ClinicalTrials.gg
Not yet recruitingNCT07930299Updated Nov 12, 2026

Neuromodulation of Executive Control for Substance Use Disorders

An interventional study of Electrical Stimulation and Sham intervention in Drug Use Disorder, sponsored by University of Texas Southwestern Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Prevention

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Substance-Related Disorders by University of Texas Southwestern Medical Center — 3 open to participants now, 3 under way, none of them phase 3. Substance-Related Disorders · University of Texas Southwestern Medical Center.

Started
2026
with 1 other
No phase
3 of 10
2 open now
Registered
10th of 10
by date

Among the 10 studies in Substance-Related Disorders by University of Texas Southwestern Medical Center, this one is one of 2 that started in 2026, is one of 3 with no phase, and was the 10th registered.

Substance-Related Disorders

2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.

Browse Substance-Related Disorders studies →

Open to participants now

3 of the 10 studies in Substance-Related Disorders by University of Texas Southwestern Medical Center are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 266 Substance-Related Disorders studies recruiting now, 130 (49%) set no upper age limit and 118 (44%) stop at 75 or younger; 56 take children under 18; 89 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Substance-Related Disorders by University of Texas Southwestern Medical Center, or all of them as a file.
02

Study summary

The purpose of this research study is to determine the effectiveness of a procedure called transcranial alternating current stimulation (tACS) using a device called StarStim cap and its effects on drug cravings.

Read the detailed description

Participants will undergo a 1-2-day screening that includes a urine drug screen, clinical interview, and self-reporting assessments, once screening is complete, participants will complete a (EEG) recording of your brainwaves. The EEG recording and electrode placement will take about 2 hours. The next portion of the study will involve the use of the StarStim device and an MRI, and you will be asked a series of questions while wearing the device. The day after the MRI scan you will receive a short phone call from study staff. You will be asked to participate in study visits for 2 or 3 days and have 1 follow-up visit. Total study duration for this research study is up to 2 weeks.

The electrical stimulation that the StarStim device uses is considered to be safe, and we are not anticipating any serious side effects. However, mild side effects could include headache, itching and tingling. There are additional risks involved with MRI scans.

You may not receive any personal benefits from being in this study. We hope the information learned from this study will benefit other people with similar conditions in the future.

If you are interested in learning more about this study, please continue to read below. Participating in this research study is voluntary; it is your choice.

03

Conditions studied

  • Drug Use Disorder

Keywords

  • MRI
  • Substance Use
  • Cognition
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Able to provide written consent and comply with study procedures.
  2. Adults aged 18 to 65 years at the time of consent.
  3. Meets the MINI diagnostic criteria for either methamphetamine use disorder (MUD).

Exclusion criteria

Exclusion Criteria:

  1. Any for tACS or MRI scanning (tACS contraindication: history of seizures; potential MRI contraindications, up to the discretion of AIRC and CBH staff: metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder).
  2. Any medical condition or treatment with neurological sequelae (i.e., stroke, tumor).
  3. Over 9 months of abstinence from substance use.
  4. A head injury resulting in a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI).
  5. Presence of a condition that would render study measures difficult or impossible to administer or interpret.
  6. Entrance to the treatment program under a court mandate. (i.e. legally incarcerated).
  7. History of ECT or cortical energy exposure within the past 6 months, including participation in any other neuromodulation studies.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Arm 1: Active intervention- tES (transcranial electrical stimulation), then Sham Intervention

    tES is considered to be a safe brain stimulation technique that rarely results in adverse events. There is currently no evidence of serious side-effects. Mild side-effects that typically resolve upon discontinuing tACS. The subject may choose to discontinue stimulation at any time during the session if experiencing excessive discomfort or side effects.

    Device: Electrical Stimulation · Device: Sham intervention

  • Experimental
    Arm 2: Sham intervention, then Active comparator intervention

    Device: Electrical Stimulation · Device: Sham intervention

Interventions

  • DeviceElectrical Stimulation

    This study involves the use of an investigational device called StarStim. "Investigational" means that the device has not yet been approved by the U.S. Food \& Drug Administration (FDA) for helping people recover from drug addiction. This study will help find out what effects, good and/or bad, this device has. The safety of this device in humans has been tested in prior research studies; however, some side effects may not yet be known

  • DeviceSham intervention

    comparator arm

06

What researchers measure

Primary outcomes

  1. Brain stimulation and MRI

    Task-dependent functional connectivity measured using psychophysiological interaction (PPI) analysis of blood oxygen level-dependent (BOLD) functional MRI data. PPI regression coefficients quantify differences in connectivity during drug-related versus neutral cues within the executive control network, including the dorsolateral prefrontal cortex and inferior parietal cortex, and between executive control regions and limbic regions, including the ventral striatum and amygdala. Connection-specific PPI coefficients will be reported separately, with within-participant comparisons between active in-phase, active anti-phase, and sham tACS conditions.

    Time frame: Individual participant data will be analyzed after completion of that participant's study procedures. The final study-level outcome analysis and reporting are planned by study completion, anticipated within one year. This analysis and reporting schedule

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Aug 2030, 45 months later.

Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's planned 45 months is above that.

Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2026
First posted
Nov 12, 2026
StartEst.
Oct 15, 2026
Primary completionEst.
Aug 1, 2030
CompletionEst.
Aug 1, 2030
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07930299
Responsible party
Hamed Ekhtiari (Associate Professor, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Nov 12, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Aug 1, 2030 (estimated)
Completion
Aug 1, 2030 (estimated)
Last update
Nov 12, 2026

Study contacts

Aref Pariz, PhD
Contact
Aref.Pariz@UTSouthwestern.edu
612-624-0134
Stephanie Neaves, MRC
Contact
214-648-86044

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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