The relations between location and outcome in stereotactic neurosurgery for drug abuse

ISRCTN	ISRCTN33954423
DOI	https://doi.org/10.1186/ISRCTN33954423
Secondary identifying numbers	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

1# Xinsi Road, Baqiao District.
Xi'an
710038
China

Study information

Study design	Randomised single centre prospective double-blinded interventional clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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 study start date	01/01/2004
Completion date	30/11/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

Sponsor information

Ministry of Science and Technology (China)
Government

15B Fuxin Road
Beijing
100862
China

Website	http://www.most.gov.cn/
"ROR"	https://ror.org/027s68j25

Funders

Funder type

Government

Ministry of Science and Technology (China) (ref: 2007BAI0703)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan