The relations between location and outcome in stereotactic neurosurgery for drug abuse
| ISRCTN | ISRCTN33954423 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33954423 |
| Protocol serial number | 2007BAI0703 |
| Sponsor | Ministry of Science and Technology (China) |
| Funder | Ministry of Science and Technology (China) (ref: 2007BAI0703) |
- Submission date
- 19/01/2011
- Registration date
- 17/02/2011
- Last edited
- 17/02/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Guodong Gao
Scientific
Scientific
1# Xinsi Road, Baqiao District.
Xi'an
710038
China
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised single centre prospective double-blinded interventional clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised blinded trial of nucleus accumbens ablation to treat opiate dependence in humans: location correlates with outcome |
| Study objectives | 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(s) | Ethics Committee of Fourth Military Medical University approved on the 15th October 2003. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Abstinence from opioid use, measured by morphine urinalysis and naloxone testing in the fourth post-operative year |
| Key secondary outcome measure(s) |
1. Complications in stereoctactic surgery (e.g fever, nausea/emesis, seizure, infection, intracranial haemorrhages) |
| Completion date | 30/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 30/11/2004 |
Locations
Countries of recruitment
- China
Study participating centre
1# Xinsi Road, Baqiao District.
Xi'an
710038
China
710038
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
