Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Completed NCT00577408 - Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone Phase 3
Completed NCT00218309 - Effects of Pre-Session Supplemental Hydromorphone on Drug Seeking Behavior in Opioid Dependent Individuals Phase 2
Completed NCT00000210 - Treatment Efficacy for Drug Abuse and AIDS Prevention - 1 Phase 2
Completed NCT00000211 - Treatment Efficacy for Drug Abuse and AIDS Prevention - 2 Phase 2
Completed NCT02324725 - Biomarkers of Injectable Extended Release Naltrexone Treatment Phase 4
Withdrawn NCT00000330 - Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-2 - 5 Phase 2
Completed NCT00249457 - Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 2 N/A
Completed NCT00218127 - Treatment of Opioid/Heroin Dependence: Comparison of Three Medication Dosing Regimens Phase 2
Completed NCT04133974 - Methadone Induced Memory Retrieval-extinction Procedure in Heroin Addicts N/A
Completed NCT00015288 - Buprenorphine and Naloxone Combination Study - 10 Phase 1
Terminated NCT03711318 - Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals Phase 3
Recruiting NCT02541526 - Mirtazapine as a Treatment for Co-Occurring Opioid and ATS Dependence in Malaysia Phase 3
Active, not recruiting NCT02541513 - An Open-label Study of Oral Paliparidone for the Treatment of Patients With Co-occurring Opioid and ATS Dependence Phase 3
Completed NCT01760473 - Reinforcing Effects of Intranasal (IN) Buprenorphine Versus Buprenorphine/Naloxone Phase 3
Terminated NCT01395797 - Pioglitazone for Heroin and for Nicotine Dependence Phase 1/Phase 2
Completed NCT01668706 - Pharmacogenomics Study of Sleep Disturbance and Neurocognitive Impairments in the Opioid Addicts N/A
Active, not recruiting NCT00609089 - Community Reinforcement and Family Training for Drug Abuse Treatment Retention/HIV Risk Reduction Phase 1/Phase 2
Completed NCT00684840 - Effects of Stress and Other Factors on Opiate Drug Choice. N/A
Completed NCT00759005 - Effect of Stress on Heroin-Related Memory Retrieval N/A
Completed NCT00218530 - Effectiveness of Naltrexone and Lofexidine in Treating Detoxified Heroin Addicts - 1 Phase 1