AddictionNCT01658592
Deep Brain Stimulation of the Nucleus Accumbens and the Ventral Anterior Internal Capsule for Severe Alcohol Addiction
A study testing Deep brain stimulation in people with Addiction, run by Guodong Gao at 1 site in China.
Trial summary
The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the nucleus accumbens (NAc) and the ventral anterior internal capsule (VC) as a novel treatment in severe alcohol addiction. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Addiction
- What is being tested?
- Deep brain stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Mar 2014
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Age > 18 years
- Long lasting alcohol addiction (fulfilled diagnostic-criteria according to DSM-IV,ICD-10)
- At least one detoxication-treatment without a long-term period of abstinence has already taken place
- Long-term inpatient treatment to support abstinence have occurred
- Free patient's decision / Informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance)
- If prior medication, stable dosage of psychopharmacological drugs over the last three months, which shall, after checking be retained during the study
Who cannot join
- Hospitalization for psychotic symptoms
- Clinical relevant psychiatric comorbidity (such as schizophrenic psychoses, bipolar affective diseases, severe personality disorder, and so on. And diagnosed by criteria according to DSM-IV,ICD-10)
- 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
- Verbal IQ < 85 (evaluated with the Wechsler Adult Intelligence Scale- Chinese Revised (WAIS-CR)
Show all 12Show fewer
- Stereotactic respectively neurosurgical intervention in the past
- Other neurological diseases
- Contraindications of a stereotactic operation, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)
- 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
Gao G Dong, Doctor, +86 29-84777435, gguodong@fmmu.edu.cn
Wang X Lian, Doctor, +86 29-84777284, tdwxlian@126.com
About this study
Official title: Deep Brain Stimulation of the Nucleus Accumbens and the Ventral Anterior Internal Capsule as a Novel Treatment in Severe Alcohol Addiction
The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the nucleus accumbens (NAc) and the ventral anterior internal capsule (VC) as a novel treatment in severe alcohol addiction. The included patients have been treated so far with drugs that inhibits alcohol, or psychological behavior training.
Our hypothesis is that bilateral NAc-VC DBS will significantly reduce the craving for alcohol and thus enable the patients to decrease their alcohol intake substantially.
Read the detailed description
The nucleus accumbens (NAc) is considered associating with addiction. The ventral anterior internal capsule(VC) is proved a effective target to obsessive compulsive disorder(OCD). Like other addiction behaviors most alcohol addicts contain obsessive compulsive symptom. We explored an operation method, that is, in the Leksell stereotactic positioning system take VC as the point of entry, take NAc as the point of target, then make sure that the distance between entry and target points are included in the four contacts of electrode of DBS. When stimulator is ON the investigators can adjust parameters so that the coverage of electrode contains both Vc and NAc. The investigators suppose that bilateral NAc-VC DBS will significantly reduce the craving for alcohol and thus enable the patients to decrease their alcohol intake substantially.
- Conditions
- Addiction
- Being tested
- Deep brain stimulation, Placebo
- Keywords
- Alcohol Addiction;, Deep Brain Stimulation;, Nucleus Accumbens;, Ventral Anterior Internal capsule;
- Medical subject headings
- Behavior, Addictive, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationOther
Stimulator setting is ON
PlaceboOther
Stimulator setting is OFF
| Study group | Role | What they receive |
|---|---|---|
| NAC-VC Deep Brain Stimulation | Experimental | The contractors located in NAc and VC are ON at the same time Receives: Other: Deep brain stimulation; Other: Placebo |
| Placebo A | Sham comparator | Stimulator setting is OFF Receives: Other: Deep brain stimulation; Other: Placebo |
| Placebo B | Experimental | The contractor located in NAc is on Receives: Other: Deep brain stimulation; Other: Placebo |
| Placebo C | Experimental | The contactor located in VC is on Receives: Other: Deep brain stimulation; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Alcohol
Reduction of the dosage of alcohol(all kinds of liquor were converted into pure alcohol) comparing baseline and the particular ward rounds during and at the end of the crossover-design.
