Deep Brain Stimulation Effects In Patients With Opioid Use Disorder

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study ID
NCT04354077
Status
Recruiting

Conditions

  • Opioid-use Disorder

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • DBS of the NAc — DEVICE
    Deep Brain Stimulation of the Nucleus Accumbens

Study Details

This is a pilot study to evaluate the safety and efficacy of deep brain stimulation (DBS) of the nucleus accumbens (NAc) as adjunctive treatment for treatment-refractory opioid use disorder. This study will include 3 individuals with opioid use disorder and relapsing opioid use despite active participation in a drug addiction treatment program.

Key Dates

Start date
Feb 7, 2022
Status verified
Jan 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
3 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NAc DBS
    Subjects will receive bilateral DBS of the NAc

Primary Outcome Measure

Opioid use/abstinence [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AHN Allegheny General HospitalPittsburghPennsylvania15212
Clinical Trials Contact
Nestor Tomycz, MD (PRINCIPAL_INVESTIGATOR)
Donald Whiting, MD (SUB_INVESTIGATOR)
Carol Schramke, PhD (SUB_INVESTIGATOR)
Amanda Webb, PA (SUB_INVESTIGATOR)
Stuart Fisk, CRNP (SUB_INVESTIGATOR)
Heather Richards, MD (SUB_INVESTIGATOR)
Elizabeth Cuevas, MD (SUB_INVESTIGATOR)

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