Deep Brain Stimulation (DBS) for addiction because it offers a unique approach compared to traditional treatments like behavioral therapy and medication. Unlike these standard options, DBS targets specific brain areas involved in addiction by delivering precise electrical impulses. This method allows for real-time adaptation to the brain's changing activity, potentially providing more effective and personalized treatment. Additionally, DBS can offer results without the long wait times associated with other therapies, offering hope for faster and more sustained recovery.

What evidence suggests that this trial's treatments could be effective for addiction?

This trial will evaluate different forms of deep brain stimulation for addiction. Research has shown that personalized adaptive deep brain stimulation (aDBS), one of the methods tested in this trial, holds promise. It has significantly improved symptoms in conditions like Parkinson's disease. For addiction, aDBS might offer better results when customized to match an individual's brain activity. Another method under study is continuous deep brain stimulation (cDBS), which has also improved addiction symptoms, with studies reporting an average improvement of nearly 60% in clinical measures for substance use disorders. Previous research suggests both methods may help reduce cravings and drug use. ^{4 6 7 8 9}

Who Is on the Research Team?

Khaled Moussawi, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals struggling with opioid addiction who are seeking new treatment options. Specific eligibility criteria details were not provided, so interested participants should contact the study organizers for more information.

Inclusion Criteria

* Adults (all genders) 22 to 75 years old.

* Current diagnosis of severe primary opioid use disorder (OUD) (\>= 6 on DSM-5 OUD criteria) (any form of opioid use).

* History of opioid use for more than 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

sEEG Mapping

To identify individualized brain targets for sensing neural biomarkers of craving and stimulation to mitigate craving

2 weeks

Treatment

Participants undergo adaptive, continuous, and sham deep brain stimulation, each lasting 4 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Individualized Adaptive Deep Brain Stimulation

Trial Overview The study is testing whether personalized Deep Brain Stimulation (DBS), tailored to each individual's brain activity, can safely reduce cravings and opioid use in people with opioid addiction.

How Is the Trial Designed?

Group I: sham / aDBS / cDBS Experimental Treatment 1 Intervention

Participants in this group will first receive sham stimulation, followed by adaptive deep brain stimulation (aDBS), and finally continuous deep brain stimulation (cDBS). Each period of the randomized controlled trial (aDBS, cDBS, and sham) will last 4 months.

Group II: cDBS / sham / aDBS Experimental Treatment 1 Intervention

Participants in this group will first receive continuous deep brain stimulation (cDBS), followed by sham stimulation, and finally adaptive deep brain stimulation (aDBS). Each period of the randomized controlled trial (aDBS, cDBS, and sham) will last 4 months.

Group III: aDBS / cDBS / sham Stimulation Experimental Treatment 1 Intervention

Participants in this group will first receive adaptive deep brain stimulation (aDBS), followed by continuous deep brain stimulation (cDBS), and finally a sham stimulation. Each period of the randomized controlled trial (aDBS, cDBS, and sham) will last 4 months.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12537409/

Evaluation of the therapeutic effect of adaptive deep brain ... Previous studies have demonstrated that adaptive deep brain stimulation (aDBS) can effectively improve motor symptoms in Parkinson's disease ...

2. nature.com nature.com/articles/s41398-024-03060-1

A systematic review of deep brain stimulation for substance ... Clinical studies suggest that DBS as a therapeutic option for treatment-refractory SUDs has not yielded high enough remission rates that would ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07214467?term=NA

Individualized Adaptive Deep Brain Stimulation in Opioid ... The purpose of this study is to determine if personalized (adaptive) Deep Brain Stimulation (DBS) based upon invasive brain mapping is safe and can lead to ...

4. medrxiv.org medrxiv.org/content/10.1101/2025.09.07.25335282v1.full

A Randomized Crossover Trial with Exploratory Analysis of ... The baseline clinical characteristics of patients may shape the results of aDBS. These findings support comparable efficacy between treatments, ...

5. news.medtronic.com news.medtronic.com/Groundbreaking-study-published-in-the-Journal-of-the-American-Medical-Association-JAMA-Neurology-demonstrates-effectiveness-of-Medtronic-BrainSense-TM-Adaptive-deep-brain-stimulation-for-people-with-Parkinsons

Groundbreaking study published in the Journal of ... Findings show that aDBS is safe, well tolerated, and can provide an effective therapy compared to continuous DBS (cDBS).2. “This publication ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40982287/

Long-Term Personalized Adaptive Deep Brain Stimulation ... Conclusions and relevance: In this study, long-term aDBS was tolerable, effective, and safe in people with PD who were previously stable while ...

7. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2839117

Long-Term Personalized Adaptive Deep Brain Stimulation ... The ADAPT-PD trial demonstrated the tolerability, efficacy, and safety of long-term at-home aDBS in 45 people with moderate to advanced PD ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P960009S478B.pdf

P960009/S478 Summary of Safety and Effectiveness (SSED) The current supplement (S478) introduces a new optional programming feature called adaptive deep brain stimulation (aDBS) for Parkinson's Disease in existing ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT07214467?term=TREATMENt

Individualized Adaptive Deep Brain Stimulation in Opioid ... The purpose of this study is to determine if personalized (adaptive) Deep Brain Stimulation (DBS) based upon invasive brain mapping is safe and can lead to ...