Trial Outcomes & Findings for Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder (NCT NCT05903495)
NCT ID: NCT05903495
Last Updated: 2026-03-06
Results Overview
Incidence of Study-Emergent Adverse Events. The safety/tolerability primary endpoint will be assessed comparing Grade 3 and 4 adverse events between the Active (DBS-ON) and Sham (DBS-OFF) arms throughout Phase IV (Outpatient Week 12). We will also categorize adverse events by organ system and assess relatedness to any aspect of this proof-of-concept study. Statistical tests will be performed at the request of the Data and Safety Monitoring Board (DSMB).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
Outpatient Week 12
Results posted on
2026-03-06
Participant Flow
Participant milestones
| Measure |
DBS-ON Only
Titration will be based on stimulation parameters used in previous studies examining the role of DBS of the NAc in the treatment of OCD and depression as well as the parameters utilized in the initial pilot study conducted by the team. Participants receive active stimulation after surgery and throughout the remainder of the study.
Deep Brain Stimulation: randomized, sham-controlled, partial crossover study investigating DBS, targeting the nucleus accumbens (NAc) and ventral internal capsule (VC), for participants with severe, treatment refractory OUD.
|
DBS-OFF, Then DBS-ON
Titration sessions will be conducted identically to the "DBS-ON" arm, the only difference is that no stimulation is delivered for the first 12 weeks (post surgery) and therefore, no actual adjustments made. At Study Week 12, stimulation is turn on and continues for the remainder of the study.
Deep Brain Stimulation: randomized, sham-controlled, partial crossover study investigating DBS, targeting the nucleus accumbens (NAc) and ventral internal capsule (VC), for participants with severe, treatment refractory OUD.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder
Baseline characteristics by cohort
| Measure |
DBS-ON Only
n=1 Participants
Titration will be based on stimulation parameters used in previous studies examining the role of DBS of the NAc in the treatment of OCD and depression as well as the parameters utilized in the initial pilot study conducted by the team. Participants receive active stimulation after surgery and throughout the remainder of the study.
Deep Brain Stimulation: randomized, sham-controlled, partial crossover study investigating DBS, targeting the nucleus accumbens (NAc) and ventral internal capsule (VC), for participants with severe, treatment refractory OUD.
|
DBS-OFF, Then DBS-ON
Titration sessions will be conducted identically to the "DBS-ON" arm, the only difference is that no stimulation is delivered for the first 12 weeks (post surgery) and therefore, no actual adjustments made. At Study Week 12, stimulation is turn on and continues for the remainder of the study.
Deep Brain Stimulation: randomized, sham-controlled, partial crossover study investigating DBS, targeting the nucleus accumbens (NAc) and ventral internal capsule (VC), for participants with severe, treatment refractory OUD.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=76 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=76 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=41 Participants
|
—
|
1 participants
n=76 Participants
|
PRIMARY outcome
Timeframe: Outpatient Week 12Population: Only one participant enrolled in the study; assigned to the DBS-ON arm. No additional participants were enrolled.
Incidence of Study-Emergent Adverse Events. The safety/tolerability primary endpoint will be assessed comparing Grade 3 and 4 adverse events between the Active (DBS-ON) and Sham (DBS-OFF) arms throughout Phase IV (Outpatient Week 12). We will also categorize adverse events by organ system and assess relatedness to any aspect of this proof-of-concept study. Statistical tests will be performed at the request of the Data and Safety Monitoring Board (DSMB).
Outcome measures
| Measure |
DBS-ON Only
n=1 Participants
Titration will be based on stimulation parameters used in previous studies examining the role of DBS of the NAc in the treatment of OCD and depression as well as the parameters utilized in the initial pilot study conducted by the team. Participants receive active stimulation after surgery and throughout the remainder of the study. Deep Brain Stimulation: randomized, sham-controlled, partial crossover study investigating DBS, targeting the nucleus accumbens (NAc) and ventral internal capsule (VC), for participants with severe, treatment refractory OUD.
|
DBS-OFF, Then DBS-ON
Titration sessions will be conducted identically to the "DBS-ON" arm, the only difference is that no stimulation is delivered for the first 12 weeks (post surgery) and therefore, no actual adjustments made. At Study Week 12, stimulation is turn on and continues for the remainder of the study. Deep Brain Stimulation: randomized, sham-controlled, partial crossover study investigating DBS, targeting the nucleus accumbens (NAc) and ventral internal capsule (VC), for participants with severe, treatment refractory OUD.
|
|---|---|---|
|
Safety and Tolerability as Measured by All Adverse Events Related to DBS
Total Mild AEs
|
3 Adverse Events
|
—
|
|
Safety and Tolerability as Measured by All Adverse Events Related to DBS
Mild AE - Probably Related (Disorder)
|
1 Adverse Events
|
—
|
|
Safety and Tolerability as Measured by All Adverse Events Related to DBS
Mild AE - Unrelated
|
2 Adverse Events
|
—
|
|
Safety and Tolerability as Measured by All Adverse Events Related to DBS
Moderate AE - Unexpected
|
1 Adverse Events
|
—
|
|
Safety and Tolerability as Measured by All Adverse Events Related to DBS
Moderate AE - Probably Related (Disorder)
|
1 Adverse Events
|
—
|
|
Safety and Tolerability as Measured by All Adverse Events Related to DBS
Mild AE - Expected
|
0 Adverse Events
|
—
|
|
Safety and Tolerability as Measured by All Adverse Events Related to DBS
Mild AE - Unexpected
|
3 Adverse Events
|
—
|
|
Safety and Tolerability as Measured by All Adverse Events Related to DBS
Total Moderate AEs
|
1 Adverse Events
|
—
|
|
Safety and Tolerability as Measured by All Adverse Events Related to DBS
Moderate AE - Expected
|
0 Adverse Events
|
—
|
PRIMARY outcome
Timeframe: Outpatient Week 12Population: Only one participant enrolled in the study; assigned to the DBS-ON arm. No additional participants were enrolled.
