Condition category
Surgery
Date applied
19/01/2011
Date assigned
17/02/2011
Last edited
17/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Guodong Gao

ORCID ID

Contact details

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

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 measures

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

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

http://www.most.gov.cn/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes