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Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
Illinois
University of Illinois Health/ University of Illinois at Chicago
RECRUITING
Hinsdale
Massachusetts
Spaulding Rehabilitation Hospital - 5th Floor - Neuromodulation Center
RECRUITING
Cambridge
Ohio
University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit
RECRUITING
Cleveland
Contact Information
Primary
Kimberly Bass, RN
kimberly.bass@uhhospitals.org
216-286-7250
Backup
Mario Becerra, RN
Mario.Becerra@UHHospitals.org
216-844-1734
Time Frame
Start Date: 2021-04-04
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 126
Treatments
Active_comparator: Active (tDCS) + Active TUS
Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS)
Sham_comparator: Sham (tDCS) + Sham TUS
Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
Authors
Ciro Ramos Estebanez
Related Therapeutic Areas
Sponsors
Collaborators: Highland Instruments, Inc.
Leads: Case Western Reserve University

This content was sourced from clinicaltrials.gov