Opioid use will be evaluated through the use of quantitative urine toxicology using gas chromatography/mass spectrometry. The primary outcome comparison between the active and sham arms will be based off participants with undetectable opioid metabolites (assessed via quantitative urine toxicology) throughout the primary Outpatient Week 12 endpoint.
Outcome measures
| Measure |
DBS-ON Only
n=1 Participants
Titration will be based on stimulation parameters used in previous studies examining the role of DBS of the NAc in the treatment of OCD and depression as well as the parameters utilized in the initial pilot study conducted by the team. Participants receive active stimulation after surgery and throughout the remainder of the study. Deep Brain Stimulation: randomized, sham-controlled, partial crossover study investigating DBS, targeting the nucleus accumbens (NAc) and ventral internal capsule (VC), for participants with severe, treatment refractory OUD.
|
DBS-OFF, Then DBS-ON
Titration sessions will be conducted identically to the "DBS-ON" arm, the only difference is that no stimulation is delivered for the first 12 weeks (post surgery) and therefore, no actual adjustments made. At Study Week 12, stimulation is turn on and continues for the remainder of the study. Deep Brain Stimulation: randomized, sham-controlled, partial crossover study investigating DBS, targeting the nucleus accumbens (NAc) and ventral internal capsule (VC), for participants with severe, treatment refractory OUD.
|
|---|---|---|
|
Opioid Use Assessed Via Quantitative Urine Toxicology
Number of Participant's Opioid Negative through 12 Week Endpoint
|
1 participants
|
—
|
|
Opioid Use Assessed Via Quantitative Urine Toxicology
Number of Participant's Opioid Positive through 12 Week Endpoint
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline versus Outpatient Week 12Changes in the reward circuitry via evaluating prefrontal cortex glucose metabolism (FDG PET)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline versus Outpatient Week 12Changes in the reward circuitry via evaluating dopamine in the basal ganglia and NAc (18F-fallypride PET).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline versus Outpatient Week 12Substance craving without cues: Substance craving will be assessed using a visual analog scale (VAS) where participants are asked to rate their craving. Participants will be asked "How much do you crave \[insert substance name\] right now?". Scale: 0 to 10 where 0 = no craving and 10 = maximum craving
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline versus Outpatient Week 12Substance craving with cues (via a cue reactivity task): A set of substance-related stimuli (e.g., photos, computer images) will be presented to the participant. Prior to and immediately after viewing the cues, participants will complete computer-based assessment VAS designed to assess craving. Participants will be asked "How much do you crave \[insert substance name\] right now?". Scale: 0 to 10 where 0 = no craving and 10 = maximum craving
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline versus Outpatient Week 12Mood and emotional functioning (depression and anxiety) assessed via the Comprehensive Psychopathological Rating Scale (CPRS) Scale: 0 - 108 where 0 = no distress and 108 = severe distress
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline versus Outpatient Week 12Cognitive Functioning assessed via NIH Toolbox Cognition Battery (NIHTB)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline versus Outpatient Week 12Cognitive Functioning assessed via the standard neuropsychological battery (e.g., WAIS-IV)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline versus Outpatient Week 12Cognitive Functioning assessed via the experimental measures of executive functioning (e.g., Flanker, N-Back, Psychomotor Vigilance, Delayed Discounting).
Outcome measures
Outcome data not reported
Adverse Events
DBS-ON Only
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
DBS-OFF, Then DBS-ON
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DBS-ON Only
n=1 participants at risk
Titration will be based on stimulation parameters used in previous studies examining the role of DBS of the NAc in the treatment of OCD and depression as well as the parameters utilized in the initial pilot study conducted by the team. Participants receive active stimulation after surgery and throughout the remainder of the study.
Deep Brain Stimulation: randomized, sham-controlled, partial crossover study investigating DBS, targeting the nucleus accumbens (NAc) and ventral internal capsule (VC), for participants with severe, treatment refractory OUD.
|
DBS-OFF, Then DBS-ON
Titration sessions will be conducted identically to the "DBS-ON" arm, the only difference is that no stimulation is delivered for the first 12 weeks (post surgery) and therefore, no actual adjustments made. At Study Week 12, stimulation is turn on and continues for the remainder of the study.
Deep Brain Stimulation: randomized, sham-controlled, partial crossover study investigating DBS, targeting the nucleus accumbens (NAc) and ventral internal capsule (VC), for participants with severe, treatment refractory OUD.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Dental pain
|
100.0%
1/1 • Number of events 1 • Outpatient Week 12
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
—
0/0 • Outpatient Week 12
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Musculoskeletal and connective tissue disorders
Fractured Molar (x2)
|
100.0%
1/1 • Number of events 1 • Outpatient Week 12
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
—
0/0 • Outpatient Week 12
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Cardiac disorders
Hyperkalemia
|
100.0%
1/1 • Number of events 1 • Outpatient Week 12
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
—
0/0 • Outpatient Week 12
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Cardiac disorders
Palpitations
|
100.0%
1/1 • Number of events 1 • Outpatient Week 12
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
—
0/0 • Outpatient Week 12
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Cardiac disorders
Intermittent Hypertension
|
100.0%
1/1 • Number of events 1 • Outpatient Week 12
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
—
0/0 • Outpatient Week 12
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
Additional Information
James Mahoney, PhD
WVU Rockefeller Neuroscience Institute
Phone: 304-293-5323
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place