Gambling DisorderNCT07923032
Low-Intensity Focused Ultrasound for Gambling Disorder
A study testing Active Low-Intensity Focused Ultrasound (LIFU) in people with Gambling Disorder and Gambling Addiction, run by University of Virginia at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether low-intensity focused ultrasound (LIFU) is safe and may help reduce gambling-related symptoms in adults seeking treatment for gambling disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gambling Disorder, Gambling Addiction, Gambling Problem
- What is being tested?
- Active Low-Intensity Focused Ultrasound (LIFU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2027to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults 18 to 60 years old.
- Currently diagnosed with gambling disorder, confirmed by a clinical interview.
- Seeking treatment for gambling disorder, including people currently participating in or transitioning from addiction treatment programs.
- In generally good enough physical health to safely participate in study procedures.
- Not pregnant and not planning to become pregnant during study participation.
- Able to speak and read English well enough to provide informed consent and complete study assessments.
- Able to safely undergo MRI scans (for example, no metal implants or other conditions that would make MRI unsafe).
- Willing to be randomly assigned to either study group, attend all study visits, and participate in weekly telehealth counseling sessions.
Who cannot join
- Significant heart, lung, liver, kidney, blood vessel, or blood-clotting problems that may make participation unsafe.
- Unwilling to avoid illegal substance use on study procedure days.
- Currently participating in court-ordered treatment.
- Skin or scalp conditions over the treatment area that may interfere with the study procedure.
- A medical condition that the study doctor believes could increase the risks of the ultrasound procedure, such as a history of seizures, stroke, serious brain injury, or certain brain abnormalities.
- Current or past schizophrenia, another psychotic disorder, or bipolar disorder.
Show all 10Show fewer
- Diagnosis of a Cluster A or Cluster B personality disorder.
- Unable to safely undergo an MRI scan.
- Pregnant or planning to become pregnant during the study.
- Previous treatment with focused ultrasound neuromodulation or another investigational neuromodulation treatment within the past 90 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
James Mahoney, PhD, 434-924-2097, jamesmahoney@virginia.edu
Daisy Thompson-Lake, PhD, 434-924-2097, daisythompsonlake@virginia.edu
About this study
Official title: A Randomized, Sham-Controlled Trial of Low Intensity Focused Ultrasound Neuromodulation as an Adjunctive Treatment for Gambling Disorder
The goal of this clinical trial is to learn whether low-intensity focused ultrasound (LIFU) is safe and may help reduce gambling-related symptoms in adults seeking treatment for gambling disorder.
The main questions it aims to answer are:
Read more
- Is LIFU safe and well tolerated in adults with gambling disorder?
- Does LIFU reduce gambling behavior compared with a sham (inactive) procedure?
Researchers will compare participants who receive active LIFU with participants who receive sham LIFU to see whether active treatment leads to greater reductions in gambling behavior.
Participants will:
- Be randomly assigned to receive either active LIFU or sham LIFU.
- Receive nine treatment sessions delivered over three treatment days within a five-day period.
- Participate in weekly telehealth cognitive behavioral therapy (CBT).
- Complete assessments of gambling behavior, gambling urges, mood, and quality of life.
- Attend follow-up visits for up to 90 days after active LIFU treatment.
Low-intensity focused ultrasound is a noninvasive technique that uses focused sound waves to influence brain activity. Researchers believe this approach may affect brain circuits involved in reward, cravings, and decision-making that contribute to gambling disorder.
- Conditions
- Gambling Disorder, Gambling Addiction, Gambling Problem, Gambling
- Being tested
- Active Low-Intensity Focused Ultrasound (LIFU), Sham Low-Intensity Focused Ultrasound (LIFU)
- Keywords
- low intensity focused ultrasound, LIFU, focused ultrasound, ultrasound
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Low-Intensity Focused Ultrasound (LIFU)Device
Active low-intensity focused ultrasound (LIFU) neuromodulation targeting the left and right nucleus accumbens. Each treatment course comprises three 10-minute sessions per day (5 minutes to the left nucleus accumbens and 5 minutes to the right nucleus accumbens) delivered on three treatment days within a 5-day window, for a total of nine sessions. Participants also receive standard-of-care, once-weekly telehealth cognitive behavioral therapy (CBT).
Sham Low-Intensity Focused Ultrasound (LIFU)Device
Sham low-intensity focused ultrasound procedures that are identical to active treatment except that no therapeutic ultrasound energy is delivered. Each treatment course comprises three 10-minute sessions per day on three treatment days within a 5-day window, for a total of nine sessions. Participants also receive standard-of-care, once-weekly telehealth cognitive behavioral therapy (CBT). After completion of the Day 30 primary endpoint assessments and unblinding, participants may cross over to receive open-label active LIFU.
| Study group | Role | What they receive |
|---|---|---|
| Active LIFU Treatment | Experimental | Device: Low Intensity Focused Ultrasound
* Each course comprises of three 10-minute sessions of Active LIFU per day (5 minutes to the left NAc, then 5 minutes to the right) on three treatment days scheduled within a 5-day window (i.e., nine sessions per course).
* During the randomized phase (through post-LIFU Day 30), the trial operates as a parallel-group comparison of active LIFU versus sham, with both arms receiving standard-of-care, once-weekly telehealth CBT. Receives: Device: Active Low-Intensity Focused Ultrasound (LIFU) |
| Sham LIFU Treatment | Sham comparator | Device: Low Intensity Focused Ultrasound
* Each course comprises of three 10-minute sessions of Sham LIFU per day (5 minutes to the left NAc, then 5 minutes to the right) on three treatment days scheduled within a 5-day window (i.e., nine sessions per course).
* Sham session is procedurally identical to Active LIFU session with the exception that no energy is delivered during the procedures.
* During the randomized phase (through post-LIFU Day 30), the trial operates as a parallel-group comparison of active LIFU versus sham, with both arms receiving standard-of-care once-weekly telehealth CBT.
* After the Day 30 primary endpoint and unblinding, the sham arm crosses over to open-label active LIFU and repeats the identical treatment and assessment sequence, so every participant ultimately receives active treatment. Receives: Device: Sham Low-Intensity Focused Ultrasound (LIFU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Device-Related and Procedure-Related Adverse Events
Number of participants who experience at least one device-related or investigational procedure-related adverse event (AE) or serious adverse event (SAE) during the randomized treatment phase. Adverse event severity and relationship to study procedures will be assessed by the study investigator.
Measured: Randomization through Day 30
Change From Baseline in Gambling Frequency Measured by the Gambling Timeline Follow-Back (G-TLFB)
The G-TLFB is a calendar-based self-report assessment that uses memory cues and a timeline method to estimate gambling activity over a specified period. Gambling frequency is assessed by retrospectively recording gambling behavior during the assessment period. Higher values indicate greater gambling frequency.
Measured: Baseline to Day 30
Secondary outcomes (8)
Change From Baseline in Time Spent Gambling Measured by the Gambling Timeline Follow-Back (G-TLFB)
The G-TLFB is a calendar-based self-report assessment that retrospectively records gambling behavior over a specified period. The outcome is the total time spent gambling during the assessment period. Higher values indicate greater time spent gambling.
Measured: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Amount of Money Gambled Measured by the Gambling Timeline Follow-Back (G-TLFB)
The G-TLFB is a calendar-based self-report assessment that retrospectively records gambling behavior over a specified period. The outcome is the total amount of money gambled during the assessment period. Higher values indicate greater gambling expenditure.
Measured: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Desire to Gamble During a Cue Reactivity Task
Participants will view gambling-related cues and rate their desire to gamble using a visual analog scale ranging from 0 to 100, where 0 indicates no desire to gamble and 100 indicates the strongest desire possible. Higher scores indicate greater desire to gamble.
Measured: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Gambling Symptom Severity Measured by the Gambling Symptom Assessment Scale (GSAS)
The Gambling Symptom Assessment Scale GSAS is a 12-item self-report measure of gambling urges, thoughts, and behaviors during the previous week. Total scores range from 0 to 48, with higher scores indicating greater gambling symptom severity.
