Alcohol AddictionMAGENTANCT01973127
Transcranial Magnetic Stimulation in the Treatment of Addiction
A study testing Verum rTMS in people with Alcohol Addiction, run by IrisZorg at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 65 years, men only
- Conditions the study is for
- Alcohol Addiction
- What is being tested?
- Verum rTMS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Ant Schellekens, MD, PhD contact
About this study
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) in Alcohol Dependent Patients: a Mechanistic Study.
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.
Read the 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.
- Conditions
- Alcohol Addiction
- Being tested
- Verum rTMS, Sham rTMS
- Keywords
- alcohol, addiction, TMS, craving, use, rTMS, EEG, LPP, p300, ERN, SST, CCT, AAAT
- Medical subject headings
- Alcoholism, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum rTMSOther
rTMS on the right dorsolateral prefrontal cortex. TMS procedure: The resting motor threshold (RMT) will be defined in each subject as the minimal stimulation intensity evoking an MEP of ≥ 0.05 mV in 50% of the trials in the muscle of the right thumb (M. abductor pollicis brevis). TMS will be conducted in the form of 'conventional rTMS', whereby 30 trains of 10 Hz pulses with a duration of 5 seconds and an inter-train interval of 25 seconds are applied to the righ dorsolateral prefrontal cortex (50 pulses per train, 6000 pulses per session). Used equipment: Magstim Rapid 2 device.
Sham rTMSOther
TMS procedure: The resting motor threshold (RMT) will be defined in each subject as the minimal stimulation intensity evoking an MEP of ≥ 0.05 mV in 50% of the trials in the muscle of the right thumb (M. abductor pollicis brevis). Like in verum TMS coil will be placed on the skull, but no magnetic field will be pulsed. Used equipment: Magstim Rapid 2 device.
| Study group | Role | What they receive |
|---|---|---|
| Verum rTMS | Experimental | n=15. After detoxification of alcohol (maximum 4 days) rTMS treatment will start : 20 sessions (5 times during 4 weeks)of verum rTMS on the right dorsolateral prefrontal cortex.
Measurements of all objectives at baseline and 2,4,8 and 12 weeks after start treatment. Receives: Other: Verum rTMS |
| Sham TMS | Sham comparator | n=15. After detoxification of alcohol (maximum 4 days) rTMS treatment will start : 20 sessions (5 times during 4 weeks)of sham rTMS on the right dorsolateral prefrontal cortex.
Measurements of all objectives at basleine and 2,4,8 and 12 weeks after start treatment. Receives: Other: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline on the amplitude of the LPP at 8 weeks
To investigate the effect of 20 sessions of rTMS on the change in amplitude of the Late Positive Potentials (LPP) (P300 and Slow Potential (SP)) as measured with EEG at 8 weeks after start of treatment (baseline measurement).
Measured: 8 weeks after start of treatment.
Secondary outcomes (26)
The change from baseline on the amplitude of the LPP at 2 weeks
To investigate the effect of 20 sessions of rTMS on the change in amplitude of the Late Positive Potentials (LPP) (P300 and Slow Potential (SP)) as measured with EEG at 2 weeks after start of treatment (baseline measurement).
Measured: 2 weeks after start of treatment
The change from baseline on the amplitude of the LPP at 4 weeks
To investigate the effect of 20 sessions of rTMS on the change in amplitude of the Late Positive Potentials (LPP) (P300 and Slow Potential (SP)) as measured with EEG at 4 weeks after start of treatment (baseline measurement).
Measured: 4 weeks after start of treatment
The change from baseline on the amplitude of the LPP at 12 weeks
To investigate the effect of 20 sessions of rTMS on the change in amplitude of the Late Positive Potentials (LPP) (P300 and Slow Potential (SP)) as measured with EEG at 12 weeks after start of treatment (baseline measurement).
Measured: 12 weeks after start of treatment
The change from baseline on the amplitude of the ERN at 2 weeks
To investigate the effect of 20 sessions of rTMS on the change in amplitude of the Error Related Negativity (ERN) as measured with EEG at 2 weeks after start of treatment (baseline measurement).
Measured: 2 weeks after start of treatment
The change from baseline on the amplitude of the ERN at 4 weeks
To investigate the effect of 20 sessions of rTMS on the change in amplitude of the Error Related Negativity (ERN) as measured with EEG at 4 weeks after start of treatment (baseline measurement).
Measured: 4 weeks after start of treatment
The change from baseline on the amplitude of the ERN at 8 weeks
To investigate the effect of 20 sessions of rTMS on the change in amplitude of the Error Related Negativity (ERN) as measured with EEG at 8 weeks after start of treatment (baseline measurement).
Measured: 8 weeks after start of treatment
The change from baseline on the amplitude of the ERN at 12 weeks
To investigate the effect of 20 sessions of rTMS on the change in amplitude of the Error Related Negativity (ERN) as measured with EEG at 12 weeks after start of treatment (baseline measurement).
Measured: 12 weeks after start of treatment
Change from baseline on SST at 2 weeks
To investigate the effect of 20 sessions of rTMS on the change in cognitive performance at 2 weeks follow-up, by conducting a Stop-Signal Task (SST)per computer.
Measured: at 2 weeks after start treatement
Change from baseline on SST at 4 weeks
To investigate the effect of 20 sessions of rTMS on the change in cognitive performance at 4 weeks follow-up, by conducting a Stop-Signal Task (SST)per computer.
Measured: at 4 weeks after start treatement
Change from baseline on SST at 8 weeks
To investigate the effect of 20 sessions of rTMS on the change in cognitive performance at 12 weeks follow-up, by conducting a Stop-Signal Task (SST) per computer.
Measured: at 8 weeks after start treatement
Change from baseline on SST at 12 weeks
To investigate the effect of 20 sessions of rTMS on the change in cognitive performance at 12 weeks follow-up, by conducting a Stop-Signal Task (SST) per computer.
Measured: at 12 weeks after start treatement
Change from baseline on CCT at 2 weeks
To investigate the effect of 20 sessions of rTMS on the change in cognitive performance at 2 weeks follow-up, by conducting a Columbia Card Task (CCT) per computer.
Measured: at 2 weeks after start treatement
Change from baseline on CCT at 4 weeks
To investigate the effect of 20 sessions of rTMS on the change in cognitive performance at 4 weeks follow-up, by conducting a Columbia Card Task (CCT) per computer.
Measured: at 4 weeks after start treatement
Change from baseline on CCT at 8 weeks
To investigate the effect of 20 sessions of rTMS on the change in cognitive performance at 8 weeks follow-up, by conducting a Columbia Card Task (CCT) per computer.
Measured: at 8 weeks after start treatement
Change from baseline on CCT at 12 weeks
To investigate the effect of 20 sessions of rTMS on the change in cognitive performance at 12 weeks follow-up, by conducting a Columbia Card Task (CCT) per computer.
Measured: at 12 weeks after start treatement
Change from baseline on AAAT at 2 weeks
To investigate the effect of 20 sessions of rTMS on the change in cognitive performance at 2 weeks follow-up, by conducting a Alcohol Approach Avoidance Task (AAAT) per computer.
Measured: at 2 weeks after start treatement
Change from baseline on AAAT at 4 weeks
To investigate the effect of 20 sessions of rTMS on the change in cognitive performance at 4 weeks follow-up, by conducting a Alcohol Approach Avoidance Task (AAAT) per computer.
Measured: at 4 weeks after start treatement
Change from baseline on AAAT at 8 weeks
To investigate the effect of 20 sessions of rTMS on the change in cognitive performance at 8 weeks follow-up, by conducting a Alcohol Approach Avoidance Task (AAAT) per computer.
Measured: at 8 weeks after start treatement
Change from baseline on AAAT at 12 weeks
To investigate the effect of 20 sessions of rTMS on the change in cognitive performance at 12 weeks follow-up, by conducting a Alcohol Approach Avoidance Task (AAAT) per computer.
Measured: at 12 weeks after start treatement
Change form baseline on craving at 2 weeks after start treatment
To investigate the change of 20 sessions of rTMS in perceived patient reported craving at 2 weeks after start treatment as measured with the Obsessive Compulsing Drinking Scale (OCDS), Alcohol Urge Questionnaire (AUQ) and a craving Visual Analogue Scale (VAS).
Measured: at 2 weeks after start treatment
Change form baseline on craving at 4 weeks after start treatment
To investigate the change of 20 sessions of rTMS in perceived patient reported craving at 4 weeks after start treatment as measured with the Obsessive Compulsing Drinking Scale (OCDS), Alcohol Urge Questionnaire (AUQ) and a craving Visual Analogue Scale (VAS).
