Repetitive Transcranial Magnetic Stimulation in Patients With Opioid Use

Status Recruiting

Clinical Trial Summary

Opioid use disorder (OUD) is prevalent and causes substantial health and social burdens. Although evidence have showed the effectiveness of opioid agonist maintenance therapy in OUD, high drop-out rate and the requirement of continuing use of opioid agonists are the major problems. Therefore, to develop novel treatment for OUD is important.

Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive method of brain stimulation used to treat a variety of neuropsychiatric disorders. Recent studies showed that there may be potential therapeutic effects in rTMS for addictive disorder, including reducing craving and substance use severity. The underlying mechanisms of rTMS in treating addictions may involve increased dopamine function in corticomesolimbic brain circuits and modulation of neural activity in brain circuits that relevant to addiction. However, the treatment results of rTMS in OUD were lacked, and the analysis in functional brain imaging study, neuropsychological tests and other potential biomarkers under rTMS treatment were limited, too.

Thus, the investigators will conduct the add-on double-blinded, sham-controlled study rTMS treatment in 40-60 patients with OUD under methadone maintenance therapy. Patients will be allocated to active and sham rTMS in a 1 : 1 ratio, and participants will receive rTMS on the left dorsolateral prefrontal cortex (DLPFC) (15 Hz frequency, 4 seconds per train, inter-train interval of 26 seconds, 40 trains per session, total 11 sessions in 4 weeks). The treatment response, urine drug tests, craving scales and side effects to evaluate the therapeutic effects of rTMS will be examined. Neuropsychological assessments, functional magnetic resonance imaging (fMRI) and tests for potential biomarkers of immune parameters will also be measured during 12-weeks follow up. The study results will provide the important data in whether rTMS add-on methadone maintenance therapy is able to 1) reduce heroin use; 2) reduce craving for heroin; 3) be an effective treatment for OUD, and 4) be associated with improvement in fMRI, biological markers and psychological tests.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Heroin Dependence
Transcranial Magnetic Stimulation

Clinical Trial Details

NCT number	NCT03229642
Study type	Interventional
Source	National Cheng-Kung University Hospital
Contact	Tzu-Yun Wang
Phone	+886-6-2353535
Email	tzuyun0105@hotmail.com
Status	Recruiting
Phase	N/A
Start date	August 1, 2017
Completion date	December 31, 2022

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04927364` - Examining the Effectiveness of Deep TMS in Veterans With Alcohol Use Disorder	N/A
Recruiting	`NCT06193278` - Individual Neuromodulation for PDS	N/A
Recruiting	`NCT05973019` - rTMS Improves Functions in Spinocerebellar Ataxia	N/A
Completed	`NCT05074524` - Repetitive Transcranial Magnetic Stimulation to Reduce Heroin Cravings	N/A
Recruiting	`NCT05889117` - Brain Stimulation for Concussion	N/A
Recruiting	`NCT03974659` - Enhanced Recovery After Surgery Using TMS on Cerebellar Language Area for Brain Tumor Patients	N/A
Recruiting	`NCT05613686` - Theta Burst Stimulation for Motor Recovery	N/A
Completed	`NCT04014491` - The Effects of Exercise Training on Corticospinal System in Overhead Athletes With Shoulder Impingement Syndrome	N/A
Recruiting	`NCT05914038` - Individualized rTMS for Motor Recovery in Stroke Patients	N/A
Recruiting	`NCT06084455` - TMS-evoked Potentials During Aerobic Exercise	N/A
Completed	`NCT05566444` - TMS-evoked Potentials During Heat Pain	N/A
Enrolling by invitation	`NCT04313530` - TMS Treatment in Multiple System Atrophy With Fatigue	N/A
Completed	`NCT04209309` - Repetitive Transcranial Magnetic Stimulation as a Potential Tool to Reduce Sexual Arousal	N/A
Terminated	`NCT04486222` - Accelerated Bilateral rTMS on Geriatric Depression	N/A
Recruiting	`NCT05192759` - Effect of Theta-Burst Transcranial Magnetic Stimulation (TBS) for Freezing of Gait	N/A
Recruiting	`NCT05467657` - Transcranial Magnetic Stimulation on Somtosensory Cortex Enhances Motor Learning in People With Stroke	N/A
Recruiting	`NCT05896332` - rTMS in Older Adults With MCI and AUD	Phase 1
Recruiting	`NCT04727177` - Precision-targeted Transcranial Magnetic Stimulation in the Treatment of Primary Dystonia	Early Phase 1
Recruiting	`NCT04906603` - Theta Burst Stimulation for Headaches After Traumatic Brain Injury	N/A
Recruiting	`NCT03590327` - Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Repetitive Transcranial Magnetic Stimulation in Patients With Opioid Use Disorders

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms