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

NCT04086459 | Unknown

• 1 other identifier: Addiction-No.1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Heroin Addiction; Relapse

Keywords

Repetitive transcranial magnetic stimulation; Functional magnetic resonance imaging; Positron emission tomography

Outcome Measures

Primary Outcomes (11)

• Change of craving

  Craving scores will be assessed with visual analogue scale

  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

  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

  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

  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

  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

  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

  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)

  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)

  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

  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

  Baseline, 1 month later

Study Arms (3)

Active repetitive transcranial magnetic stimulation

ACTIVE COMPARATOR

Device: Repetitive transcranial magnetic stimulation

Sham repetitive transcranial magnetic stimulation

SHAM COMPARATOR

Device: Repetitive transcranial magnetic stimulation

No repetitive transcranial magnetic stimulation

NO INTERVENTION

Interventions

Repetitive transcranial magnetic stimulation DEVICE

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)

Active repetitive transcranial magnetic stimulation; Sham repetitive transcranial magnetic stimulation

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Clinical diagnosis of Healthy Control
• Right-handed

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

Location

MeSH Terms

Conditions

Heroin Dependence; Recurrence

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Longxiao Wei, phd

  Tang-Du Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Either the participants, care providers, or outcomes assessors did not know which repetitive transcranial magnetic stimulation is active or sham.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 11, 2019
• Study Start: June 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2022
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)