Measured: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Gambling Symptom Severity Measured by the Pathological Gambling Yale-Brown Obsessive Compulsive Scale (PG-YBOCS)
The Pathological Gambling Yale-Brown Obsessive Compulsive Scale (PG-YBOCS) is a clinician-administered measure of gambling-related thoughts, urges, and behaviors. Total scores range from 0 to 40, with higher scores indicating greater gambling symptom severity.
Measured: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Depression Symptom Severity Measured by the Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report measure of depressive symptoms. Total scores range from 0 to 27, with higher scores indicating greater depression symptom severity.
Measured: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Anxiety Symptom Severity Measured by the Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report measure of anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Measured: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Quality of Life Measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF)
The World Health Organization Quality of Life-BREF (WHOQOL-BREF) is a 26-item self-report measure that assesses physical, psychological, social, and environmental domains of quality of life. Higher scores indicate better quality of life.
Measured: Baseline through Day 90 post-active LIFU treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startFeb 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gambling DisorderStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Randomization will occur after all inclusion criteria have been met at which time participants will be randomized 1:1 to either the Active or the Sham arm. After a participant completes the Day 30 post-LIFU study visit, that participant's treatment assignment is unblinded. Participants randomized to the Sham arm will be crossed over and receive Active LIFU after specified baseline procedures/assessments
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- NaviFUS Corporation
- Responsible party
- Principal investigator, Daisy Thompson-Lake, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923032
- Sponsor's protocol ID
- 304205
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sham-Controlled Trial of Low Intensity Focused Ultrasound Neuromodulation as an Adjunctive Treatment for Gambling Disorder
- ClinicalTrials.gov ID
- NCT07923032
- Acronym / sponsor ID
- 304205
- Conditions
- Gambling Disorder, Gambling Addiction, Gambling Problem, Gambling
- Keywords
- low intensity focused ultrasound, LIFU, focused ultrasound, ultrasound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- NaviFUS Corporation
- Study start
- Feb 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 6 Nov 2026 (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 clinical trial is to learn whether low-intensity focused ultrasound (LIFU) is safe and may help reduce gambling-related symptoms in adults seeking treatment for gambling disorder.
The main questions it aims to answer are:
- Is LIFU safe and well tolerated in adults with gambling disorder?
- Does LIFU reduce gambling behavior compared with a sham (inactive) procedure?
Researchers will compare participants who receive active LIFU with participants who receive sham LIFU to see whether active treatment leads to greater reductions in gambling behavior.
Participants will:
- Be randomly assigned to receive either active LIFU or sham LIFU.
- Receive nine treatment sessions delivered over three treatment days within a five-day period.
- Participate in weekly telehealth cognitive behavioral therapy (CBT).
- Complete assessments of gambling behavior, gambling urges, mood, and quality of life.
- Attend follow-up visits for up to 90 days after active LIFU treatment.
Low-intensity focused ultrasound is a noninvasive technique that uses focused sound waves to influence brain activity. Researchers believe this approach may affect brain circuits involved in reward, cravings, and decision-making that contribute to gambling disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization will occur after all inclusion criteria have been met at which time participants will be randomized 1:1 to either the Active or the Sham arm. After a participant completes the Day 30 post-LIFU study visit, that participant's treatment assignment is unblinded. Participants randomized to the Sham arm will be crossed over and receive Active LIFU after specified baseline procedures/assessments
| Arm | Type | Receives |
|---|---|---|
| Active LIFU Treatment | Experimental | Device: Active Low-Intensity Focused Ultrasound (LIFU)Device: Low Intensity Focused Ultrasound * Each course comprises of three 10-minute sessions of Active LIFU per day (5 minutes to the left NAc, then 5 minutes to the right) on three treatment days scheduled within a 5-day window (i.e., nine sessions per course). * During the randomized phase (through post-LIFU Day 30), the trial operates as a parallel-group comparison of active LIFU versus sham, with both arms receiving standard-of-care, once-weekly telehealth CBT. |
| Sham LIFU Treatment | Sham comparator | Device: Sham Low-Intensity Focused Ultrasound (LIFU)Device: Low Intensity Focused Ultrasound * Each course comprises of three 10-minute sessions of Sham LIFU per day (5 minutes to the left NAc, then 5 minutes to the right) on three treatment days scheduled within a 5-day window (i.e., nine sessions per course). * Sham session is procedurally identical to Active LIFU session with the exception that no energy is delivered during the procedures. * During the randomized phase (through post-LIFU Day 30), the trial operates as a parallel-group comparison of active LIFU versus sham, with both arms receiving standard-of-care once-weekly telehealth CBT. * After the Day 30 primary endpoint and unblinding, the sham arm crosses over to open-label active LIFU and repeats the identical treatment and assessment sequence, so every participant ultimately receives active treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adults 18 to 60 years old.
