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

Primary Purpose

Heroin Addiction, Relapse

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation
Sponsored by
Tang-Du Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heroin Addiction focused on measuring Repetitive transcranial magnetic stimulation, Functional magnetic resonance imaging, Positron emission tomography

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Tangdu Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

No Intervention

Arm Label

Active repetitive transcranial magnetic stimulation

Sham repetitive transcranial magnetic stimulation

No repetitive transcranial magnetic stimulation

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 2, 2019
Last Updated
January 20, 2021
Sponsor
Tang-Du Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04086459
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tang-Du Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Addiction, Relapse
Keywords
Repetitive transcranial magnetic stimulation, Functional magnetic resonance imaging, Positron emission tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Masking Description
Either the participants, care providers, or outcomes assessors did not know which repetitive transcranial magnetic stimulation is active or sham.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active repetitive transcranial magnetic stimulation
Arm Type
Active Comparator
Arm Title
Sham repetitive transcranial magnetic stimulation
Arm Type
Sham Comparator
Arm Title
No repetitive transcranial magnetic stimulation
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change of craving
Description
Craving scores will be assessed with visual analogue scale
Time Frame
Baseline, 1 week later, 1,2,3,4,5,6 months later
Title
Change of protracted-abstinence symptoms
Description
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
Title
Change of depress symptoms
Description
Depress symptoms scores will be assessed with Beck Depression Inventory
Time Frame
Baseline, 1 week later, 1,2,3,4,5,6 months later
Title
Change of anxiety symptoms
Description
Anxiety symptoms scores will be assessed with Hamilton Anxiety Scale
Time Frame
Baseline, 1 week later, 1,2,3,4,5,6 months later
Title
Change of impulsive behaviors
Description
Impulsive behaviors scores will be assessed with Barratt impulsiveness scale
Time Frame
Baseline, 1 week later, 1,2,3,4,5,6 months later
Title
Change of sleep
Description
Sleep scores will be assessed with Pittsburgh sleep quality index
Time Frame
Baseline, 1 week later, 1,2,3,4,5,6 months later
Title
Change of functional connectivity between dorsolateral prefrontal cortex and whole brain
Description
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
Title
Change of gray matter volume of whole brain
Description
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
Title
Change of white matter integrity of whole brain
Description
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
Title
Change of availability of dopamine 2 receptor of whole brain
Description
Accumulation of 11C-raclopride will be analyzed by time-related Positron emission tomography
Time Frame
Baseline, 1 month later
Title
Change of metabolism of glucose in the brain
Description
Accumulation of 18F-FDG will be analyzed by time-related Positron emission tomography
Time Frame
Baseline, 1 month later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Longxiao Wei, phd
Organizational Affiliation
Tang-Du Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tangdu Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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