Optimization of NIBS for Treatment of Addiction

Not Applicable

Recruiting

• Conditions: Chronic Pain; Opioid-use Disorder

• Registration Number: NCT04379115
• Lead Sponsor: Case Western Reserve University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-07
• Study Start: 2021-04-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in drug use from baseline.	Measured for approximately 6 weeks	American Pain Foundation Pain/Medication Diary is used to monitor Drug Use overtime after stimulation for approximately 6 weeks.

Secondary Outcome Measures

Name	Time	Method
Opioid Cue-Exposure Task for Craving Assessment:	Measured for approximately 6 weeks	A set of randomized videos showing scenes of people using opioids will aid assessment of craving.
Obsessive-Compulsive Drinking/Drug Use Scale (OCDS)	Measured for approximately 6 weeks	This measure reflects obsessionality and compulsivity related to craving and drinking behavior with a total score ranging from 0 to 64 (with 64 being the worst).
15-item Barrett Impulsivity scale	Measured for approximately 6 weeks	15-item Barrett Impulsivity scale is used to measure impulsivity with a total score ranging from 15 to 60 (with 15 lower level of impulsivity and 60 higher levels of impulsivity.
Changes in pain as measured by the Visual Analog Scale (VAS)	Measured for approximately 6 weeks	Changes in VAS for Pain will be measured in order to determine if tDCS + ESSTIM is effective in reducing the pain of subjects with Chronic Pain (CP) and Opioid Use Disorder(OUD) when compared to the SHAM group.Visual Analog Scale (VAS) for Pain will assess a patient's pain intensity on a scale from 0 (no pain) to 10 (worst pain imaginable).
Safety measures	Measured for approximately 6 weeks	The investigators will measure safety through a standardized neurological exam, which will include the assessment of cognitive domains including memory, attention, mood (scaled as normal or abnormal).
Study 36-Item Short Form (SF-36)	Measured for approximately 6 weeks	This is a health survey using a scale from 0 (worst) to 100 (best)
Ultimatum Game:	Measured for approximately 6 weeks	This task evaluates reward, salience and executive network behavioral correlates
National Institute on Drug Abuse (NIDA) Quick Screen	Measured for approximately 6 weeks	The NIDA Quick Screen is a validated instrument designed to assist providers in screening adults for substance use which has a yes/no scale (with "no" being best and "yes" being worse)
Patient Health Questionnaire (PHQ-9)	Measured for approximately 6 weeks	This questionnaire screens for depression with a score of 0 (best) to 27 (worst)
Inhibitory Control Task:	Measured for approximately 6 weeks	We will assess the interaction between reward processing (via the presence or absence of reward) and mechanisms of inhibitory control.
National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST)	Measured for approximately 6 weeks	Clinician's Screening Tool for Drug Use in General Medical Settings which implements a scale from 0-3 "Low Risk", 3-26 " Moderate Risk", and 27+ "High Risk"
Urine drug test	Measured for approximately 6 weeks	A Urine drug test screens for illicit drug use and the misuse of prescription medication. The sample is then analyzed for signs of drug use during the past few days. The results will be measured as positive or negative.
Electroencephalography (EEG) recording:	Measured for approximately 6 weeks	previous: EEG recording: On the first baseline visit, on the first day of Week 1, at the end of each stimulation week, and at the follow up visits. EEG recordings will be taken to monitor changes in power in different frequency bands including (theta, alpha, beta and gamma) for 20 min.
Hair follicle drug test	Measured for approximately 6 weeks	A hair follicle drug test screens for illicit drug use and the misuse of prescription medication. The sample is then analyzed for signs of drug use over 90 days. The results will be measured as positive or negative.
Changes in the Verbal Rating Scale (VRS) for Pain	Measured for approximately 6 weeks	Changes in VRS for Pain will be measured in order to determine if tDCS + ESSTIM is effective in reducing the pain of subjects with Chronic Pain (CP) and Opioid Use Disorder(OUD) when compared to the SHAM group.Verbal Rating Scale (VRS) for Pain is a categorical scale of pain with categories: none, mild, moderate, severe pain intensity.
Risk Task:	Measured for approximately 6 weeks	The task is designed to analyze the relationship between prediction and reward (and penalty) is associated with the choice of the least likely outcome, and the smallest reward (and penalty).

Trial Locations

Locations (2)

University of Illinois Health/ University of Illinois at Chicago; 🇺🇸 Hinsdale, Illinois, United States

University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit; 🇺🇸 Cleveland, Ohio, United States