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Optimization of NIBS for Treatment of Addiction

Primary Purpose

Opioid-use Disorder, Chronic Pain

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Active Comparator: Active tDCS + Active TUS

Sham Comparator: Sham tDCS + Sham TUS

About this trial

This is an interventional treatment trial for Opioid-use Disorder

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

The subject is pregnant.
Recently started on antiepileptic drug therapy.
History of illegal stimulant use as demonstrated by urine toxicology.
. Ingestion of poppy seeds or herbal teas containing Papaveris Fructus (may cause a positive opiate test for morphine, codeine [66, 67]).
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)).
History of unexplained fainting spells as self-reported.
History of head injury resulting in more than a momentary loss of consciousness as self-reported.
History of brain surgery as self-reported.
Contraindications to tDCS applied in conjunction with TUS:
- Metal in the head, or
- Implanted brain medical devices.
Suffering from severe depression (with a score of >30 in the Beck Depression Inventory (BDI), PHQ-9≥10).
Active malignancy.
History of suicidal behavior or suicide attempts.

Sites / Locations

University of Illinois Health/ University of Illinois at ChicagoRecruiting
University Hospitals Cleveland Medical Center/ Dahms Clinical Research UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active (tDCS) + Active TUS

Sham (tDCS) + Sham TUS

Arm Description

Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS)

Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).

Outcomes

Primary Outcome Measures

Change in drug use from baseline.

American Pain Foundation Pain/Medication Diary is used to monitor Drug Use overtime after stimulation for approximately 6 weeks.

Secondary Outcome Measures

Changes in the Verbal Rating Scale (VRS) for Pain

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.

Changes in pain as measured by the Visual Analog Scale (VAS)

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

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)

This is a health survey using a scale from 0 (worst) to 100 (best)

Patient Health Questionnaire (PHQ-9)

This questionnaire screens for depression with a score of 0 (best) to 27 (worst)

Electroencephalography (EEG) recording:

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.

Ultimatum Game:

This task evaluates reward, salience and executive network behavioral correlates

Risk Task:

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).

Inhibitory Control Task:

We will assess the interaction between reward processing (via the presence or absence of reward) and mechanisms of inhibitory control.

Opioid Cue-Exposure Task for Craving Assessment:

A set of randomized videos showing scenes of people using opioids will aid assessment of craving.

Hair follicle drug test

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.

National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST)

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"

Obsessive-Compulsive Drinking/Drug Use Scale (OCDS)

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

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.

National Institute on Drug Abuse (NIDA) Quick Screen

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)

Urine drug test

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.

Full Information

NCT ID

NCT04379115

First Posted

April 21, 2020

Last Updated

December 16, 2022

Sponsor

Case Western Reserve University

Collaborators

Highland Instruments, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04379115

Brief Title

Optimization of NIBS for Treatment of Addiction

Official Title

Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 18, 2020 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Case Western Reserve University

Collaborators

Highland Instruments, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-use Disorder, Chronic Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

single-center, double-blinded, placebo controlled, randomized study.

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Triple

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active (tDCS) + Active TUS

Arm Type

Active Comparator

Arm Description

Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS)

Arm Title

Sham (tDCS) + Sham TUS

Arm Type

Sham Comparator

Arm Description

Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).

Intervention Type

Device

Intervention Name(s)

Active Comparator: Active tDCS + Active TUS

Intervention Description

Device: Active comparator device: Active transcranial Direct Current Stimulation (tDCS). Subjects will receive 20 minutes of active tDCS. During each Active stimulation session, stimulation will be applied for the full 20 minutes. Device: Active comparator device: Active Transcranial Ultrasound (TUS). Subjects will receive 20 minutes of active Transcranial Ultrasound (TUS). During active stimulation the (TUS) will be active for the full 20 minutes.

Intervention Type

Device

Intervention Name(s)

Sham Comparator: Sham tDCS + Sham TUS

Intervention Description

Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of sham tDCS. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of sham TUS. During sham stimulation the ultrasound will not be active for the full 20 minutes.

Primary Outcome Measure Information:

Title

Change in drug use from baseline.

Description

American Pain Foundation Pain/Medication Diary is used to monitor Drug Use overtime after stimulation for approximately 6 weeks.

Time Frame