- Currently diagnosed with gambling disorder, confirmed by a clinical interview.
- Seeking treatment for gambling disorder, including people currently participating in or transitioning from addiction treatment programs.
- In generally good enough physical health to safely participate in study procedures.
- Not pregnant and not planning to become pregnant during study participation.
Key exclusion criteria (10 listed)
- Significant heart, lung, liver, kidney, blood vessel, or blood-clotting problems that may make participation unsafe.
- Unwilling to avoid illegal substance use on study procedure days.
- Currently participating in court-ordered treatment.
- Skin or scalp conditions over the treatment area that may interfere with the study procedure.
- A medical condition that the study doctor believes could increase the risks of the ultrasound procedure, such as a history of seizures, stroke, serious brain injury, or certain brain abnormalities.
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 Low-Intensity Focused Ultrasound (LIFU)Active low-intensity focused ultrasound (LIFU) neuromodulation targeting the left and right nucleus accumbens. Each treatment course comprises three 10-minute sessions per day (5 minutes to the left nucleus accumbens and 5 minutes to the right nucleus accumbens) delivered on three treatment days within a 5-day window, for a total of nine sessions. Participants also receive standard-of-care, once-weekly telehealth cognitive behavioral therapy (CBT). | Device | Active LIFU Treatment |
| Sham Low-Intensity Focused Ultrasound (LIFU)Sham low-intensity focused ultrasound procedures that are identical to active treatment except that no therapeutic ultrasound energy is delivered. Each treatment course comprises three 10-minute sessions per day on three treatment days within a 5-day window, for a total of nine sessions. Participants also receive standard-of-care, once-weekly telehealth cognitive behavioral therapy (CBT). After completion of the Day 30 primary endpoint assessments and unblinding, participants may cross over to receive open-label active LIFU. | Device | Sham LIFU Treatment |
Primary outcome
Incidence of Device-Related and Procedure-Related Adverse Events
Time frame: Randomization through Day 30
Number of participants who experience at least one device-related or investigational procedure-related adverse event (AE) or serious adverse event (SAE) during the randomized treatment phase. Adverse event severity and relationship to study procedures will be assessed by the study investigator.
Change From Baseline in Gambling Frequency Measured by the Gambling Timeline Follow-Back (G-TLFB)
Time frame: Baseline to Day 30
The G-TLFB is a calendar-based self-report assessment that uses memory cues and a timeline method to estimate gambling activity over a specified period. Gambling frequency is assessed by retrospectively recording gambling behavior during the assessment period. Higher values indicate greater gambling frequency.
8 secondary outcomes
Change From Baseline in Time Spent Gambling Measured by the Gambling Timeline Follow-Back (G-TLFB)
Time frame: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Amount of Money Gambled Measured by the Gambling Timeline Follow-Back (G-TLFB)
Time frame: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Desire to Gamble During a Cue Reactivity Task
Time frame: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Gambling Symptom Severity Measured by the Gambling Symptom Assessment Scale (GSAS)
Time frame: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Gambling Symptom Severity Measured by the Pathological Gambling Yale-Brown Obsessive Compulsive Scale (PG-YBOCS)
Time frame: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Depression Symptom Severity Measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Anxiety Symptom Severity Measured by the Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Quality of Life Measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time frame: Baseline through Day 90 post-active LIFU treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 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.
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 Low-Intensity Focused Ultrasound (LIFU) in people with Gambling Disorder and Gambling Addiction, run by University of Virginia 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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 6 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Device-Related and Procedure-Related Adverse Events (time frame: Randomization through Day 30). 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 6 Nov 2026.