AddictionNCT01274988
Deep Brain Stimulation of Nucleus Accumbens to Prevent Opiate Relapse
A study testing Deep brain stimulation and methadone maintenance treatment in people with Addiction, run by Tang-Du Hospital at 1 site in China.
Trial summary
Nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification, deep brain stimulation of nucleus accumbens will inhibit its activity and thus to effectively prevent the relapse of the opiate dependence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Addiction
- What is being tested?
- Deep brain stimulation and methadone maintenance treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Feb 2011to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Long lasting heroin addiction (fulfilled diagnostic-criteria according to ICD-10)
- At least three detoxication-treatments without a long-term period of abstinence has already taken place
- Long-term inpatient treatment to support abstinence have occurred
- completion of detoxification treatment preoperatively with no somatic symptoms of withdrawal
- negative morphine urinalysis and naloxone tests
- Free patient's decision/informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance)
Who cannot join
- Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases, severe personality disorder)
- Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/heart defibrillator
- Current and in the last six months existent paranoid-hallucinated symptomatology
- Foreign aggressiveness in the last six months
- Stereotactic respectively neurosurgical intervention in the past
- Contraindications of a stereotactic operation, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)
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- Serious and instable organic diseases (e.g. instable coronal heart disease)
- tested positively for HIV
- pregnancy and/or lactation
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
Official title: Deep Brain Stimulation of Nucleus Accumbens as a New Treatment to Prevent Relapse for Opiate Addicts
Nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification, deep brain stimulation of nucleus accumbens will inhibit its activity and thus to effectively prevent the relapse of the opiate dependence.
- Conditions
- Addiction
- Being tested
- Deep brain stimulation, methadone maintenance treatment
- Keywords
- Opiate dependence, Deep brain stimulation, Nucleus accumbens
- Medical subject headings
- Behavior, Addictive, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationProcedure or surgery
Deep brain stimulation of bilateral nucleus accumbens
methadone maintenance treatmentOther
methadone maintenance treatment
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation | Experimental | Continuous deep brain stimulation of bilateral nucleus accumbens Receives: Procedure: Deep brain stimulation |
| Standard Control | Active comparator | methadone maintenance treatment Receives: Other: methadone maintenance treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment retention
Opiate abstinent time by self-reports and monthly urinalysis for the patients undergo the deep brain stimulation of nucleus accumbens,treatment retention time for the methadone maintenance treatment patients
Measured: 12 months
Secondary outcomes (7)
Change of participants' craving for opioid drugs
The 10-point visual analog scale (VAS),will be utilized at each time point. A participants' diary will be utilized at each time point.
Measured: Baseline, 3 month, 6 month and 12month follow-up assessments
Change in Addiction Severity Index (ASI lite) composite scores
Measured: Baseline, 3 month, 6 month and 12month follow-up assessments
Psychological evaluation
The Symptom Checklist - 90 (SCL-90) for evaluating general status, Self-Rating Depression Scale (SDS)for evaluating depression symptom,and Yale-Brown Obsessive Compulsive Scale (Y-BOCS) for evaluating obsessive compulsive symptom, will be utilized at each time point.
Measured: Baseline, 3 month, 6 month and 12month follow-up assessments
Personality evaluation
The Eysenck Personality Questionnaire (EPQ)will be utilized at each time point.
Measured: Baseline, 3 month, 6 month and 12month follow-up assessments
Cognitive evaluation
The Wechsler Memory Scale(WMS) for evaluating the memory will be utilized at each time point.
Measured: Baseline, 3 month, 6 month and 12month follow-up assessments
Evaluation of quality of life
The MOS item short from health survey(SF-36) be utilized at each time point.
Measured: Baseline, 3 month, 6 month and 12 month follow-up assessments
Change in two static positron emission tomography(PET) images study
[18F]fluoro-D-glucose (FDG) for evaluating cerebral metabolism will be utilized at each time point.
