Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder

NCT03538444 | Terminated Results DMC FDA Device

• 1 other identifier: Pro00077611
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This double-blind, randomized, controlled trials will investigate the effect of accelerated, repeated transcranial magnetic stimulation on opiate craving and perceived pain .

Conditions

Opiate Dependence; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Composite Opioid Craving (Want, Resist, Crave)

  Change in cue-induced craving ratings on 10 point Likert Scales. 0=Not at all; 10=Extremely How much do you WANT TO USE \_(opiate of choice)\_ right now? HOW HARD would it be for you TO RESIST USING\_(opiate of choice)\_ right now if it was offered to you? How much do you currently crave opiates? (scores on each of those questions are summed to be between 0 and 30 with 30 being the highest (and indicating the most craving).

  Baseline and three days: Pre-assessment (day 1-prior to the first delivered rTMS treatment) compared to post assessment (AM of day4 the morning following the final of three days of rTMS)

Study Arms (2)

Active rTMS

EXPERIMENTAL

Participants will receive 18 sessions of active repetitive Transcranial Magnetic Stimulation over a period of three days. TMS consists of 3000 pulses of 10Hz stimulation applied to the left DLPFC using the beam F3 method

Device: Repetitive Transcranial Magnetic Stimulation

Sham rTMS

PLACEBO COMPARATOR

Participants will receive 18 sessions of sham rTMS over a period of three days.

Device: Sham rTMS

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique which is currently FDA-approved as a treatment for major depressive disorder

Also known as: Active rTMS

Active rTMS

Sham rTMS DEVICE

Participants will undergo procedures that mimic rTMS, but that are inactive.

Sham rTMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
• Participants must meet DSM-5 criteria for moderate or severe OUD. While individuals may also meet criteria for use disorders of other substances (with the exception of alcohol or benzodiazepines), they must identify prescription opiates as their primary substance of abuse.
• Participants must be admitted to the inpatient unit for opiate detoxification.
• Participants must consent to random assignment.

You may not qualify if:

• Participants who are pregnant will be excluded.
• Participants with a history of/or current psychotic disorder will be excluded.
• Participants with a history of dementia or other cognitive impairment will be excluded.
• Participants with active suicidal ideation, or a suicide attempt within the past 90 days will be excluded.
• Participants with contraindications to receiving rTMS (including a history of seizures, or any implanted metal above the neck) will be excluded.
• Those with unstable general medical conditions will be excluded.
• Those who are currently using naltrexone, or tramadol, will be excluded.
• Those with alcohol or benzodiazepine use disorders will be excluded due to increased risk of seizure.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Gregory Sahlem MD
• Organization: Medical University of South Carolina

sahlem@musc.edu

843-792-5716

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither participants nor investigators will know whether the participant is assigned to the active or sham condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 40 individuals (20 per group) will be randomly assigned to either active or sham rTMS.

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 29, 2018
• Study Start: September 28, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: February 14, 2022
• Results First Posted: February 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)