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Advancing addiction treatment


- candidate number22419
- NTR NumberNTR5291
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jul-2015
- Secondary IDs2015_064 a rTMS enhanced CBT trial
- Public TitleAdvancing addiction treatment
- Scientific Titleadvancing addiction treatment using neuromodulation: a rTMS-enhanced CBT trial
- ACRONYM
- hypothesisStimulation 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) studiedAlcohol 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2016
- planned closingdate1-nov-2018
- Target number of participants80
- InterventionsOne group will receive rTMS treatment, and the other group will receive sham rTMS treatment.
- Primary outcomeTime to first relapse (heavy drinking day)
- Secondary outcomeSecondary 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
- Timepoints10 executive workdays, thereafter follow-up measurements at 3, 6 and 12 months.
- Trial web sitehttp://verslaving-onderzoek.nl/
- status[default]
- CONTACT FOR PUBLIC QUERIES Renée Schluter
- CONTACT for SCIENTIFIC QUERIESProf. Dr. A. Goudriaan
- Sponsor/Initiator Academic Medical Center (AMC), Department of Psychiatry
- Funding
(Source(s) of Monetary or Material Support)
NWO
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD6-jul-2015 - 27-feb-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl