Substance-Related DisordersNCT02594306
Brain Electrophysiological Study(EEG/ERP) on Opiate Addicts Treating by Bilateral NAc/ALIC Deep Brain Stimulation
A study testing Emotional pictures stimulation system, Deep brain stimulation and adjacent contact stimulation in people with Substance-Related Disorders, run by Tang-Du Hospital at 1 site in China.
Trial summary
Drug addiction is compulsive and spontaneous drug-taking behavior which is characterized by non-medical usage, long and repeated exposure to addictive drugs and gradually increasing drug-taking dosage and frequency,and become a main threat against human being's public health, economic development and social safety. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Emotional pictures stimulation system, Deep brain stimulation and adjacent contact stimulation
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Nov 2016
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 65 years of age, male or female；
- Opiate addictive over 3 years；
- Physical detoxification completed（keep abstinent for at least 7 days，acute abstinent syndrome disappeared，morphine urinalysis and naloxone test showed negative)；
- No obvious neuropsychiatry and personality disorders；
- No severe infectious disease；
- Good compliance and be able to complete follow up；
- General health is good，no severe liver、kidney、heart and lung disease；
- Informed consent issued
Who cannot join
- Severe cognitive disorders（MMSE scale: illiteracy≤17，primary school≤20，secondary school or above≤24）,bad compliance because of dementia,unable to issue the informed content；
- History of severe neuropsychiatric disease；
- Epilepsy；
- severe liver、kidney、heart and lung disease, severe hypertension and severe orthostatic hypotension；
- Malignant tumor；History of brain trauma；Pregnant female；
- Patients are taking part in other clinical trials in recent 3 months；
- Being deem as unfit for the trials by researcher.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of neurosurgery, Tangdu Hospital
Xi'an, Shaanxi, 710038
Guo-dong Gao, M.D., +86 29 84777435, gguodong@fmmu.edu.cn
Xue-lian Wang, M.D.
About this study
Drug addiction is compulsive and spontaneous drug-taking behavior which is characterized by non-medical usage, long and repeated exposure to addictive drugs and gradually increasing drug-taking dosage and frequency,and become a main threat against human being's public health, economic development and social safety.
Read the detailed description
Effective treatments for severe drug addiction are limited. China centers employing compulsory detoxification, reported a 3 year abstinence rate of only 15%. For the methadone maintenance therapy, relapse often occurs promptly after cessation of methadone. A Malaysian reports about taking naltrexone or buprenorphine treating,showed average relapsed time of 2 or 3 months,respectively.
Assessment for psychological craving degree of addiction patients is also a difficult thing.
- Conditions
- Substance-Related Disorders
- Being tested
- Emotional pictures stimulation system, Deep brain stimulation, adjacent contact stimulation, microelectrode
- Keywords
- drug addiction, Heroin, craving, event related potential, crystal methamphetamine
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional pictures stimulation systemDevice
Emotional pictures stimulation system is component of neutral and drug-related images.
Deep brain stimulationProcedure or surgery
Deep brain stimulation of bilateral NAc/ALIC
adjacent contact stimulationProcedure or surgery
The electrode of deep brain stimulation has four contacts.We stimulate one contact,and record the local field potential of other contacts.
microelectrodeProcedure or surgery
We put the microelectrodes into bilateral nucleus accumbens and anterior limb of the internal capsule,to record the waveform of bilateral NAc/ALIC.
| Study group | Role | What they receive |
|---|---|---|
| Non operation | Experimental | Recording the event related potential of drug addicts when they receive the stimulus of Emotional pictures stimulation system. Receives: Device: Emotional pictures stimulation system |
| Deep brain stimulation | Experimental | Recording the event related potential after the deep brain stimulation operation.Recording the local field potential of drug addiction people when we conduct a test of adjacent contact stimulation in the deep brain stimulation operation. Recording the waveform of bilateral NAc/ALIC after puting the microelectrodes into bilateral nucleus accumbens and anterior limb of the internal capsule Receives: Device: Emotional pictures stimulation system; Procedure: Deep brain stimulation; Procedure: adjacent contact stimulation; Procedure: microelectrode |
| Standard Control | Active comparator | Recording the event related potential of normal people when they receive the stimulus of emotional pictures stimulation system. Receives: Device: Emotional pictures stimulation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event related potentials(ERPs)
Event related potentials include late positive potential（LPP),P300,mismatch negativity(MMN) and N400.Recording the event related potential when people receive the stimulus of emotional pictures stimulation system.
Measured: Day 3
Secondary outcomes (9)
local field potential(LFP)
Recording the LFP of DBS group without any stimulation and stimulate one contact in surgery and 3 days after surgery.
Measured: in surgery,3 days after surgery
the 13-item obsessive compulsive drug use scale(OCDUS)
Measured: day 3
Opiate Addiction Severity Inventory(OASI)
Measured: day 3
participants' craving for opioid drugs (VAS)
The 10-point visual analog scale(VAS)will be utilized at day 3.
Measured: day 3
The Symptom Checklist-90(SCL-90)
The Symptom Checklist-90(SCL-90) is used to evaluate general status.
Measured: day 3
Self-Rating Depression Scale(SDS)
Self-Rating Depression Scale(SDS) is used to evaluate depression symptom.
