Clinical trial NCT01973127: Transcranial Magnetic Stimulation in the Treatment of Addiction
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) in Alcohol Dependent Patients: a Mechanistic Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Addiction
Keywords: alcohol
addiction
TMS
craving
use
rTMS
EEG
LPP
p300
ERN
SST
CCT
AAAT
Lead sponsor: IrisZorg
Sponsor class: OTHER
First posted: 2013-10-31
Enrollment: 30
Sex: MALE
Minimum age (years): 23
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that repetitive transcranial magnetic stimulation (rTMS) on the right side of the head will make craving towards alcohol less severe in recently detoxified alcohol addicted patients.

Although there are successful treatment option to detoxify patients form their alcohol use, many patients tend to relapse. This relapse is mainly caused by a high level of (uncontrollable) craving towards alcohol. This aspect of addiction is with the existing options hard to treat, there is a great need of new successful treatment modalities. rTMS is a FDA approved treatment method for depression. Recently some small scale studies have shown promising results on rTMS in the treatment of addiction. In this study the investigators focus on alcohol addiction since it is the addiction with the highest morbidity and mortality in the Netherlands.

Detailed description: In this study the investigators focus on three levels of interest: the biological level, the functional level and the clinical level. The investigators will measure the effect of rTMS directly on brain activity through EEG recording. The investigators investigate its effects on cognitive performance through the use of neuropsychological computer tasks. The investigators will address clinical behavior (craving and alcohol use) with questionnaires.

Eligibility criteria: Inclusion Criteria:

* Right-handed males between 23-65 years of age
* A primary diagnose of alcohol dependence (meeting the DSM-IV-TR criteria 303.90/ICD-10 F10.2)
* Written consent for participation of the study.

Exclusion Criteria:

* MATE outcome \<4 (as extracted from part 4 MATE at enrollment phase)MATE= Dutch screening instrument on (among others) addiction severity
* Presence of a current or past relevant somatic or neurological disorder
* Meeting the DSM-IV-TR criteria for a current bipolar disorder, schizophrenia, anxiety disorder or moderate to severe depressive disorder. These disorders would be a possible great confounder. Measured with the MINI-plus.
* Meeting the DSM-IV-TR criteria for current (in the past 2 weeks) dependence of substances other than alcohol, nicotine or caffeine. Information present in MATE.
* Participant-bound factors that may endanger participants or may jeopardize study adherence, because of failure to understand and/or comply with instructions (e.g. current, disruptive symptoms such as psychotic symptoms or severe cognitive impairment)
* Contra-indications resulting from the use of rTMS:

  * Epilepsy, convulsion or seizure
  * Serious head trauma or brain surgery
  * Large or ferromagnetic metal parts in the head (except for a dental wire)
  * Implanted cardiac pacemaker or neurostimulator

Primary outcomes:
measure: The change from baseline on the amplitude of the LPP at 8 weeks
timeFrame: 8 weeks after start of treatment.
Secondary outcomes:
measure: The change from baseline on the amplitude of the LPP at 2 weeks
timeFrame: 2 weeks after start of treatment
measure: The change from baseline on the amplitude of the LPP at 4 weeks
timeFrame: 4 weeks after start of treatment
measure: The change from baseline on the amplitude of the LPP at 12 weeks
timeFrame: 12 weeks after start of treatment
measure: The change from baseline on the amplitude of the ERN at 2 weeks
timeFrame: 2 weeks after start of treatment
measure: The change from baseline on the amplitude of the ERN at 4 weeks
timeFrame: 4 weeks after start of treatment
measure: The change from baseline on the amplitude of the ERN at 8 weeks
timeFrame: 8 weeks after start of treatment
measure: The change from baseline on the amplitude of the ERN at 12 weeks
timeFrame: 12 weeks after start of treatment
measure: Change from baseline on SST at 2 weeks
timeFrame: at 2 weeks after start treatement
measure: Change from baseline on SST at 4 weeks
timeFrame: at 4 weeks after start treatement
measure: Change from baseline on SST at 8 weeks
timeFrame: at 8 weeks after start treatement
measure: Change from baseline on SST at 12 weeks
timeFrame: at 12 weeks after start treatement
measure: Change from baseline on CCT at 2 weeks
timeFrame: at 2 weeks after start treatement
measure: Change from baseline on CCT at 4 weeks
timeFrame: at 4 weeks after start treatement
measure: Change from baseline on CCT at 8 weeks
timeFrame: at 8 weeks after start treatement
measure: Change from baseline on CCT at 12 weeks
timeFrame: at 12 weeks after start treatement
measure: Change from baseline on AAAT at 2 weeks
timeFrame: at 2 weeks after start treatement
measure: Change from baseline on AAAT at 4 weeks
timeFrame: at 4 weeks after start treatement
measure: Change from baseline on AAAT at 8 weeks
timeFrame: at 8 weeks after start treatement
measure: Change from baseline on AAAT at 12 weeks
timeFrame: at 12 weeks after start treatement
measure: Change form baseline on craving at 2 weeks after start treatment
timeFrame: at 2 weeks after start treatment
measure: Change form baseline on craving at 4 weeks after start treatment
timeFrame: at 4 weeks after start treatment
measure: Change form baseline on craving at 8 weeks after start treatment
timeFrame: at 8 weeks after start treatment
measure: Change form baseline on craving at 12 weeks after start treatment
timeFrame: at 12 weeks after start treatment
measure: Change form baseline on alcohol use at 2 weeks after start treatment
timeFrame: at 2 weeks after start treatment
measure: Change form baseline on alcohol use at 4 weeks after start treatment
timeFrame: at 4 weeks after start treatment
measure: Change form baseline on alcohol use at 12 weeks after start treatment
timeFrame: at 8 weeks after start treatment
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: IrisZorg
state: Gelderland
Study officials:
affiliation: IrisZorg
name: Maarten Belgers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feil J, Zangen A. Brain stimulation in the study and treatment of addiction. Neurosci Biobehav Rev. 2010 Mar;34(4):559-74. doi: 10.1016/j.neubiorev.2009.11.006. Epub 2009 Nov 13.
citation: Barr MS, Farzan F, Wing VC, George TP, Fitzgerald PB, Daskalakis ZJ. Repetitive transcranial magnetic stimulation and drug addiction. Int Rev Psychiatry. 2011 Oct;23(5):454-66. doi: 10.3109/09540261.2011.618827.
citation: Amiaz R, Levy D, Vainiger D, Grunhaus L, Zangen A. Repeated high-frequency transcranial magnetic stimulation over the dorsolateral prefrontal cortex reduces cigarette craving and consumption. Addiction. 2009 Apr;104(4):653-60. doi: 10.1111/j.1360-0443.2008.02448.x. Epub 2009 Jan 12.