Measured: 7 months
Secondary outcomes (1)
Craving
10-point visual analog scale (VAS) of craving
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictionStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guodong Gao
- Sponsor type
- University, hospital or other
- Collaborators
- Tang-Du Hospital
- Responsible party
- Sponsor-investigator, Guodong Gao, Tang-Du Hospital
- Investigators
- Gao G Dong, Doctor, Principal investigator, Department of neurosurgery, Tangdu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658592
- Sponsor's protocol ID
- NAc-VC DBS for alcohol addict
- Status last verified
- Aug 2012
- First submitted
- 26 Jul 2012
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation of the Nucleus Accumbens and the Ventral Anterior Internal Capsule as a Novel Treatment in Severe Alcohol Addiction
- ClinicalTrials.gov ID
- NCT01658592
- Acronym / sponsor ID
- NAc-VC DBS for alcohol addict
- Conditions
- Addiction
- Keywords
- Alcohol Addiction;, Deep Brain Stimulation;, Nucleus Accumbens;, Ventral Anterior Internal capsule;
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guodong GaoUniversity, hospital or other
- Collaborators
- Tang-Du Hospital
- Study start
- Jul 2012
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 7 Aug 2012 (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.
The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the nucleus accumbens (NAc) and the ventral anterior internal capsule (VC) as a novel treatment in severe alcohol addiction. The included patients have been treated so far with drugs that inhibits alcohol, or psychological behavior training.
Our hypothesis is that bilateral NAc-VC DBS will significantly reduce the craving for alcohol and thus enable the patients to decrease their alcohol intake substantially.
Detailed description
The nucleus accumbens (NAc) is considered associating with addiction. The ventral anterior internal capsule(VC) is proved a effective target to obsessive compulsive disorder(OCD). Like other addiction behaviors most alcohol addicts contain obsessive compulsive symptom. We explored an operation method, that is, in the Leksell stereotactic positioning system take VC as the point of entry, take NAc as the point of target, then make sure that the distance between entry and target points are included in the four contacts of electrode of DBS. When stimulator is ON the investigators can adjust parameters so that the coverage of electrode contains both Vc and NAc. The investigators suppose that bilateral NAc-VC DBS will significantly reduce the craving for alcohol and thus enable the patients to decrease their alcohol intake substantially.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NAC-VC Deep Brain Stimulation | Experimental | Other: Deep brain stimulation, Other: PlaceboThe contractors located in NAc and VC are ON at the same time |
| Placebo A | Sham comparator | Other: Deep brain stimulation, Other: PlaceboStimulator setting is OFF |
| Placebo B | Experimental | Other: Deep brain stimulation, Other: PlaceboThe contractor located in NAc is on |
| Placebo C | Experimental | Other: Deep brain stimulation, Other: PlaceboThe contactor located in VC is on |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age > 18 years
- Long lasting alcohol addiction (fulfilled diagnostic-criteria according to DSM-IV,ICD-10)
- At least one detoxication-treatment without a long-term period of abstinence has already taken place
- Long-term inpatient treatment to support abstinence have occurred
- Free patient's decision / Informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance)
Key exclusion criteria (12 listed)
- Hospitalization for psychotic symptoms
- Clinical relevant psychiatric comorbidity (such as schizophrenic psychoses, bipolar affective diseases, severe personality disorder, and so on. And diagnosed by criteria according to DSM-IV,ICD-10)
- 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
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 stimulationStimulator setting is ON | Other | NAC-VC Deep Brain Stimulation, Placebo A, Placebo B, Placebo C |
| PlaceboStimulator setting is OFF | Other | NAC-VC Deep Brain Stimulation, Placebo A, Placebo B, Placebo C |
Primary outcome
Reduction of Alcohol
Time frame: 7 months
Reduction of the dosage of alcohol(all kinds of liquor were converted into pure alcohol) comparing baseline and the particular ward rounds during and at the end of the crossover-design.
1 secondary outcome
Craving
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
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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.
Gao G Dong, Doctor 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 in people with Addiction, run by Guodong Gao 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 12 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 7 Aug 2012. 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?
Contact Gao G Dong, Doctor (+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?
Reduction of Alcohol (time frame: 7 months). 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 7 Aug 2012.