Heroin Dependence Clinical Trial
Official title:
The Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Opioid Use Disorders: Analysis of Clinical Outcomes, Functional Magnetic Resonance Imaging, Biomarkers, and Neuropsychological Tests
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.
n/a
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