Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-20 @ 11:18 AM
Study NCT ID:
NCT02862093
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2016-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Magnetic Stimulation in Alcohol Use Disorder
Sponsor:
Catholic University of the Sacred Heart
Organization:
Study Overview
Official Title:
Transcranial Magnetic Stimulation in Alcohol Use Disorder: Effects on Dopamine Transporter and Alcohol Intake
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Repetitive Transcranial Magnetic Stimulation (rTMS) of the dorsolateral prefrontal cortex may affect neuro-adaptations associated with alcohol use disorder (AUD), potentially influencing craving and alcohol intake.
Investigators investigated alcohol intake and dopamine transporter (DAT) availability by Single Photon Emission Computed Tomography (SPECT) in the striatum of AUD patients before and after deep rTMS.
Investigators investigated alcohol intake and dopamine transporter (DAT) availability by Single Photon Emission Computed Tomography (SPECT) in the striatum of AUD patients before and after deep rTMS.
Detailed Description:
The study included AUD patients. Patients were enrolled by the alcohol addiction unit of the Internal Medicine, Gastroenterology and Hepatology Department of the Catholic University in Rome, Italy, according to the inclusion criteria. Screening collection of medical history, physical, neurological and psychiatric examinations as well as laboratory tests were performed. Moreover, patients were underwent to baseline SPECT assessment of striatal DAT availability using 123I-N-ω-fluoropropyl-2β-carbomethoxy-3β-(4-iodophenyl) nortropane (123I-FP-CIT) as the radiotracer. Subsequently, patients were randomized in two groups (matched for gender and age) by a computer program for the REAL deep rTMS or SHAM. After weekly sessions of deep rTMS for four weeks, patients were underwent to the same clinical assessment as in the screening phase and second SPECT .
Moreover, the alcohol intake during both the four weeks prior to the enrollment and the 4 weeks of rTMS sessions were assessed through the Timeline Followback (TLFB) interview, an instrument providing a retrospective estimation of the number of drinks per drinking days, the number of drinking days, the number of abstinence days, the number of heavy drinking days and the total number of drinks. Patients were also evaluated with Alcohol Dependence Scale (ADS), Obsessive Compulsive Drinking Scale (OCDS), State-Trait Anxiety Inventory Scale (STAI Y1 and STAI Y2),Zung Self-Rating Depression Scale.
Moreover, the alcohol intake during both the four weeks prior to the enrollment and the 4 weeks of rTMS sessions were assessed through the Timeline Followback (TLFB) interview, an instrument providing a retrospective estimation of the number of drinks per drinking days, the number of drinking days, the number of abstinence days, the number of heavy drinking days and the total number of drinks. Patients were also evaluated with Alcohol Dependence Scale (ADS), Obsessive Compulsive Drinking Scale (OCDS), State-Trait Anxiety Inventory Scale (STAI Y1 and STAI Y2),Zung Self-Rating Depression Scale.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: