Deep Brain Stimulation of the Nucleus Accumbens as a Novel Treatment in Severe Opioid Addiction (NASA)
This study is currently recruiting participants.
Verified September 2012 by University of Cologne
Sponsor:
Jens Kuhn
Information provided by (Responsible Party):
Jens Kuhn, University of Cologne
ClinicalTrials.gov Identifier:
NCT01245075
First received: November 19, 2010
Last updated: September 17, 2012
Last verified: September 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Addiction |
Other: Deep brain stimulation Other: Placebo |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Deep Brain Stimulation of the Nucleus Accumbens as a Novel Treatment in Severe Opioid Addiction |
Further study details as provided by University of Cologne:
Primary Outcome Measures:
- Reduction of Levomethadone [ Time Frame: seven month ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- Drug seeking, goal directed behavior, Craving, Psychological components Laboratory parameters in the urine (parallel consumption of other drugs) [ Time Frame: seven month ] [ Designated as safety issue: Yes ]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)
| Estimated Enrollment: | 10 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Deep Brain Stimulation
Stimulator setting is ON
|
Other: Deep brain stimulation
Deep brain stimulation on
|
|
Sham Comparator: Placebo
Stimulator setting is OFF
|
Other: Placebo
deep brain stimulation off
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age > 18 years
- Proficiency in the German language
- Long lasting heroin addiction (fulfilled diagnostic-criteria according to DSM-IV,ICD-10)
- At least one detoxication-treatment without a long-term period of abstinence has already taken place
- Long-term inpatient treatment to support abstinence have occurred
- Free patient's decision / Informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance)
- If prior medication, stable dosage of psychopharmacological drugs over the last three months, which shall, after checking be retained during the study
- Substitution treatment with constant dose within the last three months before study inclusion
Exclusion Criteria:
- Hospitalization by PsychKG
- Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases, severe personality disorder)
- Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator
- Current and in the last six months existent paranoid-hallucinated symptomatology
- Foreign aggressiveness in the last six months
- Verbal IQ < 85 (evaluated with the German Mehrfachauswahl-Intelligenz-Test (MWT-A/B))
- Stereotactic respectively neurosurgical intervention in the past
- Neoplastical neurological diseases
- Contraindications of a stereotactic operation, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)
- Serious and instable organic diseases (e.g. instable coronal heart disease)
- tested positively for HIV
- pregnancy and/or lactation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245075
Contacts
| Contact: Volker Sturm, MD | ++49221-478-4580 | volker.sturm@uk-koeln.de |
| Contact: Jens Kuhn, MD | ++49221-478-4005 | jens.kuhn@uk-koeln.de |
Locations
| Germany | |
| University of Cologne | Recruiting |
| Cologne, Germany, 50924 | |
Sponsors and Collaborators
Jens Kuhn
Investigators
| Principal Investigator: | Volker Sturm, MD | University of Cologne |
| Principal Investigator: | Jens Kuhn, MD | University of Cologne |
More Information
No publications provided
| Responsible Party: | Jens Kuhn, Prof. Dr., University of Cologne |
| ClinicalTrials.gov Identifier: | NCT01245075 History of Changes |
| Other Study ID Numbers: | 10-090 |
| Study First Received: | November 19, 2010 |
| Last Updated: | September 17, 2012 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Behavior, Addictive Compulsive Behavior Impulsive Behavior Analgesics, Opioid Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 16, 2013