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New treatment option for Substance Use Disorder (SUD)
Official title Individualized Adaptive Deep Brain Stimulation in Opioid Use Disorder
ClinicalTrials.gov ID: NCT07214467
What this study is testing
- What it's testing
- The purpose of this study is to determine if personalized (adaptive) Deep Brain Stimulation (DBS) based upon invasive brain mapping is safe and can lead to better outcomes like reductions in craving and opioid use.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 75
You may be able to join if
- Adults (all genders) 22 to 75 years old.
- Current diagnosis of severe primary opioid use disorder (OUD) (\>= 6 on DSM-5 OUD criteria) (any form of opioid use).
- History of opioid use for more than 5 years.
- Participants are seeking treatment for their OUD.
- Participants have insight into their opioid use disorder (score \> 26 on the recognition subscale of the Stages of Change Readiness and Treatment...
You likely can't join if
- Pregnancy or lactation.
- Non-English speaking.
- Participants are not willing to start MOUD treatment with buprenorphine or to switch MOUD to buprenorphine if they are already on other MOUD, for the...
- OUD treatment with another investigational drug or other intervention within 3 months.
- History of primary psychosis or Bipolar I disorder per the medical interview.
- History of severe personality disorder that could interfere with study participation (e.g., antisocial personality disorder) per the medical...
See the full eligibility criteria
- Adults (all genders) 22 to 75 years old.
- Current diagnosis of severe primary opioid use disorder (OUD) (\>= 6 on DSM-5 OUD criteria) (any form of opioid use).
- History of opioid use for more than 5 years.
- Participants are seeking treatment for their OUD.
- Participants have insight into their opioid use disorder (score \> 26 on the recognition subscale of the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES V.8))
- OUD is treatment refractory: unable to achieve sustained remission over the past 5 years, despite at least three treatment attempts (outpatient, residential, inpatient), with at least one treatment attempt involving...
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Social support system and stable living arrangement to provide assurances that the subject will adhere to study requirements: family or friends who live with or near the subject, and can provide collateral information...
- For individuals of reproductive potential: use of highly effective contraception for at least 4 weeks prior to sEEG surgery and agreement to use such a method during study participation.
- Pregnancy or lactation.
- Non-English speaking.
- Participants are not willing to start MOUD treatment with buprenorphine or to switch MOUD to buprenorphine if they are already on other MOUD, for the duration of the study.
- OUD treatment with another investigational drug or other intervention within 3 months.
- History of primary psychosis or Bipolar I disorder per the medical interview.
- History of severe personality disorder that could interfere with study participation (e.g., antisocial personality disorder) per the medical interview.
- History of traumatic brain injury with loss of consciousness greater than 5 minutes.
- Clinically significant cognitive impairment per neuropsychological testing.
- History of suicidal attempts in the past 3 years or current suicidal thoughts per psychiatric evaluation.
- Coagulopathy: INR \> 1.4, aPTT \> 40 s, platelets \< 100,000.
- Current clinically significant medical or neurologic disease that affects brain function (e.g., recent stroke, myocardial infarction, seizures not due to alcohol withdrawal).
- Clinically significant abnormality on structural brain MRI scan.
- Life expectancy less than 24 months per the clinical judgment of study investigators (e.g., terminal cancers).
- Any labeled DBS contraindication or inability to have brain MRI: certain pacemakers, metal in body, inability to undergo awake operation, significant cardiac or other medical risk factors for surgery, infection, and...
- Exclusion for early remission: participants who achieve early remission after initiating buprenorphine during the screening phase (prior to the sEEG phase) will be excluded from the study.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.