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

Substance-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04157062
• Other study ID #: 1907653805
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: October 1, 2025

Study information

• Verified date: May 2023
• Source: West Virginia University
• Contact: James J. Mahoney, Ph.D.
• Phone: (304) 293-1822
• Email: james.mahoney[@]hsc.wvu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Repetitive 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.

Locations

Country	Name	City	State
United States	West Virginia University School of Medicine	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	week 1, week 3, and week 7
Primary	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	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).	1 - 7 weeks