Deep Brain Stimulation of Nucleus Accumbens to Prevent Opiate Relapse
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|ClinicalTrials.gov Identifier: NCT01274988|
Recruitment Status : Unknown
Verified April 2014 by Guodong Gao, Tang-Du Hospital.
Recruitment status was: Recruiting
First Posted : January 12, 2011
Last Update Posted : April 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Addiction||Procedure: Deep brain stimulation Other: methadone maintenance treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Deep Brain Stimulation of Nucleus Accumbens as a New Treatment to Prevent Relapse for Opiate Addicts|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||December 2015|
Experimental: Deep Brain Stimulation
Continuous deep brain stimulation of bilateral nucleus accumbens
Procedure: Deep brain stimulation
Deep brain stimulation of bilateral nucleus accumbens
Active Comparator: Standard Control
methadone maintenance treatment
Other: methadone maintenance treatment
methadone maintenance treatment
- Treatment retention [ Time Frame: 12 months ]Opiate abstinent time by self-reports and monthly urinalysis for the patients undergo the deep brain stimulation of nucleus accumbens,treatment retention time for the methadone maintenance treatment patients
- Change of participants' craving for opioid drugs [ Time Frame: Baseline, 3 month, 6 month and 12month follow-up assessments ]The 10-point visual analog scale (VAS),will be utilized at each time point. A participants' diary will be utilized at each time point.
- Change in Addiction Severity Index (ASI lite) composite scores [ Time Frame: Baseline, 3 month, 6 month and 12month follow-up assessments ]
- Psychological evaluation [ Time Frame: Baseline, 3 month, 6 month and 12month follow-up assessments ]The Symptom Checklist - 90 (SCL-90) for evaluating general status, Self-Rating Depression Scale (SDS)for evaluating depression symptom,and Yale-Brown Obsessive Compulsive Scale (Y-BOCS) for evaluating obsessive compulsive symptom, will be utilized at each time point.
- Personality evaluation [ Time Frame: Baseline, 3 month, 6 month and 12month follow-up assessments ]The Eysenck Personality Questionnaire (EPQ)will be utilized at each time point.
- Cognitive evaluation [ Time Frame: Baseline, 3 month, 6 month and 12month follow-up assessments ]The Wechsler Memory Scale(WMS) for evaluating the memory will be utilized at each time point.
- Evaluation of quality of life [ Time Frame: Baseline, 3 month, 6 month and 12 month follow-up assessments ]The MOS item short from health survey(SF-36) be utilized at each time point.
- Change in two static positron emission tomography(PET) images study [ Time Frame: Baseline and 6month follow-up ][18F]fluoro-D-glucose (FDG) for evaluating cerebral metabolism will be utilized at each time point.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274988
|Contact: Guo-dong Gao, M.D.||+86 29 email@example.com|
|Contact: Xue-lian Wang, M.D.||+86 29 firstname.lastname@example.org|
|Department of neurosurgery, Tangdu Hospital||Recruiting|
|Xi'an, Shaanxi, China, 710038|
|Contact: Guo-dong Gao, M.D. +86 29 84777435 email@example.com|
|Sub-Investigator: Xue-lian Wang, M.D.|
|Principal Investigator:||Guo-dong Gao, M.D.||Department of neurosurgery, Tangdu Hospital|