Clinical Trial: Deep Brain Stimulation of the Nucleus Accumbens as a Novel Treatment in Severe Opioid Addiction

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Deep Brain Stimulation of the Nucleus Accumbens as a Novel Treatment in Severe Opioid Addiction

Brief Summary:

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.


Detailed Summary:
Sponsor: Jens Kuhn

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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)


Original Secondary Outcome: Same as current

Information By: University of Cologne

Dates:
Date Received: November 19, 2010
Date Started: January 2011
Date Completion: December 2017
Last Updated: December 6, 2016
Last Verified: December 2016