Individualized Adaptive Deep Brain Stimulation in Opioid Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-75
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Deep Brain Stimulation
DeviceAn individualized aDBS protocol will be used to examine therapeutic effect.
Treatment groups
6 Participants
are divided into 3 treatment groupsGroup A: aDBS / cDBS / sham StimulationOther 1 intervention
Group B: sham / aDBS / cDBSOther 1 intervention
Group C: cDBS / sham / aDBSOther 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of adverse events during sEEG phase
To assess the safety of sEEG mapping in patients with severe and refractory OUD.
Time frame
Up to 2 weeks during sEEG phase.2
Incidence of adverse events during aDBS phase
To assess the safety of aDBS in patients with severe and refractory OUD.
Time frame
Up to 16 months from time of DBS implantation.Secondary outcomes
1
sEEG Mapping: Brain mapping
To identify individualized brain targets for sensing neural biomarkers of craving and stimulation to mitigate craving.
Time frame
Up to 2 weeks during sEEG phase.2
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.
Time frame
Up to 16 months from time of DBS implantation.3
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.
Time frame
Up to 16 months from time of DBS implantation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov