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An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder

Primary Purpose

Opioid-use Disorder, Substance-Related Disorders, Chemically-Induced Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder focused on measuring Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Able to provide written informed consent, and to comply with study procedures.
  • Be actively enrolled in the COAT Program
  • Meet DSM-V criteria for a primary OUD assessed via structured clinical interview
  • Columbia-Suicide Severity Rating Scale score < 4
  • Be abstinent from opioids (other than prescribed buprenorphine/naloxone) and illicit substances other than marijuana at the time of the enrollment, confirmed via urine drug screen
  • Willing to practice contraception to avoid pregnancy the duration of the study

Exclusion Criteria:

  • Medical conditions that preclude rTMS: including vasodepressor syncope, glaucoma, increased intracranial pressure, cardiac disease, migraine disorder, cerebral vascular events (cerebral vascular accident, transient ischemic attack), any brain lesions (such multiple sclerosis), brain injury, seizure disorder (or family history) of any type, and have cardiac pacemakers or implanted medication pumps
  • DSM-V criteria for major psychiatric illness other than depression
  • Major Cognitive Disorder (as evidenced by a score of <21/30 on the Mini Mental Status Exam (MMSE)
  • Pregnancy
  • Positive responses to the TMS Adult Safety Screen or the MRI checklist
  • Intracranial metallic objects (excluding dental fillings)
  • Uncorrected visual acuity problems
  • Mobility limitations
  • Clinically significant EKG abnormalities (including QTc interval prolongation >450 ms in men or >480 ms in women)
  • Unwillingness to abstain from prescribed drugs
  • Prior rTMS treatment
  • Other mental or physical conditions that, in the PI's opinion, would be inappropriate for study participation.

  • Intake of one or a combination of the following drugs forms a 'Strong Potential Hazard' for application of rTMS due to their significant seizure threshold lowering potential:

    • Imipramine, Amitriptyline, Doxepine, Nortriptyline, Maprotiline, Chlorpromazine, Clozapine, Foscarnet, Ganciclovir, Ritonavir, Amphetamines, Cocaine (MDMA, ecstasy), Phencyclidine (PCP, angel's dust), Ketamine, Gamma-hydroxybutyrate (GHB), Alcohol, Theophylline.
    • The inclusion of a patient on any of the above medication will be carefully evaluated and a decision documented by the medically responsible physician. The risk is dependent on the patient's past medical history, drug dose, speed of dose increase (or decrease), history of recent medication changes or duration of treatment, and combination with other CNS active drugs.

  • Recent withdrawal from one of the following drugs forms a 'Strong Relative Hazard' for application of rTMS due to the resulting significant seizure threshold lowering potential:

    • Alcohol, Barbiturates, Benzodiazepines, Meprobamate, Chloral hydrate

Sites / Locations

  • West Virginia University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Group

Arm Description

Participants will receive a type of TMS called repetitive TMS (rTMS) wherein the magnetic pulses delivered will be close together in a rapid sequence. They will receive excitatory rTMS with a stimulation frequency of 10 Hz or higher.

Outcomes

Primary Outcome Measures

rTMS reduces substance use
Opioid use as measured by quantitative urine toxicology via high pressure liquid chromatography at screening, baseline, enrollment (3 times per week for 3 weeks), and follow-up phases (weekly for 4 weeks).

Secondary Outcome Measures

rTMS applied to the DLPFC provides neuromodulatory effects
Participants will complete standardized measures of mood, drug craving, and executive function at screening, baseline, enrollment (3 times per week for 3 weeks), and follow-up phases (weekly for 4 weeks).

Full Information

First Posted
November 6, 2019
Last Updated
May 30, 2023
Sponsor
West Virginia University
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1. Study Identification

