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NCT03291431 · ClinicalTrials.gov registry record · NA
Intermittent Theta Burst for the Treatment of Alcohol Use Disorders in Veterans
A NA study, sponsored by Stanford University.
- Terminated
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT03291431: Clinical Trial NA study, sponsored by Stanford University.
NCT03291431 is a NA study that was terminated before completion, run by Stanford University. The registered enrollment target is 17 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03291431, a NA study, was terminated before completion, sponsored by Stanford University.
- TERMINATED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of intermittent theta burst repetitive transcranial magnetic stimulation (iTBS) as a treatment for Veterans with an alcohol use disorder (AUD) to decrease the exceedingly high rate of relapse associated with this condition. iTBS has demonstrated equivalent efficacy and safety to repetitive transcranial magnetic stimulation employing 10Hz stimulation protocols in treatment of depressive disorders. The advantage of iTBS is that it can be delivered in approximately 5 minutes where conventional 10Hz repetitive transcranial magnetic stimulation (rTMS) protocols are typically 20-25 minutes. It is hypothesized that Veterans with AUD who receive active iTBS applied to the left dorsolateral prefrontal cortex (DLPFC), compared to controls (i.e., Veterans with AUD who receive sham iTBS), will show significant decreases alcohol craving, depressive symptomatology and cigarette consumptions, as well as improved neurocognition, a longer period of abstinence, and a lower overall rate of relapse over 6 months following standard psychosocial treatment for AUD at VA substance treatment clinics. In exploratory analyses, it is also predicted that magnetic resonance measures of left DLPFC glutamate concentration, volume of anterior frontal cortical brain regions, and performance on fMRI tasks interrogating the function of the salience/reward circuits will serve as biomarkers of iTBS treatment response. The goal of this proposal is to implement treatment that effectively promotes sustained abstinence in Veterans with AUD, given long-term abstinence is related to optimal neurobiological, neuropsychological and psychosocial recovery and functioning.
Primary Outcome
Number of particiants in active vs. sham who maintained completed abstinence from alcohol/substance over 6 months post final rTMS session.
Interventions
- DEVICE Intermittent theta burst transcranial magnetic stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2017-12-01 |
| Est. Completion | 2022-07-30 |
| Phase | NA |
Why NCT03291431 stopped before completion
NCT03291431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Intermittent theta burst transcranial magnetic stimulation is the first listed.
NCT03291431 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03291431 about?
NCT03291431 is a clinical study titled "Intermittent Theta Burst for the Treatment of Alcohol Use Disorders in Veterans". The purpose of this study is to evaluate the efficacy of intermittent theta burst repetitive transcranial magnetic stimulation (iTBS) as a treatment for Veterans with an alcohol use disorder (AUD) to decrease the exceedingly high rate of relapse associated with this condition. iTBS has demonstrated ...
What is the current status of trial NCT03291431?
This trial is currently terminated. It is a NA study. The enrollment target is 17 participants. The study started on 2017-12-01. Estimated completion is 2022-07-30.
What interventions are being tested in trial NCT03291431?
The interventions under investigation include: Intermittent theta burst transcranial magnetic stimulation (DEVICE).
Who is sponsoring clinical trial NCT03291431?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03291431's enrollment target sits among peer trials
17 1871st of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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