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WithdrawnNCT04157062Updated Apr 10, 2025

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

An interventional study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Opioid-use Disorder, Substance-Related Disorders and Chemically-Induced Disorders, sponsored by West Virginia University. Withdrawn. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-04-10.

Sponsored by West Virginia University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Research never commenced.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Opioid-use Disorder
  • Substance-Related Disorders
  • Chemically-Induced Disorders
  • Mental Disorder

Keywords

  • Transcranial Magnetic Stimulation
03

In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

Browse Opioid-Related Disorders studies →

Lead sponsor

West Virginia University is the lead sponsor of 155 studies on the registry; 35 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Study Group

    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.

    Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

  • DeviceRepetitive Transcranial Magnetic Stimulation (rTMS)

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 1 - 7 weeks

Secondary outcomes

  1. 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).

    Time frame: 1 - 7 weeks

Other outcomes

  1. Functional connectivity changes

    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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04157062
Lead sponsor
West Virginia University
Responsible party
James Mahoney (Assistant Professor/Clinical Neuropsychologist, West Virginia University) — Principal investigator
First posted
Nov 8, 2019
Start date
Sep 30, 2021 (estimated)
Primary completion
Mar 19, 2025
Completion
Mar 19, 2025
Last update
Apr 10, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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