AlcoholismNCT03969251
Transcranial Magnetic Stimulation (TMS) Treatment for Alcohol Use Disorder
A study testing Transcranial Magnetic Stimulation (rTMS) in people with Alcoholism, run by Nassima Ait-Daoud Tiouririne at 1 site in United States.
Trial summary
This is a pilot study designed to evaluate the efficacy of High Frequency (HF) repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (L-DLPFC) at improving cognitive flexibility in recently detoxified individuals with alcohol use disorder (AUD) compared to placebo (Sham rTMS). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Alcoholism
- What is being tested?
- Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2019to 10 Feb 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Right handed males and females who have given written informed consent.
- Age 22 years and above with a history of alcohol use disorder
- Good physical health
- Have a current diagnosis of alcohol use disorder
- Reports at least 4 "heavy drinking days" on average in the past 30 days.
- Have a BAC by breathalyzer equal to 0.000 when the participants signed the informed consent document
Show all 9Show fewer
- Six months stability on any psychotropic medications
- Not have any unresolved legal problems that could jeopardize continuation or completion of the study.
- Be able to provide written informed consent, able to understand written and oral instructions in English and be able to complete the questionnaires required by the protocol.
Who cannot join
- Please contact site for additional information.
Trial locations and contacts
1 site in 1 country.
United States1 site
UVA Center for Leading Edge Addiction Research
Charlottesville, Virginia, 22903
About this study
Official title: Optimizing Treatment for Alcohol Use Disorder (AUD) Using Targeted Transcranial Magnetic Stimulation
This is a pilot study designed to evaluate the efficacy of High Frequency (HF) repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (L-DLPFC) at improving cognitive flexibility in recently detoxified individuals with alcohol use disorder (AUD) compared to placebo (Sham rTMS). The total number of subjects requested to be randomized is 20. The investigator will need to screen about 40 subjects to have 20 subjects started on rTMS session at a ratio of 2 screens/1 subject randomized.
Read the detailed description
This is a randomized double- blind, control study.
To test the hypothesis, the investigator propose a 2 phase design:
Phase 1: 6-week trial comparing the efficacy of active high-frequency (HF) rTMS of L-DLPFC versus sham (SS) rTMS to determine if HF rTMS improves cognitive flexibility in recently detoxified alcoholics Phase 2: at the end of TMS phase, all participants will receive cognitive behavioral therapy (CBT) thus permitting participants with AUD to benefit from cognitive restructuring in CBT, and reduce alcohol cravings and drinking outcomes.
This study will recruit 20 individuals with AUD, comprising of both male and female participants, age 22 years and older interested in alcohol drinking abstinence. Participants will be recruited from the inpatient unit upon discharge after receiving a detoxification treatment and therefore will be abstinent at study entry. Prior to treatment onset and weekly throughout the course of treatment, participants will complete cognitive testing/measures, Wisconsin Card Sorting Task (WCST), Dimensional Change Card Sort Task (DCCST), Barratt Impulsiveness Scale (BIS), Flanker Inhibitory Control and Attention Test (FICAT), and List Sorting Working Memory Test (LSWMT) and self-reported craving measures, Alcohol Craving Questionnaire (ACQ-Now), and Obsessive Compulsive Drinking Scale (OCDS). The drinking timeline follow-back, and adverse events will also be assessed weekly for 8 weeks.
Participant will be randomized to either high frequency (HF) or sham repetitive transcranial magnetic stimulation (SS rTMS), which will be done 5 days per week for 6 weeks. At the end of 6 weeks, all participants will receive weekly CBT for a total of 8 weeks. Participants will return at 2 and 4 weeks for follow-up assessments.
- Conditions
- Alcoholism
- Being tested
- Transcranial Magnetic Stimulation (rTMS), Sham (SS)
- Keywords
- alcohol, alcohol dependence, addiction, alcohol use disorder
- Medical subject headings
- Alcoholism, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (rTMS)Device
active high frequency repetitive TMS of left Dorsolateral Prefrontal Cortex
Sham (SS)Device
repetitive sham rTMS
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Magnetic Stimulation (rTMS) | Experimental | repetitive transcranial magnetic stimulation Receives: Device: Transcranial Magnetic Stimulation (rTMS) |
| Sham (SS) | Sham comparator | repetitive sham rTMS Receives: Device: Sham (SS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wisconsin Card Sorting Test (WCST)
This is a neuropsychological task that measures flexibility in thinking, or "set shifting," during changing reinforcement schedules.
Measured: Up to 5 months
Dimensional Change Card Sort Task (DCCST)
This is a neuropsychological task that measures cognitive flexibility and attention.
Measured: Up to 5 months
Flanker Inhibitory Control and Attention Test (FICAT)
This is a neuropsychological task that measures attention and inhibitory control.
Measured: Up to 5 months
List Sorting Working Memory Test (LSWMT)
This is a neuropsychological task that measures working memory.
Measured: Up to 5 months
Secondary outcomes (4)
Drinks Per Drinking Day
The investigator will use timeline follow-back to capture this drinking outcome.
Measured: Up to 5 months
Percentage of Days of Abstinence
The investigator will use timeline follow-back to capture this drinking outcome.
Measured: Up to 5 months
Percentage of Heavy Drinking Days
The investigator will use timeline follow-back to capture this drinking outcome.
