Optimization of NIBS for Treatment of Addiction

Case Western Reserve University

Status: Enrolling

Conditions: Opioid-use Disorder; Chronic Pain

Treatments: Device: Active Comparator: Active tDCS + Active TUS; Device: Sham Comparator: Sham tDCS + Sham TUS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04379115

STUDY20190760

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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
• Reside locally with no plans to relocate during the study Exclusion Criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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126 participants in 2 patient groups

Active (tDCS) + Active TUS

Active Comparator group

Description:

Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS)

Treatment:

Device: Active Comparator: Active tDCS + Active TUS

Sham (tDCS) + Sham TUS

Sham Comparator group

Description:

Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).

Treatment:

Device: Sham Comparator: Sham tDCS + Sham TUS