Alcohol Use DisorderMAGNANCT03809286
The Effect of rTMS to the Prefrontal Cortex in Alcohol Use Disorder
A study testing active rTMS and Inpatient admission in people with Alcohol Use Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The goal of this study is to investigate a treatment approach for alcohol use disorder (AUD) using a novel form of brain stimulation called deep repetitive transcranial magnetic stimulation (rTMS). The investigators will be targeting frontal regions of the brain that are important for memory and decision making. Read more about this study
- Who is it for?
- Ages 22 to 55 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- active rTMS and Inpatient admission
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2019to 30 Dec 2026
- 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 22 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Current moderate to severe alcohol use disorder, per DSM-5
- Use of alcohol which parallels or exceeds the amount alcohol that will be administered in this study (1 drinking episode per week raising BAL to 0.03 g/dl - approximately 2 drinks within an hour).
- Age 22-55
- Able to give informed consent, and comply with study procedures
- Medically healthy, with the absence of current or past medical or neurological illnesses (including glaucoma, increased intracranial pressure, liver disease, cardiac disease, or seizure disorders)
Who cannot join
- Has a contraindication to MRI, such as magnetically reactive implants, which includes metal in head except in mouth (cochlear implant, implanted brain stimulators, aneurysm clips), cardiac pacemakers, implanted neurostimulators and medication pumps, and intracardiac lines.
- Substance use disorder with substances other than alcohol or nicotine. The current use of sedative-hypnotics or opiates will be exclusionary
- Meets DSM-5 criteria for other psychiatric illness, such as major depression, that would interfere with participation.
- History of seizures of any type
- A family history of epilepsy
- Taking psychotropic medication that would affect resting motor threshold (such as anticonvulsants) or increase risk of seizure (especially tricyclic antidepressants of neuroleptics)
Show all 11Show fewer
- Current suicide risk or a history of suicide attempt within the past 2 years
- Have unstable physical disorders, including those that are previously undiagnosed, untreated, inadequately treated, or active to an extent which might make participation hazardous. For example, hypertension (a resting blood pressure > 140/90), heart failure, a recent history of myocardial infarction, previous stroke, brain lesions, any history of seizures under any circumstances or low hemoglobin.
- Currently pregnant
- History of severe alcohol withdrawal requiring medical care, such as withdrawal seizures, delirium tremens, withdrawal necessitating medical detoxification.
- A desire to pursue standard treatment for AUD, such as a rehabilitation program or FDA approved medications for AUD
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
The goal of this study is to investigate a treatment approach for alcohol use disorder (AUD) using a novel form of brain stimulation called deep repetitive transcranial magnetic stimulation (rTMS). The investigators will be targeting frontal regions of the brain that are important for memory and decision making. These brain regions have been shown to be impaired in patients with AUD. Previous studies have mostly used rTMS to a different frontal brain region that is not as deep. These studies have shown that rTMS can reduce craving for alcohol, but there is a lack of research showing that rTMS impacts alcohol consumption.
Read the detailed description
This study aims to examine the effect of rTMS on alcohol drinking behavior in an observed laboratory setting. Participants with AUD will be recruited and admitted to the inpatient unit for the whole study. After a brief detoxification period, they will receive 3 weeks of rTMS while in the research unit. Before and after the 3 weeks of stimulation, participants will participate in a decision-making experiment where they can choose to have an alcoholic drink or the equivalent amount of money that the drink would cost (alcohol self-administration sessions). The investigators will examine their response to alcohol, as well as their performance on tasks that relate to impulsivity and memory. Participants will also undergo an MRI scan (with spectroscopy) before and after the stimulation period to look at changes in the medial prefrontal cortex of the brain. Participants will then meet with a study physician for 6 weeks after the study for assessments of alcohol use and medical management sessions.
- Conditions
- Alcohol Use Disorder
- Being tested
- active rTMS, Inpatient admission, sham rTMS
- Keywords
- rTMS, alcohol use disorder
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active rTMSDevice
rTMS delivers magnetic stimulation to the brain by using an electromagnet to generate a current that can penetrate the scalp and skull.
Inpatient admissionBehavioural
All subjects will be admitted to the hospital for a brief detoxification period followed by 3 weeks of abstinence.
sham rTMSDevice
The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil, and to produce activation of facial muscles similar to the effect of a real H coil, without stimulating the brain itself.
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Experimental | Participants will be receiving active rTMS. Receives: Device: active rTMS; Behavioral: Inpatient admission |
| Sham Stimulation | Sham comparator | Participants will be receiving sham stimulation with a smaller coil housed within the rTMS device. Receives: Behavioral: Inpatient admission; Device: sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the choice to self-administer alcohol in the laboratory as assessed by counting the number of drinks consumed in the 2-hour laboratory session.
Participants will participate in alcohol self-administration sessions in which they are presented with the choice of alcohol or money. The investigators will study the change in choices to choose alcohol during these sessions. There will be one session prior to rTMS and one after 3 weeks of rTMS.
Measured: 4 weeks
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0.
Adverse events will be assessed in recorded in accordance with CTCAE v4.0.
Measured: 10 weeks
Secondary outcomes (4)
Change in craving for alcohol measured using the Alcohol Urge Questionnaire (AUQ).
This AUQ (Bohn et al. 1995) is an 8-item self report questionnaire where participants rate a seven-point Likert scale with responses ranging from "strongly disagree" to "strongly agree", and a total score is derived from the sum of these items following reverse scoring of two items. A lower score is a better outcome which represents less desire to drink. Scores range from 8-56.
Measured: 4 weeks
Change in GABA in the mPFC and ACC as measured with magnetic resonance spectroscopy (MRS).
MRS is performed by using an MRI machine to study metabolites and neurotransmitters in the brain.
