Developing rTMS Treatment Strategies for Pain in Opiate Dependence

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Pain, Chronic Pain, Opioid Dependence, Opioid Use

In brief

The purpose of this study is to parametically evaluate two different types of repetitive Transcranial Magnetic Stimulation (rTMS) treatment strategies as a potential treatment for pain in individuals currently taking prescription opiates. Repetitive TMS is a non-invasive tool that uses magnetic pulses to temporarily stimulate specific brain areas. This study will test whether rTMS over different locations of the prefrontal cortex can produce a reduction in an individuals perception of pain and how the brain responds to pain. Participants will be randomized to receive either sham-rTMS, or one of two real rTMS treatments. Brain imaging, behavioral assessments, and pain assessments will be collected both immediately before and after rTMS.

Key facts

Study ID

NCT03576781

Run by

Medical University of South Carolina

People needed

70

Starts

2017-02-09

Expected to finish

2019-11-12

Last updated by the study team

2020-01-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to read and understand questionnaires and informed consent.
• Able to read and understand questionnaires and informed consent.
• Lives within 50 miles of the study site.
• Is not at elevated risk of seizure (i.e., does not have a history of seizures, is not currently prescribed medications known to lower seizure threshold)
• Does not have metal objects in the head/neck.
• Does not have a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or subarachnoid hemorrhage.
• Does not have a history of claustrophobia leading to significant clinical anxiety symptoms.

You may not qualify if…

• Any psychoactive illicit substance use (except marijuana and nicotine) within the last 30 days by self-report and urine drug screen. For marijuana, no use within the last seven days by verbal report and negative (or decreasing) urine THC levels.
• Meets DSM IV criteria for current axis I disorders of major depression, panic disorder, obsessive-compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders, eating disorders, and any other psychotic disorder or organic mental disorder.
• Has current suicidal ideation or homicidal ideation.
• Has the need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications and medications for ADHD.
• Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
• Has current charges pending for a violent crime (not including DUI related offenses).
• Does not have a stable living situation.
• Suffers from chronic migraines.

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States
• Ralph H Johnson Veterans Medical Center — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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