|- candidate number||22419|
|- NTR Number||NTR5291|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-jul-2015|
|- Secondary IDs||2015_064 a rTMS enhanced CBT trial|
|- Public Title||Advancing addiction treatment|
|- Scientific Title||advancing addiction treatment using neuromodulation: a rTMS-enhanced CBT trial|
|- hypothesis||Stimulation of the right DLPFC of alcohol dependent patients will decrease self-reported craving and recude relapse rates. Furthermore it will increase behavioral control and normalize brain activation patterns. |
|- Healt Condition(s) or Problem(s) studied||Alcohol dependence, fMRI|
|- Inclusion criteria||- Men and women.|
- Age between 25-65.
- Recent DSM-V diagnosis (mild, moderate and severe) of alcohol use disorder (<4 months after detox).
- Currently in treatment (>2 weeks after detox) and will be in treatment during the entire stimulation period (2 weeks after inclusion).
- Sufficient speaking and understanding of Dutch language.
|- Exclusion criteria||- A DSM-V diagnosis of schizophrenia or another psychotic disorder, personality disorder or sleep disorder.|
- TMS contraindications: history of epileptic seizures or epilepsy in a first degree relative, irregular sleep/ wake rhythm.
- MR contraindications (only relevant for the 40 participants who will undergo MR scanning): metal implants, claustrophobia.
- No drug use during the treatment process other than drugs prescribed by their practitioner in order to overcome their alcohol dependence.
- IQ under 80
- Endocrinological disorders or regular use of corticosteroids.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2016|
|- planned closingdate||1-nov-2018|
|- Target number of participants||80|
|- Interventions||One group will receive rTMS treatment, and the other group will receive sham rTMS treatment.|
|- Primary outcome||Time to first relapse (heavy drinking day)|
|- Secondary outcome||Secondary outcomes are changes in craving (immediately after 2-week rTMS treatment; at 3-months and at 6-months and 12-months past treatment; changes in SST, AAT (cognitive tasks), and changes in (f)MRI measures immediately after rTMS treatment |
|- Timepoints||10 executive workdays, thereafter follow-up measurements at 3, 6 and 12 months. |
|- Trial web site||http://verslaving-onderzoek.nl/|
|- CONTACT FOR PUBLIC QUERIES|| Renée Schluter|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. A. Goudriaan|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Psychiatry|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||6-jul-2015 - 27-feb-2016|