Clinical trial NCT02557815: Changing the Vulnerable Brain: A Neuromodulation Study in Alcohol Dependence
Official title: Changing the Vulnerable Brain: A Neuromodulation Study in Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol Dependence
Keywords: Repetitive Transcranial Magnetic Stimulation
Emotion Regulation
Craving
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This current project investigates the effect of a single session of right dlPFC repetitive transcranial magnetic stimulation on emotion regulation abilities and craving in alcohol dependent patients and healthy controls.


Eligibility criteria: Inclusion Criteria:

* Alcohol Dependence
* Currently abstinent

Exclusion Criteria:

* psychoactive medication
* not eligible for MRI (metals or claustrophobia)
* (familial) history of epilepsy
* current psychiatric disorders (besides alcohol dependence)

Primary outcomes:
measure: Change in BOLD response during an emotion regulation task (fMRI)
timeFrame: Change in BOLD response from baseline, compared to BOLD response after stimulation (approximately two weeks later)
Secondary outcomes:
measure: Change in experienced emotion during an emotion regulation task with Visual Analogue Scales (VAS)
timeFrame: Change in experienced emotion from baseline, and after the stimulation session (approximately two weeks later)
measure: Change in craving levels [Alcohol Urge Questionnaire (AUQ)]
timeFrame: Before and after the emotion regulation task, during both baseline and stimulation session (e.g. 4 time points, sessions were separated by approximately two weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Anneke E Goudriaan, Prof dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jansen JM, van Holst RJ, van den Brink W, Veltman DJ, Caan MW, Goudriaan AE. Brain function during cognitive flexibility and white matter integrity in alcohol-dependent patients, problematic drinkers and healthy controls. Addict Biol. 2015 Sep;20(5):979-89. doi: 10.1111/adb.12199. Epub 2014 Dec 5.
citation: Jansen JM, Daams JG, Koeter MW, Veltman DJ, van den Brink W, Goudriaan AE. Effects of non-invasive neurostimulation on craving: a meta-analysis. Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 2):2472-80. doi: 10.1016/j.neubiorev.2013.07.009. Epub 2013 Jul 31.
citation: Jansen JM, van den Heuvel OA, van der Werf YD, de Wit SJ, Veltman DJ, van den Brink W, Goudriaan AE. The Effect of High-Frequency Repetitive Transcranial Magnetic Stimulation on Emotion Processing, Reappraisal, and Craving in Alcohol Use Disorder Patients and Healthy Controls: A Functional Magnetic Resonance Imaging Study. Front Psychiatry. 2019 May 7;10:272. doi: 10.3389/fpsyt.2019.00272. eCollection 2019.
citation: Jansen JM, van den Heuvel OA, van der Werf YD, de Wit SJ, Veltman DJ, van den Brink W, Goudriaan AE. Emotion Processing, Reappraisal, and Craving in Alcohol Dependence: A Functional Magnetic Resonance Imaging Study. Front Psychiatry. 2019 Apr 9;10:227. doi: 10.3389/fpsyt.2019.00227. eCollection 2019.