Deep Brain Stimulation of the Nucleus Accumbens as a Novel Treatment in Severe Opioid Addiction (NASA)
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|ClinicalTrials.gov Identifier: NCT01245075|
Recruitment Status : Unknown
Verified December 2016 by Jens Kuhn, University of Cologne.
Recruitment status was: Recruiting
First Posted : November 22, 2010
Last Update Posted : December 7, 2016
The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the Nucleus accumbens (NAc) as a novel treatment in severe opioid addiction. The included patients have been treated so far with a substitute in form of methadone.
Our hypothesis is that bilateral DBS of the NAc will significantly reduce the craving for heroin and thus enable the patients to decrease their Levomethadone-dosage substantially.
|Condition or disease||Intervention/treatment||Phase|
|Addiction||Other: Deep brain stimulation Other: Placebo||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Deep Brain Stimulation of the Nucleus Accumbens as a Novel Treatment in Severe Opioid Addiction|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2017|
Active Comparator: Deep Brain Stimulation
Stimulator setting is ON
Other: Deep brain stimulation
Deep brain stimulation on
Sham Comparator: Placebo
Stimulator setting is OFF
deep brain stimulation off
- Reduction of Levomethadone [ Time Frame: seven month ]Reduction of the dosage of the substitute (in detail Levomethadone) comparing baseline and the particular ward rounds during and at the end of the crossover-design.
- Drug seeking, goal directed behavior, Craving, Psychological components Laboratory parameters in the urine (parallel consumption of other drugs) [ Time Frame: seven month ]Drug seeking and goal directed behavior (accessed with EEG) Craving (10-point visual analog scale (VAS)) Psychological components (Anxiety (HAMA); Depression (BDI-II); Quality of life (MSLQ) . Laboratory parameters in the urine (parallel consumption of other drugs)
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): NCT01245075
|Contact: Jens Kuhn, MDfirstname.lastname@example.org|
|Contact: Veerle Visser-Vandewalle, MDemail@example.com|
|University of Cologne||Recruiting|
|Cologne, Germany, 50924|
|Principal Investigator:||Veerle Visser-Vandewalle, MD||University of Cologne|
|Principal Investigator:||Jens Kuhn, MD||University of Cologne|