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Transcranial Magnetic Stimulation in Alcohol Use Disorder

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ClinicalTrials.gov Identifier: NCT02862093
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Giovanni Addolorato, Catholic University of the Sacred Heart

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.


Condition or disease Intervention/treatment Phase
Alcohol Dependence Device: Repetitive Transcranial Magnetic Stimulation Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation in Alcohol Use Disorder: Effects on Dopamine Transporter and Alcohol Intake
Study Start Date : January 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Active Comparator: Deep rTMS
The intervention consisted of deep rTMS of dorsolateral prefrontal cortex through the Brainsway Deep TMS System using an H-shaped coil . The motor threshold was measured by delivering a single pulse to the motor cortex. The site of stimulation was located 5.5 cm anterior to the point at which maximum stimulation of the abductor pollicis brevis muscle was reached. Each patient received a total of 12 rTMS sessions (three sessions per week): 20 trains per session at an intensity of 100% of the motor threshold, 50 pulses per train at a frequency of 10 Hertz, an inter-train interval of 15 seconds.
Device: Repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation of the dorsolateral prefrontal cortex

Placebo Comparator: Placebo
The sham stimulation consisted of rTMS sessions without an effective instrument operation.
Device: Repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation of the dorsolateral prefrontal cortex




Primary Outcome Measures :
  1. Change From Baseline in Dopamine Transporter availability in the striatum throgh Single Photon Emission Computed Tomography (SPECT) [ Time Frame: Week 4 ]

Secondary Outcome Measures :
  1. Change From Baseline in alcohol intake [ Time Frame: Week 4 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least two days a week of excessive alcohol consumption during the month prior to screening;
  • Ability to provide informed consent;
  • A Clinical Institute of Withdrawal Assessment in Alcohol Withdrawal score < 10;
  • Willingness to abstain from or substantially reduce alcohol consumption;
  • Permanent residence.

Exclusion Criteria:

  • Clinically significant psychiatric diseases;
  • Past or current abuse or dependence on substances other than alcohol or nicotine;
  • Neurological disorders;
  • Unstable medical conditions;
  • Pacemakers, implanted metallic pumps, metal implant;
  • History of complicated withdrawal symptoms;
  • Current use of psychoactive drugs;
  • Epilepsy;
  • Current use of anticonvulsants, insulin or oral hypoglycemic agents;
  • Positive urine toxicological screening;
  • Pregnancy;
  • Participation in other clinical trial in the last 60 days;
  • Involvement in a compulsory medical treatment or pending criminal proceedings.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862093


Locations
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Italy
Catholic University of Rome
Rome, Rm, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
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Principal Investigator: Giovanni Addolorato Department of Internal Medicine, Catholic University of Rome, Italy

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Responsible Party: Giovanni Addolorato, Professor of Internal Medicine, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02862093     History of Changes
Other Study ID Numbers: TMSAlcoholDependeceStudy
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders