Clinical trial NCT04086459: PET/MRI Study on the Neurological Mechanism of rTMS Treatment for Heroin Addiction
Official title: PET/MRI Study on the Neurological Mechanism of rTMS Treatment for Heroin Addiction by Stimulating Left Dorsolateral Prefrontal Cortex
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heroin Addiction
Relapse
Keywords: Repetitive transcranial magnetic stimulation
Functional magnetic resonance imaging
Positron emission tomography
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups (two groups of heroin addiction during methadone maintenance treatment and one healthy control group) were included in this study design. One heroin addiction group was administered active repetitive transcranial magnetic stimulation (rTMS) while another heroin addiction group was administered sham. The healthy control group was not given rTMS, just as control.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria for Heroin-dependent Participants:

* Clinical diagnosis of heroin addiction
* Have been receiving treatment in a methadone maintenance treatment program for no less than 6 months
* have been on a stable dose for at least 1 month before entering the study
* Right-handed

Inclusion Criteria for Healthy Control Participants:

* Clinical diagnosis of Healthy Control
* Right-handed

Exclusion Criteria for all Participants:

* Current or past psychiatric illness other than heroin and nicotine dependence
* Neurological signs and/or history of neurological disease
* History of head trauma
* History of cardiovascular or endocrine disease
* Current medical illness or recent medicine use
* Presence of magnetically active objects in the body
* Claustrophobia or any other medical condition that would preclude the participant from lying in the PET/MRI scanner for approximately 40 min.

Primary outcomes:
measure: Change of craving
timeFrame: Baseline, 1 week later, 1,2,3,4,5,6 months later
measure: Change of protracted-abstinence symptoms
timeFrame: Baseline, 1 week later, 1,2,3,4,5,6 months later
measure: Change of depress symptoms
timeFrame: Baseline, 1 week later, 1,2,3,4,5,6 months later
measure: Change of anxiety symptoms
timeFrame: Baseline, 1 week later, 1,2,3,4,5,6 months later
measure: Change of impulsive behaviors
timeFrame: Baseline, 1 week later, 1,2,3,4,5,6 months later
measure: Change of sleep
timeFrame: Baseline, 1 week later, 1,2,3,4,5,6 months later
measure: Change of functional connectivity between dorsolateral prefrontal cortex and whole brain
timeFrame: Baseline, 1 week later, 1,3,6 months later
measure: Change of gray matter volume of whole brain
timeFrame: Baseline, 1 week later, 1,3,6 months later
measure: Change of white matter integrity of whole brain
timeFrame: Baseline, 1 week later, 1,3,6 months later
measure: Change of availability of dopamine 2 receptor of whole brain
timeFrame: Baseline, 1 month later
measure: Change of metabolism of glucose in the brain
timeFrame: Baseline, 1 month later
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
Study officials:
affiliation: Tang-Du Hospital
name: Longxiao Wei, phd
role: PRINCIPAL_INVESTIGATOR
References: