Advancing addiction treatment using neuromodulation: a rTMS enhanced CBT trial

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

The recruitment of participants will take place as follows. Practitioners at
Jellinek will inform patients about our study and we will give presentations at
Jellinek to inform patients about this study. If somebody is willing to
participate in the study, we will personally visit them at Jellinek and explain
the entire procedure. Furthermore they will receive an information letter by
email to make sure they can read the information again carefully. If they are
still interested in participation they will sign informed consent and we will
perform screening for inclusion and exclusion criteria. Demographics,
psychiatric disorders (MINI), TMS contraindications and MR contraindications
are questioned to make sure that the individual can participate.
If a participant meets any of the exclusion criteria that they are excluded
from participation in this study. , Inclusion criteria
- Men and women.
- Age between 25-65.
- Recent DSM-V diagnosis (mild, moderate and severe) of alcohol abuse (<4
months after detox).
- Currently in treatment (>3 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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- In the clinical trial the main study parameter is self-reported level of<br /><br>craving as measured by the alcohol urge questionnaire (AUQ).<br /><br>- In the neurobiological trial the main study parameters are baseline brain<br /><br>activity patterns during fMRI session in comparison to brain activity patterns<br /><br>after ten rTMS sessions (within subject comparison). These differences in brain<br /><br>activity patterns will also be assessed between the sham rTMS stimulation group<br /><br>and the real rTMS stimulation group. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- In the clinical trial the secondary study parameters are relapse into alcohol<br /><br>dependence, changes in measures of impulsivity and compulsivity and changes in<br /><br>obsessive and compulsive behaviour. Furthermore changes in neuropsychological<br /><br>reporting will be used as study parameters.<br /><br>- In the neurobiological trial the secondary study parameters are correlations<br /><br>of brain activity patterns with behavioural and neuropsychological<br /><br>measurements. </p><br>