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 — DEVICE
    An 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 Stimulation
    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.
  • Other: sham / aDBS / cDBS
    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.
  • Other: cDBS / sham / aDBS
    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.

Primary Outcome Measure

Incidence of adverse events during sEEG phase [ Time Frame: Up to 2 weeks during sEEG phase. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Catherine Borror, BS
415-514-6551
Sierra Brandts, BS
415-514-6551
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)

Find similar trials in San Francisco, CA

Related Studies