Measured: at 4 weeks after start treatment
Change form baseline on craving at 8 weeks after start treatment
To investigate the change of 20 sessions of rTMS in perceived patient reported craving at 8 weeks after start treatment as measured with the Obsessive Compulsing Drinking Scale (OCDS), Alcohol Urge Questionnaire (AUQ) and a craving Visual Analogue Scale (VAS).
Measured: at 8 weeks after start treatment
Change form baseline on craving at 12 weeks after start treatment
To investigate the change of 20 sessions of rTMS in perceived patient reported craving at 12 weeks after start treatment as measured with the Obsessive Compulsing Drinking Scale (OCDS), Alcohol Urge Questionnaire (AUQ) and a craving Visual Analogue Scale (VAS).
Measured: at 12 weeks after start treatment
Change form baseline on alcohol use at 2 weeks after start treatment
To investigate the effect of 20 sessions of rTMS on the change in alcohol use 2 weeks from baseline by filling in a dairy on treatment days 5 times a week.
Measured: at 2 weeks after start treatment
Change form baseline on alcohol use at 4 weeks after start treatment
To investigate the effect of 20 sessions of rTMS on the change in alcohol use 4 weeks from baseline by filling in a dairy on treatment days 5 times a week.
Measured: at 4 weeks after start treatment
Change form baseline on alcohol use at 12 weeks after start treatment
To investigate the effect of 20 sessions of rTMS on the change in alcohol use 12 weeks from baseline by using the Alcohol Timeline Follow Back (TLFB) method.
Measured: at 8 weeks after start treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startMay 2014
- Primary completionApr 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IrisZorg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maarten Belgers, MD, Principal investigator, IrisZorg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973127
- Sponsor's protocol ID
- NISPA-IZ/MB22
- Acronym
- MAGENTA
- Status last verified
- Oct 2013
- First submitted
- 22 Oct 2013
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19914283Barr 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.
PubMed 22200135Amiaz 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.
PubMed 19183128Belgers M, Markus W, Grasso F, Arns M, Van Eijndhoven P, Schellekens A. No Effects of rTMS on Performance Monitoring and Attentional Bias in Patients With Alcohol Use Disorder: A Pilot Study. Addict Biol. 2025 Nov;30(11):e70100. doi: 10.1111/adb.70100.
PubMed 41253702
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation (rTMS) in Alcohol Dependent Patients: a Mechanistic Study.
- ClinicalTrials.gov ID
- NCT01973127
- Acronym / sponsor ID
- MAGENTA / NISPA-IZ/MB22
- Conditions
- Alcohol Addiction
- Keywords
- alcohol, addiction, TMS, craving, use, rTMS, EEG, LPP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IrisZorgUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum rTMS | Experimental | Other: Verum rTMSn=15. After detoxification of alcohol (maximum 4 days) rTMS treatment will start : 20 sessions (5 times during 4 weeks)of verum rTMS on the right dorsolateral prefrontal cortex. Measurements of all objectives at baseline and 2,4,8 and 12 weeks after start treatment. |
| Sham TMS | Sham comparator | Other: Sham rTMSn=15. After detoxification of alcohol (maximum 4 days) rTMS treatment will start : 20 sessions (5 times during 4 weeks)of sham rTMS on the right dorsolateral prefrontal cortex. Measurements of all objectives at basleine and 2,4,8 and 12 weeks after start treatment. |
Who may qualify
- Ages
- 23 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verum rTMSrTMS on the right dorsolateral prefrontal cortex. TMS procedure: The resting motor threshold (RMT) will be defined in each subject as the minimal stimulation intensity evoking an MEP of ≥ 0.05 mV in 50% of the trials in the muscle of the right thumb (M. abductor pollicis brevis). TMS will be conducted in the form of 'conventional rTMS', whereby 30 trains of 10 Hz pulses with a duration of 5 seconds and an inter-train interval of 25 seconds are applied to the righ dorsolateral prefrontal cortex (50 pulses per train, 6000 pulses per session). Used equipment: Magstim Rapid 2 device. | Other | Verum rTMS |
| Sham rTMSTMS procedure: The resting motor threshold (RMT) will be defined in each subject as the minimal stimulation intensity evoking an MEP of ≥ 0.05 mV in 50% of the trials in the muscle of the right thumb (M. abductor pollicis brevis). Like in verum TMS coil will be placed on the skull, but no magnetic field will be pulsed. Used equipment: Magstim Rapid 2 device. | Other | Sham TMS |
Primary outcome
The change from baseline on the amplitude of the LPP at 8 weeks
Time frame: 8 weeks after start of treatment.
To investigate the effect of 20 sessions of rTMS on the change in amplitude of the Late Positive Potentials (LPP) (P300 and Slow Potential (SP)) as measured with EEG at 8 weeks after start of treatment (baseline measurement).
26 secondary outcomes
The change from baseline on the amplitude of the LPP at 2 weeks
Time frame: 2 weeks after start of treatment
The change from baseline on the amplitude of the LPP at 4 weeks
Time frame: 4 weeks after start of treatment
The change from baseline on the amplitude of the LPP at 12 weeks
Time frame: 12 weeks after start of treatment
The change from baseline on the amplitude of the ERN at 2 weeks
Time frame: 2 weeks after start of treatment
The change from baseline on the amplitude of the ERN at 4 weeks
Time frame: 4 weeks after start of treatment
The change from baseline on the amplitude of the ERN at 8 weeks
Time frame: 8 weeks after start of treatment
The change from baseline on the amplitude of the ERN at 12 weeks
Time frame: 12 weeks after start of treatment
Change from baseline on SST at 2 weeks
Time frame: at 2 weeks after start treatement
Change from baseline on SST at 4 weeks
Time frame: at 4 weeks after start treatement
Change from baseline on SST at 8 weeks
Time frame: at 8 weeks after start treatement
Change from baseline on SST at 12 weeks
Time frame: at 12 weeks after start treatement
Change from baseline on CCT at 2 weeks
Time frame: at 2 weeks after start treatement
Change from baseline on CCT at 4 weeks
Time frame: at 4 weeks after start treatement
Change from baseline on CCT at 8 weeks
Time frame: at 8 weeks after start treatement
Change from baseline on CCT at 12 weeks
Time frame: at 12 weeks after start treatement
Change from baseline on AAAT at 2 weeks
Time frame: at 2 weeks after start treatement
Change from baseline on AAAT at 4 weeks
Time frame: at 4 weeks after start treatement
Change from baseline on AAAT at 8 weeks
Time frame: at 8 weeks after start treatement
Change from baseline on AAAT at 12 weeks
Time frame: at 12 weeks after start treatement
Change form baseline on craving at 2 weeks after start treatment
Time frame: at 2 weeks after start treatment
Change form baseline on craving at 4 weeks after start treatment
Time frame: at 4 weeks after start treatment
Change form baseline on craving at 8 weeks after start treatment
Time frame: at 8 weeks after start treatment
Change form baseline on craving at 12 weeks after start treatment
Time frame: at 12 weeks after start treatment
Change form baseline on alcohol use at 2 weeks after start treatment
Time frame: at 2 weeks after start treatment
Change form baseline on alcohol use at 4 weeks after start treatment
Time frame: at 4 weeks after start treatment
Change form baseline on alcohol use at 12 weeks after start treatment
Time frame: at 8 weeks after start treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
- Background: PubMed 19914283Feil 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.
- Background: PubMed 22200135Barr 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.
- Background: PubMed 19183128Amiaz 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.
- Derived from this study: PubMed 41253702Belgers M, Markus W, Grasso F, Arns M, Van Eijndhoven P, Schellekens A. No Effects of rTMS on Performance Monitoring and Attentional Bias in Patients With Alcohol Use Disorder: A Pilot Study. Addict Biol. 2025 Nov;30(11):e70100. doi: 10.1111/adb.70100.
- site of addiction care organisation and sponsorLink provided by the sponsor.
- site of university hospital where treatment takes placeLink provided by the sponsor.
- scientific institute related to the studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ant Schellekens, MD, PhD contact
Maarten Belgers, MD principal investigator
IrisZorg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum rTMS in people with Alcohol Addiction, run by IrisZorg at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maarten Belgers, MD (+31-88-606- 1600, m.belgers@iriszorg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline on the amplitude of the LPP at 8 weeks (time frame: 8 weeks after start of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01973127, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2013.