Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder

West Virginia University

Status: Completed

Conditions: Opioid-Related Disorders

Treatments: Device: Deep Brain Stimulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05903495

2301715195

Details and patient eligibility

About

The purpose of this clinical study is to investigate the safety, tolerability, and feasibility of Deep Brain Stimulation (DBS) of the nucleus accumbens (NAc) and ventral internal capsule (VC) for participants with treatment refractory opioid use disorder (OUD) who have cognitive, behavioral, and functional disability.

Full description

The overarching goal of this study is to evaluate the safety, tolerability, feasibility and impact on outcomes of NAc/VC DBS for treatment refractory OUD. In treatment refractory OUD, innovative approaches and more invasive interventions including DBS are warranted to improve outcomes.

Enrollment: 1 patient

Sex: All

Ages: 22 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 22-50 years at time of enrollment.
• Fulfills current DSM-5 diagnostic criteria for severe OUD with at least a 5-year history.
• Participants may have comorbid SUD diagnoses at a mild, moderate or severe level, however, OUD must be the primary disorder for which the individual is seeking treatment and the other use disorders must occur in the context of relapse.
• At least one lifetime overdose survival.
• Demonstrated greater than five years of refractory symptoms of OUD.

Exclusion criteria

• Diagnosis of acute myocardial infarction or cardiac arrest 1 within the previous 6 months.
• Past or present diagnosis of schizophrenia, psychotic disorder, bipolar disorder, or untreated depression other than one determined to be substance induced.
• Unable to undergo MR-imaging

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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1 participants in 2 patient groups

DBS-ON

Experimental group

Description:

Titration will be based on stimulation parameters used in previous studies examining the role of DBS of the NAc in the treatment o OCD and depression as well as the parameters utilized in the initial pilot study conducted by the team.

Treatment:

Device: Deep Brain Stimulation

DBS-OFF

Sham Comparator group

Description:

For participants randomized to the "DBS-OFF" condition, titration sessions will be conducted identically to the "DBS-ON" arm, the only difference is that no stimulation is delivered and therefore, no actual adjustments made

Treatment:

Device: Deep Brain Stimulation