RecruitingNot ApplicableNCT04379115

Optimization of NIBS for Treatment of Addiction

Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction

Sponsor

Case Western Reserve University

Enrollment

126 participants

Start Date

Apr 4, 2021

Study Type

INTERVENTIONAL

Conditions

Chronic Pain Opioid-use Disorder

Summary

The purpose of this study is to assess the effects of transcranial Direct Current Stimulation (tDCS) applied in conjunction with Transcranial Ultrasound (TUS) for the treatment of addiction in opiate use disorder with chronic pain. The investigators hypothesize that there will be a decrease in drug use and improved psychosocial assessments with active stimulation, when compared to sham stimulation.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria7

Participants must meet all of the following:
Provide informed consent
Age 18-85 years
Diagnosis of opioid use disorder (DSM-5) with ongoing non-prescription opioid use confirmed by self-report and urine toxicology
Report current opioid craving
Enrolled in a certified Opioid Treatment Program and receiving methadone maintenance treatment
Stable methadone dose prior to enrollment

Exclusion Criteria9

Participants will be excluded if they:
Are pregnant
Have frequent illicit stimulant use or acute stimulant intoxication
Are using substances or medications that may interfere with study assessments (e.g., stimulant medications, buprenorphine-based therapies, naltrexone)
Have significant neurological conditions (e.g., stroke, epilepsy, brain tumor), abnormal EEG findings, history of brain surgery, significant head injury, or unexplained syncope
Have contraindications to noninvasive brain stimulation (e.g., metal in the head, implanted brain devices)
Have moderate to severe depression or active suicidal ideation/behavior
Have active malignancy
Consume substances that could confound opioid toxicology results (e.g., poppy-seed products)

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEActive Comparator: Active tDCS + Active TUS

Device: Active comparator device: Active transcranial Direct Current Stimulation (tDCS). Subjects will receive 20 minutes of active tDCS. During each Active stimulation session, stimulation will be applied for the full 20 minutes. Device: Active comparator device: Active Transcranial Ultrasound (TUS). Subjects will receive 20 minutes of active Transcranial Ultrasound (TUS). During active stimulation the (TUS) will be active for the full 20 minutes.

DEVICESham Comparator: Sham tDCS + Sham TUS

Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of sham tDCS. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of sham TUS. During sham stimulation the ultrasound will not be active for the full 20 minutes.