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

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ClinicalTrials.gov Identifier: NCT04086459
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Tang-Du Hospital

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.

Condition or disease Intervention/treatment Phase
Heroin Addiction Relapse Device: Repetitive transcranial magnetic stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Either the participants, care providers, or outcomes assessors did not know which repetitive transcranial magnetic stimulation is active or sham.
Primary Purpose: Treatment
Official Title: PET/MRI Study on the Neurological Mechanism of rTMS Treatment for Heroin Addiction by Stimulating Left Dorsolateral Prefrontal Cortex
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heroin

Arm Intervention/treatment
Active Comparator: Active 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)

Sham Comparator: Sham 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)

No Intervention: No repetitive transcranial magnetic stimulation



Primary Outcome Measures :
  1. Change of craving [ Time Frame: Baseline, 1 week later, 1,2,3,4,5,6 months later ]
    Craving scores will be assessed with visual analogue scale

  2. Change of protracted-abstinence symptoms [ Time Frame: Baseline, 1 week later, 1,2,3,4,5,6 months later ]
    Protracted-abstinence symptoms scores will be assessed with protracted symptoms questionnaire

  3. Change of depress symptoms [ Time Frame: Baseline, 1 week later, 1,2,3,4,5,6 months later ]
    Depress symptoms scores will be assessed with Beck Depression Inventory

  4. Change of anxiety symptoms [ Time Frame: Baseline, 1 week later, 1,2,3,4,5,6 months later ]
    Anxiety symptoms scores will be assessed with Hamilton Anxiety Scale

  5. Change of impulsive behaviors [ Time Frame: Baseline, 1 week later, 1,2,3,4,5,6 months later ]
    Impulsive behaviors scores will be assessed with Barratt impulsiveness scale

  6. Change of sleep [ Time Frame: Baseline, 1 week later, 1,2,3,4,5,6 months later ]
    Sleep scores will be assessed with Pittsburgh sleep quality index

  7. Change of functional connectivity between dorsolateral prefrontal cortex and whole brain [ Time Frame: Baseline, 1 week later, 1,3,6 months later ]
    Functional connectivity based on dorsolateral prefrontal cortex will be measured with magnetic resonance imaging based on blood oxygen level dependence

  8. Change of gray matter volume of whole brain [ Time Frame: Baseline, 1 week later, 1,3,6 months later ]
    Gray matter volume will be measured with magnetic resonance imaging (high resolution T1-weighted image)

  9. Change of white matter integrity of whole brain [ Time Frame: Baseline, 1 week later, 1,3,6 months later ]
    Fractional anisotropy, axial diffusivity and radial diffusivity will be measured with magnetic resonance imaging (diffusion tensor imaging)

  10. Change of availability of dopamine 2 receptor of whole brain [ Time Frame: Baseline, 1 month later ]
    Accumulation of 11C-raclopride will be analyzed by time-related Positron emission tomography

  11. Change of metabolism of glucose in the brain [ Time Frame: Baseline, 1 month later ]
    Accumulation of 18F-FDG will be analyzed by time-related Positron emission tomography



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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086459


Contacts
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Contact: Qiang Li, phd 8615991610831 tdqiangqiang@foxmail.com

Locations
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China, Shaanxi
Tangdu Hospital Recruiting
Xi'an, Shaanxi, China, 710038
Contact: Qiang Li, PHD    8615991610831    tdqiangqiang@foxmail.com   
Sponsors and Collaborators
Tang-Du Hospital
Investigators
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Principal Investigator: Longxiao Wei, phd Tang-Du Hospital

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Responsible Party: Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT04086459     History of Changes
Other Study ID Numbers: Addiction-No.1
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tang-Du Hospital:
Repetitive transcranial magnetic stimulation
Functional magnetic resonance imaging
Positron emission tomography
Additional relevant MeSH terms:
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Heroin Dependence
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Heroin
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents