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Advancing addiction treatment using neuromodulation: a rTMS enhanced CBT trial

Advancing addiction treatment using neuromodulation: a rTMS enhanced CBT trial - Advancing addiction treatment

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47612
Enrollment
80
Registered
2015-06-12
Start date
2016-02-09
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

alcoholverslaving alcohol addiction Alcohol dependence

Interventions

One group will receive rTMS treatment, and the other group will receive sham rTMS treatment.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 (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: 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.

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)