Individualized Adaptive Deep Brain Stimulation in Opioid Use Disorder
Part of paid clinical trials in San Francisco, California.
- Sponsor
- University of California, San Francisco
- Study ID
- NCT07214467
- Status
- Recruiting
Conditions
- Opioid Use Disorder (OUD)
- Substance Use Disorder (SUD)
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Deep Brain Stimulation — DEVICEAn individualized aDBS protocol will be used to examine therapeutic effect.
Study Details
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 better outcomes like reductions in craving and opioid use.
Key Dates
- Start date
- Oct 24, 2025
- Status verified
- Oct 2025
- Primary completion
- Nov 22, 2031
- Completion
- Nov 22, 2031
Study Design
- Enrollment
- 6 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Other: aDBS / cDBS / sham StimulationParticipants 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.
- Other: sham / aDBS / cDBSParticipants 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.
- Other: cDBS / sham / aDBSParticipants 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.
Primary Outcome Measure
Incidence of adverse events during sEEG phase [ Time Frame: Up to 2 weeks during sEEG phase. ]
Central Contacts
- Catherine Borror, BS415-514-6551
- Sierra Brandts, BS415-514-6551
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | Khaled Moussawi, MD, PhD (PRINCIPAL_INVESTIGATOR) Edward Chang, MD (SUB_INVESTIGATOR) Andrew Krystal, MD (SUB_INVESTIGATOR) Kristin Sellers, PhD (SUB_INVESTIGATOR) Philip Star, MD, PhD (SUB_INVESTIGATOR) |
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