Clinical trial NCT04379115: Optimization of NIBS for Treatment of Addiction
Official title: Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid-use Disorder
Chronic Pain
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: Highland Instruments, Inc.
First posted: 2020-05-07
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-center, double-blinded, placebo controlled, randomized study.
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion 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

Exclusion Criteria:

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.

Primary outcomes:
measure: Change in drug use from baseline.
timeFrame: Measured for approximately 6 weeks
Secondary outcomes:
measure: Changes in the Verbal Rating Scale (VRS) for Pain
timeFrame: Measured for approximately 6 weeks
measure: Changes in pain as measured by the Visual Analog Scale (VAS)
timeFrame: Measured for approximately 6 weeks
measure: Safety measures
timeFrame: Measured for approximately 6 weeks
measure: Study 36-Item Short Form (SF-36)
timeFrame: Measured for approximately 6 weeks
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Measured for approximately 6 weeks
measure: Electroencephalography (EEG) recording:
timeFrame: Measured for approximately 6 weeks
measure: Ultimatum Game:
timeFrame: Measured for approximately 6 weeks
measure: Risk Task:
timeFrame: Measured for approximately 6 weeks
measure: Inhibitory Control Task:
timeFrame: Measured for approximately 6 weeks
measure: Opioid Cue-Exposure Task for Craving Assessment:
timeFrame: Measured for approximately 6 weeks
measure: Hair follicle drug test
timeFrame: Measured for approximately 6 weeks
measure: National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST)
timeFrame: Measured for approximately 6 weeks
measure: Obsessive-Compulsive Drinking/Drug Use Scale (OCDS)
timeFrame: Measured for approximately 6 weeks
measure: 15-item Barrett Impulsivity scale
timeFrame: Measured for approximately 6 weeks
measure: National Institute on Drug Abuse (NIDA) Quick Screen
timeFrame: Measured for approximately 6 weeks
measure: Urine drug test
timeFrame: Measured for approximately 6 weeks
Other outcomes:
Locations:
city: Hinsdale
country: United States
facility: University of Illinois Health/ University of Illinois at Chicago
state: Illinois
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center/ Case Western Reserve University
name: Ciro R Estebanez, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: