PET/MRI Study on the Neurological Mechanism of rTMS Treatment for Heroin Addiction

Relapse Clinical Trial

Official title:

PET/MRI Study on the Neurological Mechanism of rTMS Treatment for Heroin Addiction by Stimulating Left Dorsolateral Prefrontal Cortex

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04086459
• Other study ID #: Addiction-No.1
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: January 2021
• Source: Tang-Du Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavior, Addictive
• Heroin Addiction
• Heroin Dependence
• Relapse

Intervention

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)

Locations

Country	Name	City	State
China	Tangdu Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of craving	Craving scores will be assessed with visual analogue scale	Baseline, 1 week later, 1,2,3,4,5,6 months later
Primary	Change of protracted-abstinence symptoms	Protracted-abstinence symptoms scores will be assessed with protracted symptoms questionnaire	Baseline, 1 week later, 1,2,3,4,5,6 months later
Primary	Change of depress symptoms	Depress symptoms scores will be assessed with Beck Depression Inventory	Baseline, 1 week later, 1,2,3,4,5,6 months later
Primary	Change of anxiety symptoms	Anxiety symptoms scores will be assessed with Hamilton Anxiety Scale	Baseline, 1 week later, 1,2,3,4,5,6 months later
Primary	Change of impulsive behaviors	Impulsive behaviors scores will be assessed with Barratt impulsiveness scale	Baseline, 1 week later, 1,2,3,4,5,6 months later
Primary	Change of sleep	Sleep scores will be assessed with Pittsburgh sleep quality index	Baseline, 1 week later, 1,2,3,4,5,6 months later
Primary	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	Baseline, 1 week later, 1,3,6 months later
Primary	Change of gray matter volume of whole brain	Gray matter volume will be measured with magnetic resonance imaging (high resolution T1-weighted image)	Baseline, 1 week later, 1,3,6 months later
Primary	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)	Baseline, 1 week later, 1,3,6 months later
Primary	Change of availability of dopamine 2 receptor of whole brain	Accumulation of 11C-raclopride will be analyzed by time-related Positron emission tomography	Baseline, 1 month later
Primary	Change of metabolism of glucose in the brain	Accumulation of 18F-FDG will be analyzed by time-related Positron emission tomography	Baseline, 1 month later