Substance Use Disorder (SUD)aDBS OUDNCT07214467
Individualized Adaptive Deep Brain Stimulation in Opioid Use Disorder
A study testing Deep Brain Stimulation in people with Substance Use Disorder (SUD) and Opioid Use Disorder (OUD), run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Substance Use Disorder (SUD), Opioid Use Disorder (OUD)
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2025to 22 Nov 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 taking a first-line medication for OUD (MOUD) such as buprenorphine, methadone, or extended-release naltrexone. Treatment failure is defined as continued opioid use or relapse during or after completion of treatment. Sustained remission is defined per DSM-5 as not meeting any OUD criteria except craving for > 12 months. Documented adherence: participants must have documented adherence to the failed first-line MOUD for at least 8 weeks (PMID: 29083570).
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- 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, monitor the subject's behavior, support, and encourage the subject to participate in follow-up visits and evaluations.
- 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.
Who cannot join
- 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.
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- 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 coagulopathy.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Catherine Borror, BS, 415-514-6551, TN2Lab@ucsf.edu
Sierra Brandts, BS, 415-514-6551, TN2Lab@ucsf.edu
About this study
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.
Read the detailed description
This study will enroll individuals with severe Opioid Use Disorder (OUD) who have not responded to standard treatments. The devices used in this study are investigational, which means they are not approved by the Food and Drug Administration (FDA) to treat OUD. The information we obtain in this study will be used to better understand the mechanisms of OUD in the brain.
- Being tested
- Deep Brain Stimulation
- Keywords
- Opioid, SUD, OUD, Substance Use, Substance Use Disorder, Addiction, Opioid Use Disorder, Opioid Use, deep brain stimulation, Neuromodulation, stereo-EEG, brain mapping
- Medical subject headings
- Substance-Related Disorders, Opioid-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
Also called DBS
An individualized aDBS protocol will be used to examine therapeutic effect.
| Study group | Role | What they receive |
|---|---|---|
| aDBS / cDBS / sham Stimulation | Other | Participants in this group will first receive adaptive deep brain stimulation (aDBS), followed by continuous deep brain stimulation (cDBS), and finally a sham stimulation. Each period of the randomized controlled trial (aDBS, cDBS, and sham) will last 4 months. Receives: Device: Deep Brain Stimulation |
| sham / aDBS / cDBS | Other | Participants in this group will first receive sham stimulation, followed by adaptive deep brain stimulation (aDBS), and finally continuous deep brain stimulation (cDBS). Each period of the randomized controlled trial (aDBS, cDBS, and sham) will last 4 months. Receives: Device: Deep Brain Stimulation |
| cDBS / sham / aDBS | Other | Participants in this group will first receive continuous deep brain stimulation (cDBS), followed by sham stimulation, and finally adaptive deep brain stimulation (aDBS). Each period of the randomized controlled trial (aDBS, cDBS, and sham) will last 4 months. Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events during sEEG phase
To assess the safety of sEEG mapping in patients with severe and refractory OUD.
Measured: Up to 2 weeks during sEEG phase.
Incidence of adverse events during aDBS phase
To assess the safety of aDBS in patients with severe and refractory OUD.
Measured: Up to 16 months from time of DBS implantation.
Secondary outcomes (3)
sEEG Mapping: Brain mapping
To identify individualized brain targets for sensing neural biomarkers of craving and stimulation to mitigate craving.
Measured: Up to 2 weeks during sEEG phase.
Opioid use duirng aDBS treatment
To evaluate the preliminary efficacy of individualized aDBS in patients with severe and refractory OUD by measuring the effects of aDBS on opioid use measured with TLFB.
Measured: Up to 16 months from time of DBS implantation.
Overall functioning duirng aDBS treatment
To evaluate the preliminary efficacy of individualized aDBS in patients with severe and refractory OUD by measuring the effects of aDBS on quality of life measured with SF-36.
Measured: Up to 16 months from time of DBS implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start24 Oct 2025
- Primary completion22 Nov 2031 (estimated)
- Study completion22 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, double-blind, sham controlled Latin square design, followed by open label follow up period pilot trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Moussawi, MD, PhD, University of California, San Francisco
- Investigators
- Khaled Moussawi, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214467
- Sponsor's protocol ID
- 25-43357
- Acronym
- aDBS OUD
- Status last verified
- Oct 2025
- First submitted
- 25 Sep 2025
- Last updated
- 28 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Zhou H, Xu J, Jiang J. Deep brain stimulation of nucleus accumbens on heroin-seeking behaviors: a case report. Biol Psychiatry. 2011 Jun 1;69(11):e41-2. doi: 10.1016/j.biopsych.2011.02.012. Epub 2011 Apr 13. No abstract available.
PubMed 21489407Chen L, Li N, Ge S, Lozano AM, Lee DJ, Yang C, Li L, Bai Q, Lu H, Wang J, Wang X, Li J, Jing J, Su M, Wei L, Wang X, Gao G. Long-term results after deep brain stimulation of nucleus accumbens and the anterior limb of the internal capsule for preventing heroin relapse: An open-label pilot study. Brain Stimul. 2019 Jan-Feb;12(1):175-183. doi: 10.1016/j.brs.2018.09.006. Epub 2018 Sep 14.
PubMed 30245163Rezai AR, Mahoney JJ, Ranjan M, Haut MW, Zheng W, Lander LR, Berry JH, Farmer DL, Marton JL, Tirumalai P, Mears A, Thompson-Lake DGY, Finomore VS, D'Haese PF, Aklin WM, George DT, Corrigan JD, Hodder SL. Safety and feasibility clinical trial of nucleus accumbens deep brain stimulation for treatment-refractory opioid use disorder. J Neurosurg. 2023 Jun 9;140(1):231-239. doi: 10.3171/2023.4.JNS23114. Print 2024 Jan 1.
PubMed 37329519Kuhn J, Moller M, Treppmann JF, Bartsch C, Lenartz D, Gruendler TO, Maarouf M, Brosig A, Barnikol UB, Klosterkotter J, Sturm V. Deep brain stimulation of the nucleus accumbens and its usefulness in severe opioid addiction. Mol Psychiatry. 2014 Feb;19(2):145-6. doi: 10.1038/mp.2012.196. Epub 2013 Jan 22. No abstract available.
PubMed 23337942
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Adaptive Deep Brain Stimulation in Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT07214467
- Acronym / sponsor ID
- aDBS OUD / 25-43357
- Keywords
- Opioid, SUD, OUD, Substance Use, Substance Use Disorder, Addiction, Opioid Use Disorder, Opioid Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 22 Nov 2031 (estimated)
- Study completion
- 22 Nov 2031 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will enroll individuals with severe Opioid Use Disorder (OUD) who have not responded to standard treatments. The devices used in this study are investigational, which means they are not approved by the Food and Drug Administration (FDA) to treat OUD. The information we obtain in this study will be used to better understand the mechanisms of OUD in the brain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a randomized, double-blind, sham controlled Latin square design, followed by open label follow up period pilot trial.
| Arm | Type | Receives |
|---|---|---|
| aDBS / cDBS / sham Stimulation | Other | Device: Deep Brain StimulationParticipants in this group will first receive adaptive deep brain stimulation (aDBS), followed by continuous deep brain stimulation (cDBS), and finally a sham stimulation. Each period of the randomized controlled trial (aDBS, cDBS, and sham) will last 4 months. |
| sham / aDBS / cDBS | Other | Device: Deep Brain StimulationParticipants in this group will first receive sham stimulation, followed by adaptive deep brain stimulation (aDBS), and finally continuous deep brain stimulation (cDBS). Each period of the randomized controlled trial (aDBS, cDBS, and sham) will last 4 months. |
| cDBS / sham / aDBS | Other | Device: Deep Brain StimulationParticipants in this group will first receive continuous deep brain stimulation (cDBS), followed by sham stimulation, and finally adaptive deep brain stimulation (aDBS). Each period of the randomized controlled trial (aDBS, cDBS, and sham) will last 4 months. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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))
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain StimulationAlso: DBSAn individualized aDBS protocol will be used to examine therapeutic effect. | Device | aDBS / cDBS / sham Stimulation, cDBS / sham / aDBS, sham / aDBS / cDBS |
Primary outcome
Incidence of adverse events during sEEG phase
Time frame: Up to 2 weeks during sEEG phase.
To assess the safety of sEEG mapping in patients with severe and refractory OUD.
Incidence of adverse events during aDBS phase
Time frame: Up to 16 months from time of DBS implantation.
To assess the safety of aDBS in patients with severe and refractory OUD.
3 secondary outcomes
sEEG Mapping: Brain mapping
Time frame: Up to 2 weeks during sEEG phase.
Opioid use duirng aDBS treatment
Time frame: Up to 16 months from time of DBS implantation.
Overall functioning duirng aDBS treatment
Time frame: Up to 16 months from time of DBS implantation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Background: PubMed 21489407Zhou H, Xu J, Jiang J. Deep brain stimulation of nucleus accumbens on heroin-seeking behaviors: a case report. Biol Psychiatry. 2011 Jun 1;69(11):e41-2. doi: 10.1016/j.biopsych.2011.02.012. Epub 2011 Apr 13. No abstract available.
- Background: PubMed 30245163Chen L, Li N, Ge S, Lozano AM, Lee DJ, Yang C, Li L, Bai Q, Lu H, Wang J, Wang X, Li J, Jing J, Su M, Wei L, Wang X, Gao G. Long-term results after deep brain stimulation of nucleus accumbens and the anterior limb of the internal capsule for preventing heroin relapse: An open-label pilot study. Brain Stimul. 2019 Jan-Feb;12(1):175-183. doi: 10.1016/j.brs.2018.09.006. Epub 2018 Sep 14.
- Background: PubMed 37329519Rezai AR, Mahoney JJ, Ranjan M, Haut MW, Zheng W, Lander LR, Berry JH, Farmer DL, Marton JL, Tirumalai P, Mears A, Thompson-Lake DGY, Finomore VS, D'Haese PF, Aklin WM, George DT, Corrigan JD, Hodder SL. Safety and feasibility clinical trial of nucleus accumbens deep brain stimulation for treatment-refractory opioid use disorder. J Neurosurg. 2023 Jun 9;140(1):231-239. doi: 10.3171/2023.4.JNS23114. Print 2024 Jan 1.
- Background: PubMed 23337942Kuhn J, Moller M, Treppmann JF, Bartsch C, Lenartz D, Gruendler TO, Maarouf M, Brosig A, Barnikol UB, Klosterkotter J, Sturm V. Deep brain stimulation of the nucleus accumbens and its usefulness in severe opioid addiction. Mol Psychiatry. 2014 Feb;19(2):145-6. doi: 10.1038/mp.2012.196. Epub 2013 Jan 22. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Khaled Moussawi, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Substance Use Disorder (SUD) and Opioid Use Disorder (OUD), run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Borror, BS (415-514-6551, TN2Lab@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events during sEEG phase (time frame: Up to 2 weeks during sEEG phase.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07214467, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025; AzTrials last refreshed its copy on 31 Oct 2026.