RECRUITING

Optimization of NIBS for Treatment of Addiction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction

Quick Facts

Study Start:2021-04-04

Study Completion:2025-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04379115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Providing informed consent to participate in the study. 2. 18 to 85 years old. 3. 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. 4. Lives in the immediate area with no plans to relocate	1. The subject is pregnant. 2. Recently started on antiepileptic drug therapy. 3. History of illegal stimulant use as demonstrated by urine toxicology. 4. . Ingestion of poppy seeds or herbal teas containing Papaveris Fructus (may cause a positive opiate test for morphine, codeine \[66, 67\]). 5. History of neurological disorders involving stroke, brain tumors, or epilepsy as self- reported (note patients will also be evaluated via electroencephalography (EEG) at baseline 1 week prior to stimulation and any patient showing abnormal EEG activity will be removed)). 6. History of unexplained fainting spells as self-reported. 7. History of head injury resulting in more than a momentary loss of consciousness as self-reported. 8. History of brain surgery as self-reported. 9. Contraindications to tDCS applied in conjunction with TUS: * Metal in the head, or * Implanted brain medical devices. 10. Suffering from severe depression (with a score of \>30 in the Beck Depression Inventory (BDI), PHQ-9≥10). 11. Active malignancy. 12. History of suicidal behavior or suicide attempts.

Inclusion Criteria

Exclusion Criteria

1. Providing informed consent to participate in the study.
2. 18 to 85 years old.
3. 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.
4. Lives in the immediate area with no plans to relocate

1. The subject is pregnant.
2. Recently started on antiepileptic drug therapy.
3. History of illegal stimulant use as demonstrated by urine toxicology.
4. . Ingestion of poppy seeds or herbal teas containing Papaveris Fructus (may cause a positive opiate test for morphine, codeine \[66, 67\]).
5. History of neurological disorders involving stroke, brain tumors, or epilepsy as self- reported (note patients will also be evaluated via electroencephalography (EEG) at baseline 1 week prior to stimulation and any patient showing abnormal EEG activity will be removed)).
6. History of unexplained fainting spells as self-reported.
7. History of head injury resulting in more than a momentary loss of consciousness as self-reported.
8. History of brain surgery as self-reported.
9. Contraindications to tDCS applied in conjunction with TUS:
* Metal in the head, or
* Implanted brain medical devices.
10. Suffering from severe depression (with a score of \>30 in the Beck Depression Inventory (BDI), PHQ-9≥10).
11. Active malignancy.
12. History of suicidal behavior or suicide attempts.

Contacts and Locations

Study Contact

Megan Miller

CONTACT

216-844-4720

megan.miller3@uhhospitals.org

Kimberly Bright

CONTACT

(216) 844-0474

kimberly.Bright@uhhospitals.org

Principal Investigator

Ciro R Estebanez, MD PhD

PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center/ Case Western Reserve University

Study Locations (Sites)

University of Illinois Health/ University of Illinois at Chicago

Hinsdale, Illinois, 60612

United States

University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit

Cleveland, Ohio, 44106-1716

United States

Collaborators and Investigators

Sponsor: Case Western Reserve University

Ciro R Estebanez, MD PhD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center/ Case Western Reserve University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-04

Study Completion Date2025-10-31

Study Record Updates

Study Start Date2021-04-04

Study Completion Date2025-10-31

Terms related to this study

Additional Relevant MeSH Terms

Opioid-use Disorder
Chronic Pain