Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction

Status: Recruiting
Location: See all (2) 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:

• Providing informed consent to participate in the study.

• 18 to 85 years old.

• Having a diagnosis of OUD, in the setting of CP:

‣ OUD of more than 6 months duration as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5) \[64\] and a positive urine toxicology screen.

⁃ or OUD patients who still feel craving or have not received more than 60 mg of methadone/day from the Methadone program.

• Lives in the immediate area with no plans to relocate

Locations
United States
Illinois
University of Illinois Health/ University of Illinois at Chicago
RECRUITING
Hinsdale
Ohio
University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit
RECRUITING
Cleveland
Contact Information
Primary
Megan Miller
megan.miller3@uhhospitals.org
216-844-4720
Backup
Kimberly Bright
kimberly.Bright@uhhospitals.org
(216) 844-0474
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