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 — DEVICEDeep 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 DBSSubjects will receive bilateral DBS of the NAc
Primary Outcome Measure
Opioid use/abstinence [ Time Frame: 6 months ]
Central Contacts
- Nestor Tomycz, MD412-359-6200
- Donald Whiting, MD412-359-6200
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| AHN Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | 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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