Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2007BAI0703
Study information
Scientific title
A randomised blinded trial of nucleus accumbens ablation to treat opiate dependence in humans: location correlates with outcome
Acronym
Study hypothesis
Surgical interventions within the nucleus accumbens are reported to have variable rates of efficacy and complications for a range of neuropsychiatric illnesses. We hypothesize that slight variations in lesion location may have an important influence on clinical outcome. To investigate the optimal lesion site, we established a prospective randomised double-blinded trial to analyze opiate abstinence and complication rate in different radiofrequency ablation lesion locations within the nucleus accumbens (NAc).
Ethics approval
Ethics Committee of Fourth Military Medical University approved on the 15th October 2003.
Study design
Randomised single centre prospective double-blinded interventional clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Functional neurosurgery for drug addiction
Intervention
1. Radiofrequency ablation of the NAc
2. Different lesioning location and volumn within NAc in four groups
3. Abstinence from opioid use and adverse events related to operation
4. Neuropsychiatric functional changes, measured by formal neuropsychiatric instruments
Follow up length: 4 years
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Abstinence from opioid use, measured by morphine urinalysis and naloxone testing in the fourth post-operative year
Secondary outcome measures
1. Complications in stereoctactic surgery (e.g fever, nausea/emesis, seizure, infection, intracranial haemorrhages)
2. Possible neuropsychiatric change related to NAc ablation: memory, motivation, emotion, olfactory sensation
After operation, the secondary outcomes were measured at six month intervals and extended for four years.
Overall trial start date
01/01/2004
Overall trial end date
30/11/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Heroin abuse using 0.3 - 1.0 g daily for at least 3 years by intravenous injection with or without concomitant nasal inhalation
2. Failure of multiple other treatment modalities
3. Ages between 18 and 50 years, either sex
4. Completion of detoxification treatment preoperatively with no somatic symptoms of withdrawal and negative morphine urinalysis and naloxone tests
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Inability to give informed consent
2. Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) virus carrier
3. Developmental delay, cognitive impairment, personality disorders and neuropsychiatric diseases other than addiction
Recruitment start date
01/01/2004
Recruitment end date
30/11/2004
Locations
Countries of recruitment
China
Trial participating centre
1# Xinsi Road, Baqiao District.
Xi'an
710038
China
Sponsor information
Organisation
Ministry of Science and Technology (China)
Sponsor details
15B Fuxin Road
Beijing
100862
China
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ministry of Science and Technology (China) (ref: 2007BAI0703)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list