Measured: 4 weeks
Change in abstinence from alcohol following discharge assessed with the Time Line Follow Back Interview.
Measured: 10 weeks
Changes in cognitive control as measured by using the Frontal Assessment Battery (FAB).
The FAB is a brief tool that discriminates between frontal-temporal type cognitive issues from from Alzheimer's type memory issues. Higher scores are better and scores range from 0-18.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start24 Jun 2019
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Why it stopped: The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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
- Model description
- active vs. sham stimulation
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Jonathan Wai, New York State Psychiatric Institute
- Investigators
- Jonathan Wai, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809286
- Sponsor's protocol ID
- 7691
- Other IDs
- 1K23AA028295, 5R21AA026049
- Acronym
- MAGNA
- Status last verified
- Mar 2026
- First submitted
- 9 Jan 2019
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of rTMS to the Prefrontal Cortex in Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT03809286
- Acronym / sponsor ID
- MAGNA / 7691
- Conditions
- Alcohol Use Disorder
- Keywords
- rTMS, alcohol use disorder
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Jan 2019 (actual)
- 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.
The goal of this study is to investigate a treatment approach for alcohol use disorder (AUD) using a novel form of brain stimulation called deep repetitive transcranial magnetic stimulation (rTMS). The investigators will be targeting frontal regions of the brain that are important for memory and decision making. These brain regions have been shown to be impaired in patients with AUD. Previous studies have mostly used rTMS to a different frontal brain region that is not as deep. These studies have shown that rTMS can reduce craving for alcohol, but there is a lack of research showing that rTMS impacts alcohol consumption.
Detailed description
This study aims to examine the effect of rTMS on alcohol drinking behavior in an observed laboratory setting. Participants with AUD will be recruited and admitted to the inpatient unit for the whole study. After a brief detoxification period, they will receive 3 weeks of rTMS while in the research unit. Before and after the 3 weeks of stimulation, participants will participate in a decision-making experiment where they can choose to have an alcoholic drink or the equivalent amount of money that the drink would cost (alcohol self-administration sessions). The investigators will examine their response to alcohol, as well as their performance on tasks that relate to impulsivity and memory. Participants will also undergo an MRI scan (with spectroscopy) before and after the stimulation period to look at changes in the medial prefrontal cortex of the brain. Participants will then meet with a study physician for 6 weeks after the study for assessments of alcohol use and medical management sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- active vs. sham stimulation
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Experimental | Device: active rTMS, Behavioral: Inpatient admissionParticipants will be receiving active rTMS. |
| Sham Stimulation | Sham comparator | Behavioral: Inpatient admission, Device: sham rTMSParticipants will be receiving sham stimulation with a smaller coil housed within the rTMS device. |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Current moderate to severe alcohol use disorder, per DSM-5
- Use of alcohol which parallels or exceeds the amount alcohol that will be administered in this study (1 drinking episode per week raising BAL to 0.03 g/dl - approximately 2 drinks within an hour).
- Age 22-55
- Able to give informed consent, and comply with study procedures
- Medically healthy, with the absence of current or past medical or neurological illnesses (including glaucoma, increased intracranial pressure, liver disease, cardiac disease, or seizure disorders)
Key exclusion criteria (11 listed)
- Has a contraindication to MRI, such as magnetically reactive implants, which includes metal in head except in mouth (cochlear implant, implanted brain stimulators, aneurysm clips), cardiac pacemakers, implanted neurostimulators and medication pumps, and intracardiac lines.
- Substance use disorder with substances other than alcohol or nicotine. The current use of sedative-hypnotics or opiates will be exclusionary
- Meets DSM-5 criteria for other psychiatric illness, such as major depression, that would interfere with participation.
- History of seizures of any type
- A family history of epilepsy
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 |
|---|---|---|
| active rTMSrTMS delivers magnetic stimulation to the brain by using an electromagnet to generate a current that can penetrate the scalp and skull. | Device | Active Stimulation |
| Inpatient admissionAll subjects will be admitted to the hospital for a brief detoxification period followed by 3 weeks of abstinence. | Behavioural | Active Stimulation, Sham Stimulation |
| sham rTMSThe sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil, and to produce activation of facial muscles similar to the effect of a real H coil, without stimulating the brain itself. | Device | Sham Stimulation |
Primary outcome
Change in the choice to self-administer alcohol in the laboratory as assessed by counting the number of drinks consumed in the 2-hour laboratory session.
Time frame: 4 weeks
Participants will participate in alcohol self-administration sessions in which they are presented with the choice of alcohol or money. The investigators will study the change in choices to choose alcohol during these sessions. There will be one session prior to rTMS and one after 3 weeks of rTMS.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0.
Time frame: 10 weeks
Adverse events will be assessed in recorded in accordance with CTCAE v4.0.
4 secondary outcomes
Change in craving for alcohol measured using the Alcohol Urge Questionnaire (AUQ).
Time frame: 4 weeks
Change in GABA in the mPFC and ACC as measured with magnetic resonance spectroscopy (MRS).
Time frame: 4 weeks
Change in abstinence from alcohol following discharge assessed with the Time Line Follow Back Interview.
Time frame: 10 weeks
Changes in cognitive control as measured by using the Frontal Assessment Battery (FAB).
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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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.
Jonathan Wai principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active rTMS and Inpatient admission in people with Alcohol Use Disorder, run by New York State Psychiatric Institute at 1 site in United States.
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 11 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: paused, as of the sponsor's last update on 19 Mar 2026. 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 United States. 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?
Results are not available in the source record.
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 in the choice to self-administer alcohol in the laboratory as assessed by counting the number of drinks consumed in the 2-hour laboratory session. (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 19 Mar 2026.