Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder (DBS OUD)
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|ClinicalTrials.gov Identifier: NCT03950492|
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : October 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Opioid-Related Disorders||Device: Deep Brain Simulator||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is an open-label, safety, tolerability, and feasibility study for participants who have treatment refractory OUD that are eligible to have deep brain stimulation (DBS) targeting the NAc/VC.|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 29, 2021|
Experimental: OUD DBS
This is a single arm study. Participants will be followed in an inpatient service for two weeks to gather baseline data followed by DBS placement and up to 6 weeks inpatient for clinical stabilization and DBS titration. All participants will then be followed twice a week for 12 weeks in the outpatient setting and then once a week for a total of 52 weeks post-titration.
Device: Deep Brain Simulator
This is an open-label, safety, tolerability, and feasibility study for participants who have treatment refractory OUD that are eligible to have DBS targeting the NAc/VC.
- Incidence of Study-Emergent Adverse Events [ Time Frame: 24 - 52 weeks ]Study participants will be closely monitored for adverse events following DBS surgery with regular check-ups by study personnel.
- Change in Opioid Use [ Time Frame: 24 - 52 weeks ]Opioid use as measured by quantitative urine toxicology via high pressure liquid chromatography.
- Participant Survival [ Time Frame: 12 -52 weeks ]Incidence of drug overdose deaths among the participants.
- Treatment Retention [ Time Frame: 12 - 52 weeks ]Participants' retention in traditional medication assisted treatment (MAT).
- Incidence of Serious Infectious Disease Complications [ Time Frame: 12 - 52 weeks ]Laboratory tests and evaluation to discern presentation of infectious disease.
- Mood, Craving and Executive Function [ Time Frame: 12 and 24 weeks post surgery ]Participants will complete standardized measures of mood, drug craving, and executive function at 12 weeks and 24 weeks post DBS titration.
- Frontal Lobe Metabolism [ Time Frame: 3 weeks and 12 weeks post surgery ]18fluoro-Deoxy-Glucose (FDG) PET will be use to determine if there is an increase in frontal lobe metabolism following DBS
- Changes in Dopamine [ Time Frame: 3 weeks and 12 weeks post surgery ]C11 Raclopride PET may be used to examine for changes in dopamine at 12 weeks post titration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950492
|Contact: Marc Haut, PhDfirstname.lastname@example.org|
|Contact: Barbara Harringemail@example.com|
|United States, West Virginia|
|West Virginia University Rockefeller Neuroscience Institute||Recruiting|
|Morgantown, West Virginia, United States, 26506|
|Contact: Marc W Haut, PhD 304-293-6276 firstname.lastname@example.org|
|Contact: Barbara Harring 304-293-9638 email@example.com|
|Principal Investigator:||Ali R Rezai, MD||West Virginia University|