NCT02862093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

3.1 years

First QC Date

August 3, 2016

Last Update Submit

February 6, 2024

Conditions

Alcohol Dependence

Outcome Measures

Primary Outcomes (1)

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

    Week 4

Secondary Outcomes (1)

  • Change From Baseline in alcohol intake

    Week 4

Study Arms (2)

Deep rTMS

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic StimulationDEVICE

Repetitive Transcranial Magnetic Stimulation of the dorsolateral prefrontal cortex

Deep rTMSPlacebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Rome

Rome, Rm, 00168, Italy

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Giovanni Addolorato

    Department of Internal Medicine, Catholic University of Rome, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 10, 2016

Study Start

January 1, 2010

Primary Completion

February 1, 2013

Study Completion

August 1, 2015

Last Updated

February 8, 2024

Record last verified: 2024-02

Locations

IT(1)