Alcohol DependenceNCT02862093
Transcranial Magnetic Stimulation in Alcohol Use Disorder
A study testing Repetitive Transcranial Magnetic Stimulation in people with Alcohol Dependence, run by Catholic University of the Sacred Heart at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Magnetic Stimulation in Alcohol Use Disorder: Effects on Dopamine Transporter and Alcohol Intake
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.
Read the 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.
- Conditions
- Alcohol Dependence
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Repetitive Transcranial Magnetic Stimulation of the dorsolateral prefrontal cortex
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| Placebo | Placebo comparator | The sham stimulation consisted of rTMS sessions without an effective instrument operation. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Dopamine Transporter availability in the striatum throgh Single Photon Emission Computed Tomography (SPECT)
Measured: Week 4
Secondary outcomes (1)
Change From Baseline in alcohol intake
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startJan 2010
- Primary completionFeb 2013
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Addolorato, Catholic University of the Sacred Heart
- Investigators
- Giovanni Addolorato, Principal investigator, Department of Internal Medicine, Catholic University of Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862093
- Sponsor's protocol ID
- TMSAlcoholDependeceStudy
- Status last verified
- Feb 2024
- First submitted
- 3 Aug 2016
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation in Alcohol Use Disorder: Effects on Dopamine Transporter and Alcohol Intake
- ClinicalTrials.gov ID
- NCT02862093
- Acronym / sponsor ID
- TMSAlcoholDependeceStudy
- Conditions
- Alcohol Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep rTMS | Active comparator | Device: Repetitive Transcranial Magnetic StimulationThe 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. |
| Placebo | Placebo comparator | Device: Repetitive Transcranial Magnetic StimulationThe sham stimulation consisted of rTMS sessions without an effective instrument operation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationRepetitive Transcranial Magnetic Stimulation of the dorsolateral prefrontal cortex | Device | Deep rTMS, Placebo |
Primary outcome
Change From Baseline in Dopamine Transporter availability in the striatum throgh Single Photon Emission Computed Tomography (SPECT)
Time frame: Week 4
1 secondary outcome
Change From Baseline in alcohol intake
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
Related trials for Alcohol Dependence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Addolorato principal investigator
Department of Internal Medicine, Catholic University of Rome, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Alcohol Dependence, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Dopamine Transporter availability in the striatum throgh Single Photon Emission Computed Tomography (SPECT) (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.