Unique Protocol Identification Number
NCT04157062
Brief Title
An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder
Official Title
An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The purpose of this study is to understand the role of repetitive Transcranial Magnetic Stimulation (rTMS) in reducing opioid and other substance use and craving and improving thinking skills.
Detailed Description
The overarching goal of this study is to investigate a form of neuromodulation, rTMS, as an adjunctive treatment for OUD by evaluating the impact of rTMS on substance use, craving and inhibitory control, factors which contribute to relapse. The primary outcome will be the assessment of whether rTMS reduces substance use. Additional exploratory outcomes include the assessment of whether rTMS applied to the DLPFC provides neuromodulatory effects through the assessment of craving, inhibitory control, and functional connectivity via MRI. The targeted sample size for this open-label study, where all enrolled subjects will receive 9 sessions of active rTMS over 3 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorder
Keywords
Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is an open-label study for participants who have opioid use disorder (OUD) that are eligible to have repetitive transcranial magnetic stimulation (rTMS) targeting the left dorsolateral prefrontal cortex (DLPFC).
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
Participants will receive a type of TMS called repetitive TMS (rTMS) wherein the magnetic pulses delivered will be close together in a rapid sequence. They will receive excitatory rTMS with a stimulation frequency of 10 Hz or higher.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
During the rTMS session, an electromagnetic coil is placed against the subjects scalp. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in memory and thinking.
Primary Outcome Measure Information:
Title
rTMS reduces substance use
Description
Opioid use as measured by quantitative urine toxicology via high pressure liquid chromatography at screening, baseline, enrollment (3 times per week for 3 weeks), and follow-up phases (weekly for 4 weeks).
Time Frame
1 - 7 weeks
Secondary Outcome Measure Information:
Title
rTMS applied to the DLPFC provides neuromodulatory effects
Description
Participants will complete standardized measures of mood, drug craving, and executive function at screening, baseline, enrollment (3 times per week for 3 weeks), and follow-up phases (weekly for 4 weeks).
Time Frame
1 - 7 weeks
Other Pre-specified Outcome Measures:
Title
Functional connectivity changes
Description
Measure by MRI scans prior to and following the first rTMS session, following the final rTMS session, and during the final follow-up.
Time Frame
week 1, week 3, and week 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to provide written informed consent, and to comply with study procedures. Be actively enrolled in the COAT Program Meet DSM-V criteria for a primary OUD assessed via structured clinical interview Columbia-Suicide Severity Rating Scale score < 4 Be abstinent from opioids (other than prescribed buprenorphine/naloxone) and illicit substances other than marijuana at the time of the enrollment, confirmed via urine drug screen Willing to practice contraception to avoid pregnancy the duration of the study Exclusion Criteria: Medical conditions that preclude rTMS: including vasodepressor syncope, glaucoma, increased intracranial pressure, cardiac disease, migraine disorder, cerebral vascular events (cerebral vascular accident, transient ischemic attack), any brain lesions (such multiple sclerosis), brain injury, seizure disorder (or family history) of any type, and have cardiac pacemakers or implanted medication pumps DSM-V criteria for major psychiatric illness other than depression Major Cognitive Disorder (as evidenced by a score of <21/30 on the Mini Mental Status Exam (MMSE) Pregnancy Positive responses to the TMS Adult Safety Screen or the MRI checklist Intracranial metallic objects (excluding dental fillings) Uncorrected visual acuity problems Mobility limitations Clinically significant EKG abnormalities (including QTc interval prolongation >450 ms in men or >480 ms in women) Unwillingness to abstain from prescribed drugs Prior rTMS treatment Other mental or physical conditions that, in the PI's opinion, would be inappropriate for study participation. Intake of one or a combination of the following drugs forms a 'Strong Potential Hazard' for application of rTMS due to their significant seizure threshold lowering potential: Imipramine, Amitriptyline, Doxepine, Nortriptyline, Maprotiline, Chlorpromazine, Clozapine, Foscarnet, Ganciclovir, Ritonavir, Amphetamines, Cocaine (MDMA, ecstasy), Phencyclidine (PCP, angel's dust), Ketamine, Gamma-hydroxybutyrate (GHB), Alcohol, Theophylline. The inclusion of a patient on any of the above medication will be carefully evaluated and a decision documented by the medically responsible physician. The risk is dependent on the patient's past medical history, drug dose, speed of dose increase (or decrease), history of recent medication changes or duration of treatment, and combination with other CNS active drugs. Recent withdrawal from one of the following drugs forms a 'Strong Relative Hazard' for application of rTMS due to the resulting significant seizure threshold lowering potential: Alcohol, Barbiturates, Benzodiazepines, Meprobamate, Chloral hydrate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James J. Mahoney, Ph.D.
Phone
(304) 293-1822
Email
james.mahoney@hsc.wvu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Padma Tirumalai
Phone
3042934999
Email
ptirumalai@hsc.wvu.edu
Facility Information:
Facility Name
West Virginia University School of Medicine
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Marton, BS
Phone
304-293-5293
Email
jennifer.marton@hsc.wvu.edu

12. IPD Sharing Statement

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An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder

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