Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02862093 |
Other study ID # |
TMSAlcoholDependeceStudy |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 2010 |
Est. completion date |
August 2015 |
Study information
Verified date |
February 2024 |
Source |
Catholic University of the Sacred Heart |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.