Addiction
Conditions
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.
Interventions
OTHERDeep brain stimulation
Deep brain stimulation on
OTHERPlacebo
deep brain stimulation off
Sponsors
Jens Kuhn
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Levomethadone | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug seeking, goal directed behavior, Craving, Psychological components Laboratory parameters in the urine (parallel consumption of other drugs) | 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) |
Countries
Germany
Contacts
Primary ContactJens Kuhn, MD
Backup ContactVeerle Visser-Vandewalle, MD
Outcome results
None listed