Heroin AddictionNCT04086459
PET/MRI Study on the Neurological Mechanism of rTMS Treatment for Heroin Addiction
A study testing Repetitive transcranial magnetic stimulation in people with Heroin Addiction and Relapse, run by Tang-Du Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Heroin Addiction, Relapse
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PET/MRI Study on the Neurological Mechanism of rTMS Treatment for Heroin Addiction by Stimulating Left Dorsolateral Prefrontal Cortex
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
- Being tested
- Repetitive transcranial magnetic stimulation
- Keywords
- Repetitive transcranial magnetic stimulation, Functional magnetic resonance imaging, Positron emission tomography
- Medical subject headings
- Heroin Dependence, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Active repetitive transcranial magnetic stimulation | Active comparator | Not described Receives: Device: Repetitive transcranial magnetic stimulation |
| Sham repetitive transcranial magnetic stimulation | Sham comparator | Not described Receives: Device: Repetitive transcranial magnetic stimulation |
| No repetitive transcranial magnetic stimulation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of craving
Craving scores will be assessed with visual analogue scale
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Baseline, 1 month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start1 Jun 2019
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heroin AddictionStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Longxiao Wei, phd, Principal investigator, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086459
- Sponsor's protocol ID
- Addiction-No.1
- Status last verified
- Jan 2021
- First submitted
- 2 Sep 2019
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/MRI Study on the Neurological Mechanism of rTMS Treatment for Heroin Addiction by Stimulating Left Dorsolateral Prefrontal Cortex
- ClinicalTrials.gov ID
- NCT04086459
- Acronym / sponsor ID
- Addiction-No.1
- Conditions
- Heroin Addiction, Relapse
- Keywords
- Repetitive transcranial magnetic stimulation, Functional magnetic resonance imaging, Positron emission tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive transcranial magnetic stimulationThose 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) | Device | Active repetitive transcranial magnetic stimulation, Sham repetitive transcranial magnetic stimulation |
Primary outcome
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
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
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
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
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
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
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
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)
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)
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Longxiao Wei, phd principal investigator
Tang-Du Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation in people with Heroin Addiction and Relapse, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of craving (time frame: Baseline, 1 week later, 1,2,3,4,5,6 months later). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.