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Completed

NCT Number: NCT02862093

Transcranial Magnetic Stimulation in Alcohol Use Disorder

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Rome

Rome, Rm, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

Repetitive Transcranial Magnetic Stimulation of the dorsolateral prefrontal cortex

Primary outcomes

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

    Time frame: Week 4

Secondary outcomes

  1. Change From Baseline in alcohol intake

    Time frame: Week 4

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

Transcranial Magnetic Stimulation in Alcohol Use Disorder: Effects on Dopamine Transporter and Alcohol Intake

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
Aug 10, 2016
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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