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

NCT04157062 | Withdrawn FDA Device

• 1 other identifier: 1907653805
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Transcranial Magnetic Stimulation

Outcome Measures

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).

  1 - 7 weeks

Secondary Outcomes (1)

• rTMS applied to the DLPFC provides neuromodulatory effects

  1 - 7 weeks

Other Outcomes (1)

• Functional connectivity changes

  week 1, week 3, and week 7

Study Arms (1)

Study Group

EXPERIMENTAL

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

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

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.

Study Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• West Virginia University: lead

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor/Clinical Neuropsychologist

Model Details: 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).

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: September 30, 2021
• Primary Completion: March 19, 2025
• Study Completion: March 19, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-03