Measured: day 3
Yale-Brown Obsessive Compulsive Scale(Y-BOCS)
Yale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom.
Measured: day 3
The Eysenck Personality Questionnaire(EPQ)
Measured: day 3
The Wechsler Memory Scale(WMS)
Measured: day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guodong Gao, Tang-Du Hospital
- Investigators
- Guo-dong Gao, M.D., Study chair, Department of neurosurgery, Tangdu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594306
- Sponsor's protocol ID
- EEG/ERP and drug addiction
- Status last verified
- Feb 2016
- First submitted
- 14 Oct 2015
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Electrophysiological Study(EEG/ERP) on Opiate Addicts Treating by Bilateral NAc/ALIC Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT02594306
- Acronym / sponsor ID
- EEG/ERP and drug addiction
- Conditions
- Substance-Related Disorders
- Keywords
- drug addiction, Heroin, craving, event related potential, crystal methamphetamine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 3 Nov 2015 (estimated)
- 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.
Drug addiction is compulsive and spontaneous drug-taking behavior which is characterized by non-medical usage, long and repeated exposure to addictive drugs and gradually increasing drug-taking dosage and frequency,and become a main threat against human being's public health, economic development and social safety.
Detailed description
Effective treatments for severe drug addiction are limited. China centers employing compulsory detoxification, reported a 3 year abstinence rate of only 15%. For the methadone maintenance therapy, relapse often occurs promptly after cessation of methadone. A Malaysian reports about taking naltrexone or buprenorphine treating,showed average relapsed time of 2 or 3 months,respectively.
Assessment for psychological craving degree of addiction patients is also a difficult thing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non operation | Experimental | Device: Emotional pictures stimulation systemRecording the event related potential of drug addicts when they receive the stimulus of Emotional pictures stimulation system. |
| Deep brain stimulation | Experimental | Device: Emotional pictures stimulation system, Procedure: Deep brain stimulation, Procedure: adjacent contact stimulation, Procedure: microelectrodeRecording the event related potential after the deep brain stimulation operation.Recording the local field potential of drug addiction people when we conduct a test of adjacent contact stimulation in the deep brain stimulation operation. Recording the waveform of bilateral NAc/ALIC after puting the microelectrodes into bilateral nucleus accumbens and anterior limb of the internal capsule |
| Standard Control | Active comparator | Device: Emotional pictures stimulation systemRecording the event related potential of normal people when they receive the stimulus of emotional pictures stimulation system. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age between 18 and 65 years of age, male or female；
- Opiate addictive over 3 years；
- Physical detoxification completed（keep abstinent for at least 7 days，acute abstinent syndrome disappeared，morphine urinalysis and naloxone test showed negative)；
- No obvious neuropsychiatry and personality disorders；
- No severe infectious disease；
Key exclusion criteria (7 listed)
- Severe cognitive disorders（MMSE scale: illiteracy≤17，primary school≤20，secondary school or above≤24）,bad compliance because of dementia,unable to issue the informed content；
- History of severe neuropsychiatric disease；
- Epilepsy；
- severe liver、kidney、heart and lung disease, severe hypertension and severe orthostatic hypotension；
- Malignant tumor；History of brain trauma；Pregnant female；
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 |
|---|---|---|
| Emotional pictures stimulation systemEmotional pictures stimulation system is component of neutral and drug-related images. | Device | Deep brain stimulation, Non operation, Standard Control |
| Deep brain stimulationDeep brain stimulation of bilateral NAc/ALIC | Procedure or surgery | Deep brain stimulation |
| adjacent contact stimulationThe electrode of deep brain stimulation has four contacts.We stimulate one contact,and record the local field potential of other contacts. | Procedure or surgery | Deep brain stimulation |
| microelectrodeWe put the microelectrodes into bilateral nucleus accumbens and anterior limb of the internal capsule,to record the waveform of bilateral NAc/ALIC. | Procedure or surgery | Deep brain stimulation |
Primary outcome
Event related potentials(ERPs)
Time frame: Day 3
Event related potentials include late positive potential（LPP),P300,mismatch negativity(MMN) and N400.Recording the event related potential when people receive the stimulus of emotional pictures stimulation system.
9 secondary outcomes
local field potential(LFP)
Time frame: in surgery,3 days after surgery
the 13-item obsessive compulsive drug use scale(OCDUS)
Time frame: day 3
Opiate Addiction Severity Inventory(OASI)
Time frame: day 3
participants' craving for opioid drugs (VAS)
Time frame: day 3
The Symptom Checklist-90(SCL-90)
Time frame: day 3
Self-Rating Depression Scale(SDS)
Time frame: day 3
Yale-Brown Obsessive Compulsive Scale(Y-BOCS)
Time frame: day 3
The Eysenck Personality Questionnaire(EPQ)
Time frame: day 3
The Wechsler Memory Scale(WMS)
Time frame: day 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
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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.
Guo-dong Gao, M.D. study chair
Department of neurosurgery, Tangdu 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 Emotional pictures stimulation system, Deep brain stimulation and adjacent contact stimulation in people with Substance-Related Disorders, 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 8 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 19 Feb 2016. 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. 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?
Contact Guo-dong Gao, M.D. (+86 29 84777435, gguodong@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event related potentials(ERPs) (time frame: Day 3). 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 19 Feb 2016.