Measured: Baseline and 6month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 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., Principal investigator, Department of neurosurgery, Tangdu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274988
- Sponsor's protocol ID
- NACDBS
- Status last verified
- Apr 2014
- First submitted
- 11 Jan 2011
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen L, Li N, Ge S, Lozano AM, Lee DJ, Yang C, Li L, Bai Q, Lu H, Wang J, Wang X, Li J, Jing J, Su M, Wei L, Wang X, Gao G. Long-term results after deep brain stimulation of nucleus accumbens and the anterior limb of the internal capsule for preventing heroin relapse: An open-label pilot study. Brain Stimul. 2019 Jan-Feb;12(1):175-183. doi: 10.1016/j.brs.2018.09.006. Epub 2018 Sep 14.
PubMed 30245163
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation of Nucleus Accumbens as a New Treatment to Prevent Relapse for Opiate Addicts
- ClinicalTrials.gov ID
- NCT01274988
- Acronym / sponsor ID
- NACDBS
- Conditions
- Addiction
- Keywords
- Opiate dependence, Deep brain stimulation, Nucleus accumbens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 Jan 2011 (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.
Nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification, deep brain stimulation of nucleus accumbens will inhibit its activity and thus to effectively prevent the relapse of the opiate dependence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation | Experimental | Procedure: Deep brain stimulationContinuous deep brain stimulation of bilateral nucleus accumbens |
| Standard Control | Active comparator | Other: methadone maintenance treatmentmethadone maintenance treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years old
- Long lasting heroin addiction (fulfilled diagnostic-criteria according to ICD-10)
- At least three detoxication-treatments without a long-term period of abstinence has already taken place
- Long-term inpatient treatment to support abstinence have occurred
- completion of detoxification treatment preoperatively with no somatic symptoms of withdrawal
Key exclusion criteria (9 listed)
- Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases, severe personality disorder)
- Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/heart defibrillator
- Current and in the last six months existent paranoid-hallucinated symptomatology
- Foreign aggressiveness in the last six months
- Stereotactic respectively neurosurgical intervention in the past
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 |
|---|---|---|
| Deep brain stimulationDeep brain stimulation of bilateral nucleus accumbens | Procedure or surgery | Deep Brain Stimulation |
| methadone maintenance treatmentmethadone maintenance treatment | Other | Standard Control |
Primary outcome
Treatment retention
Time frame: 12 months
Opiate abstinent time by self-reports and monthly urinalysis for the patients undergo the deep brain stimulation of nucleus accumbens,treatment retention time for the methadone maintenance treatment patients
7 secondary outcomes
Change of participants' craving for opioid drugs
Time frame: Baseline, 3 month, 6 month and 12month follow-up assessments
Change in Addiction Severity Index (ASI lite) composite scores
Time frame: Baseline, 3 month, 6 month and 12month follow-up assessments
Psychological evaluation
Time frame: Baseline, 3 month, 6 month and 12month follow-up assessments
Personality evaluation
Time frame: Baseline, 3 month, 6 month and 12month follow-up assessments
Cognitive evaluation
Time frame: Baseline, 3 month, 6 month and 12month follow-up assessments
Evaluation of quality of life
Time frame: Baseline, 3 month, 6 month and 12 month follow-up assessments
Change in two static positron emission tomography(PET) images study
Time frame: Baseline and 6month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
- Derived from this study: PubMed 30245163Chen L, Li N, Ge S, Lozano AM, Lee DJ, Yang C, Li L, Bai Q, Lu H, Wang J, Wang X, Li J, Jing J, Su M, Wei L, Wang X, Gao G. Long-term results after deep brain stimulation of nucleus accumbens and the anterior limb of the internal capsule for preventing heroin relapse: An open-label pilot study. Brain Stimul. 2019 Jan-Feb;12(1):175-183. doi: 10.1016/j.brs.2018.09.006. Epub 2018 Sep 14.
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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. principal investigator
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 Deep brain stimulation and methadone maintenance treatment in people with Addiction, 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 7 inclusion and 9 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 16 Apr 2014. 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?
Treatment retention (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01274988, which also lists 1 linked publication.
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 16 Apr 2014.