search
Back to results

Transcranial Magnetic Stimulation in Alcohol Use Disorder

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)Does not accept healthy volunteers

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.

Sites / Locations

  • Catholic University of Rome

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Deep rTMS

Placebo

Arm Description

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.

The sham stimulation consisted of rTMS sessions without an effective instrument operation.

Outcomes

Primary Outcome Measures

Change From Baseline in Dopamine Transporter availability in the striatum throgh Single Photon Emission Computed Tomography (SPECT)

Secondary Outcome Measures

Change From Baseline in alcohol intake

Full Information

First Posted
August 3, 2016
Last Updated
August 10, 2016
Sponsor
Catholic University of the Sacred Heart
search

1. Study Identification

Unique Protocol Identification Number
NCT02862093
Brief Title
Transcranial Magnetic Stimulation in Alcohol Use Disorder
Official Title
Transcranial Magnetic Stimulation in Alcohol Use Disorder: Effects on Dopamine Transporter and Alcohol Intake
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep rTMS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The sham stimulation consisted of rTMS sessions without an effective instrument operation.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Intervention Description
Repetitive Transcranial Magnetic Stimulation of the dorsolateral prefrontal cortex
Primary Outcome Measure Information:
Title
Change From Baseline in Dopamine Transporter availability in the striatum throgh Single Photon Emission Computed Tomography (SPECT)
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Change From Baseline in alcohol intake
Time Frame
Week 4

10. Eligibility

Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Addolorato
Organizational Affiliation
Department of Internal Medicine, Catholic University of Rome, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University of Rome
City
Rome
State/Province
Rm
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Transcranial Magnetic Stimulation in Alcohol Use Disorder

We'll reach out to this number within 24 hrs