An interventional study of Repetitive transcranial magnetic stimulation in Heroin Addiction and Relapse, sponsored by Tang-Du Hospital. Status unknown at 1 site in China. Open to participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-22.
Sponsored by Tang-Du Hospital · Not applicable, Interventional, and Treatment
Heroin addiction is a serious problem and the relapse rate of existing treatment methods is extremely high. Recently, international journals such as Science reported that repetitive transcranial magnetic stimulation (rTMS) can reduce the craving of addicts, alleviate depression and anxiety symptoms, and is expected to become an effective treatment. Our preliminary experiment using rTMS to stimulate the left dorsolateral prefrontal cortex of heroin addicts also showed similar effects, however, the mechanism is unclear. Previously, the investigators found that the functional connectivity between left executive control network and default mode network was negatively correlated relapse behavior, while the functional connectivity between salience network and default mode network was positively correlated with relapse behavior. Studies have shown that dopamine dysfunction in addicts and brain metabolism is the biological basis of network connectivity. It suggests that elucidating the relationship between the characteristics of large brain network connectivity and the level of dopamine receptor and relapse behavior in addicts is hopeful to further understand the neurological mechanism of rTMS treatment for addiction. In this project, the investigators intend to observe the changes of brain network connectivity, glucose metabolism and dopamine D2 receptor before and after rTMS treatment in addicts from the perspective of large brain network by combining PET/MRI with psychobehavioral approach. The relationship between rTMS and relapse behavior will be deeply analyzed to provide scientific basis for the development of effective treatment programs.
Inclusion Criteria for Heroin-dependent Participants:
Inclusion Criteria for Healthy Control Participants:
Exclusion Criteria for all Participants:
Device: Repetitive transcranial magnetic stimulation
Device: Repetitive transcranial magnetic stimulation
Those receiving experimental treatment will receive 20 sessions of rTMS, stimulation protocol included 20 sessions within 30 days (once a day, 5 days/week, 4 weeks, 10 Hz frequency, pulse intensity 100% of the resting motor threshold, 50 pulses per train, inter train pause of 10 s, 40 stimulation trains, 2000 pulses/ session)
Change of craving
Craving scores will be assessed with visual analogue scale
Time frame: Baseline, 1 week later, 1,2,3,4,5,6 months later
Change of protracted-abstinence symptoms
Protracted-abstinence symptoms scores will be assessed with protracted symptoms questionnaire
Time frame: Baseline, 1 week later, 1,2,3,4,5,6 months later
Change of depress symptoms
Depress symptoms scores will be assessed with Beck Depression Inventory
Time frame: Baseline, 1 week later, 1,2,3,4,5,6 months later
Change of anxiety symptoms
Anxiety symptoms scores will be assessed with Hamilton Anxiety Scale
Time frame: Baseline, 1 week later, 1,2,3,4,5,6 months later
Change of impulsive behaviors
Impulsive behaviors scores will be assessed with Barratt impulsiveness scale
Time frame: Baseline, 1 week later, 1,2,3,4,5,6 months later
Change of sleep
Sleep scores will be assessed with Pittsburgh sleep quality index
Time frame: Baseline, 1 week later, 1,2,3,4,5,6 months later
Change of functional connectivity between dorsolateral prefrontal cortex and whole brain
Functional connectivity based on dorsolateral prefrontal cortex will be measured with magnetic resonance imaging based on blood oxygen level dependence
Time frame: Baseline, 1 week later, 1,3,6 months later
Change of gray matter volume of whole brain
Gray matter volume will be measured with magnetic resonance imaging (high resolution T1-weighted image)
Time frame: Baseline, 1 week later, 1,3,6 months later
Change of white matter integrity of whole brain
Fractional anisotropy, axial diffusivity and radial diffusivity will be measured with magnetic resonance imaging (diffusion tensor imaging)
Time frame: Baseline, 1 week later, 1,3,6 months later
Change of availability of dopamine 2 receptor of whole brain
Accumulation of 11C-raclopride will be analyzed by time-related Positron emission tomography
Time frame: Baseline, 1 month later
Change of metabolism of glucose in the brain
Accumulation of 18F-FDG will be analyzed by time-related Positron emission tomography
Time frame: Baseline, 1 month later
Plan to share: No
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Tang-Du Hospital