Measured: Up to 5 months
Alcohol Craving Questionnaire (ACQ-NOW)
This is a 47-item self-administered, multidimensional state measure of acute alcohol craving adapted from the Cocaine Craving Questionnaire. It measures the subscales of alcohol craving labeled Emotionality, Purposefulness, Compulsivity, and Expectancy.
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start11 Jul 2019
- Primary completion10 Feb 2021
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies 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
- Nassima Ait-Daoud Tiouririne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nassima Ait-Daoud Tiouririne, University of Virginia
- Investigators
- Nassima Ait-Daoud TIouririne, M.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969251
- Sponsor's protocol ID
- 21193
- Status last verified
- May 2026
- First submitted
- 27 Mar 2019
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Treatment for Alcohol Use Disorder (AUD) Using Targeted Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT03969251
- Acronym / sponsor ID
- 21193
- Conditions
- Alcoholism
- Keywords
- alcohol, alcohol dependence, addiction, alcohol use disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Nassima Ait-Daoud TiouririneUniversity, hospital or other
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 31 May 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.
This is a pilot study designed to evaluate the efficacy of High Frequency (HF) repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (L-DLPFC) at improving cognitive flexibility in recently detoxified individuals with alcohol use disorder (AUD) compared to placebo (Sham rTMS). The total number of subjects requested to be randomized is 20. The investigator will need to screen about 40 subjects to have 20 subjects started on rTMS session at a ratio of 2 screens/1 subject randomized.
Detailed description
This is a randomized double- blind, control study.
To test the hypothesis, the investigator propose a 2 phase design:
Phase 1: 6-week trial comparing the efficacy of active high-frequency (HF) rTMS of L-DLPFC versus sham (SS) rTMS to determine if HF rTMS improves cognitive flexibility in recently detoxified alcoholics Phase 2: at the end of TMS phase, all participants will receive cognitive behavioral therapy (CBT) thus permitting participants with AUD to benefit from cognitive restructuring in CBT, and reduce alcohol cravings and drinking outcomes.
This study will recruit 20 individuals with AUD, comprising of both male and female participants, age 22 years and older interested in alcohol drinking abstinence. Participants will be recruited from the inpatient unit upon discharge after receiving a detoxification treatment and therefore will be abstinent at study entry. Prior to treatment onset and weekly throughout the course of treatment, participants will complete cognitive testing/measures, Wisconsin Card Sorting Task (WCST), Dimensional Change Card Sort Task (DCCST), Barratt Impulsiveness Scale (BIS), Flanker Inhibitory Control and Attention Test (FICAT), and List Sorting Working Memory Test (LSWMT) and self-reported craving measures, Alcohol Craving Questionnaire (ACQ-Now), and Obsessive Compulsive Drinking Scale (OCDS). The drinking timeline follow-back, and adverse events will also be assessed weekly for 8 weeks.
Participant will be randomized to either high frequency (HF) or sham repetitive transcranial magnetic stimulation (SS rTMS), which will be done 5 days per week for 6 weeks. At the end of 6 weeks, all participants will receive weekly CBT for a total of 8 weeks. Participants will return at 2 and 4 weeks for follow-up assessments.
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 |
|---|---|---|
| Transcranial Magnetic Stimulation (rTMS) | Experimental | Device: Transcranial Magnetic Stimulation (rTMS)repetitive transcranial magnetic stimulation |
| Sham (SS) | Sham comparator | Device: Sham (SS)repetitive sham rTMS |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Right handed males and females who have given written informed consent.
- Age 22 years and above with a history of alcohol use disorder
- Good physical health
- Have a current diagnosis of alcohol use disorder
- Reports at least 4 "heavy drinking days" on average in the past 30 days.
Key exclusion criteria (1 listed)
- Please contact site for additional information.
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 |
|---|---|---|
| Transcranial Magnetic Stimulation (rTMS)active high frequency repetitive TMS of left Dorsolateral Prefrontal Cortex | Device | Transcranial Magnetic Stimulation (rTMS) |
| Sham (SS)repetitive sham rTMS | Device | Sham (SS) |
Primary outcome
Wisconsin Card Sorting Test (WCST)
Time frame: Up to 5 months
This is a neuropsychological task that measures flexibility in thinking, or "set shifting," during changing reinforcement schedules.
Dimensional Change Card Sort Task (DCCST)
Time frame: Up to 5 months
This is a neuropsychological task that measures cognitive flexibility and attention.
Flanker Inhibitory Control and Attention Test (FICAT)
Time frame: Up to 5 months
This is a neuropsychological task that measures attention and inhibitory control.
List Sorting Working Memory Test (LSWMT)
Time frame: Up to 5 months
This is a neuropsychological task that measures working memory.
4 secondary outcomes
Drinks Per Drinking Day
Time frame: Up to 5 months
Percentage of Days of Abstinence
Time frame: Up to 5 months
Percentage of Heavy Drinking Days
Time frame: Up to 5 months
Alcohol Craving Questionnaire (ACQ-NOW)
Time frame: Up to 5 months
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 27 May 2026.
- Individual participant dataSharing planned: No
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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.
Nassima Ait-Daoud TIouririne, M.D. principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (rTMS) in people with Alcoholism, run by Nassima Ait-Daoud Tiouririne 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 9 inclusion and 1 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 27 May 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?
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?
Wisconsin Card Sorting Test (WCST) (time frame: Up to 5 months). The study lists 4 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 27 May 2026.