CClinicalTrials.gg
CompletedNCT02557815Updated Sep 23, 2015

Changing the Vulnerable Brain: A Neuromodulation Study in Alcohol Dependence

A Phase 3 interventional study of Repetitive Transcranial Magnetic Stimulation in Alcohol Dependence, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Completed. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-23.

Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alcohol Dependence

Browse trials for

Keywords

  • Repetitive Transcranial Magnetic Stimulation
  • Emotion Regulation
  • Craving
03

In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 80 is close to the median of 87 across 1,371 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Alcohol Dependence
  • Currently abstinent

Exclusion criteria

Exclusion Criteria:

  • psychoactive medication
  • not eligible for MRI (metals or claustrophobia)
  • (familial) history of epilepsy
  • current psychiatric disorders (besides alcohol dependence)
05

Study design

Phase
Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Active Repetitive Transcranial Magnetic Stimulation (rTMS)

    Repetitive Transcranial Magnetic Stimulation: Active 10hz stimulation over the right dorsolateral Prefrontal Cortex (dlPFC)

    Device: Repetitive Transcranial Magnetic Stimulation

  • Sham comparator
    Sham stimulation

    Repetitive Transcranial Magnetic Stimulation: sham stimulation over the right dlPFC

    Device: Repetitive Transcranial Magnetic Stimulation

Interventions

  • DeviceRepetitive Transcranial Magnetic Stimulation

    Repetitive 10Hz right DLPFC stimulation using Magstim TMS apparatus

06

What researchers measure

Primary outcomes

  1. Change in BOLD response during an emotion regulation task (fMRI)

    BOLD response was measured during an emotion regulation task. The change in BOLD response between sessions is the primary outcome for this study

    Time frame: Change in BOLD response from baseline, compared to BOLD response after stimulation (approximately two weeks later)

Secondary outcomes

  1. Change in experienced emotion during an emotion regulation task with Visual Analogue Scales (VAS)

    Participants were instructed to either 'attend' or 'regulate' their emotion associated with the presented (negatively valenced) pictures. Experienced (or regulated) emotion was assessed with visual analogue scales (VAS).

    Time frame: Change in experienced emotion from baseline, and after the stimulation session (approximately two weeks later)

  2. Change in craving levels [Alcohol Urge Questionnaire (AUQ)]

    The AUQ was administered in order to assess craving levels. The AUQ consists of eight statements wich are rated on a 7 point likert scale \[0 = Strongly disagree, 6 = Strongly Agree\]

    Time frame: 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)

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 25477246 ↗
  • 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. PubMed 23916527 ↗
  • 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. PubMed 31133889 ↗
  • 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. PubMed 31057439 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02557815
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Responsible party
Anneke E. Goudriaan (Prof. Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)) — Principal investigator
First posted
Sep 23, 2015
Start date
Feb 2012
Primary completion
Oct 2014
Last update
Sep 23, 2015

Study contacts

Anneke E Goudriaan, Prof dr.
principal investigator · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion