Alcohol Use DisorderNCT03981185
aTBS for Treatment of Depression in AUD
A study testing Accelerated theta burst treatment in people with Alcohol Use Disorder and Depression, run by Stanford University.
Trial summary
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for improvement of depressive symptoms and drinking behavior in individuals with alcohol dependence. In this open label study, all participants will receive accelerated theta-burst stimulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder, Depression
- What is being tested?
- Accelerated theta burst treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 11 Jul 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Participant aged 18-65 years old with diagnosis of alcohol use disorder.
- Participant may also choose to or not to take pharmacotherapy during the study period.
- Participant has tried at least one medication in the past that has not helped the alcohol use disorder. If participants are taking medication, they must be on stable psychotropic medication or psychotherapy for at least 6 weeks prior to the study with plans to continue throughout study enrollment.
- Participant needs to be at least one week after last alcohol/ substance use and had the last drink within one year of the beginning of the study participation.
- Participant endorses depressive symptom(s), indicated by a MARDS score >= 20.
- All participants must be assigned to a psychiatrist and agree to continue to be assigned to a psychiatrist throughout study enrollment.
- Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.
About this study
Official title: Accelerated Theta Burst Stimulation for Treatment of Depression in Individuals With Detoxed Alcohol Use Disorder
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for improvement of depressive symptoms and drinking behavior in individuals with alcohol dependence. In this open label study, all participants will receive accelerated theta-burst stimulation.
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive procedure and an established technology. Research utilizing rTMS in patients with alcohol use disorder has shown some promising results. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters, such as using accelerated intermittent theta-burst stimulation (aiTBS), to reduce treatment times with possible enhanced efficacy with some preliminary success. This study intends to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.
- Conditions
- Alcohol Use Disorder, Depression
- Being tested
- Accelerated theta burst treatment
- Keywords
- depression, TMS, transcranial magnetic stimulation, theta burst, alcohol use disorder, alcohol addiction
- Medical subject headings
- Alcoholism, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated theta burst treatmentDevice
All participants will receive iTBS (intermittent theta burst stimulation) to the left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 80% of resting motor threshold adjust to the skull to cortical surface distance.
Stimulation will be delivered to L-DLPFC using the MagPRo stimulator.
| Study group | Role | What they receive |
|---|---|---|
| Accelerated theta burst treatment | Experimental | All participants will receive theta-burst TMS. Receives: Device: Accelerated theta burst treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.
The MADRS uses a 0 to 6 severity scale, scored following the interview. Scoring/Interpretation: Higher scores indicate increasing depressive symptoms. ... Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Measured: Baseline and immediate post-stimulation
Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.
The MADRS uses a 0 to 6 severity scale, scored following the interview. Scoring/Interpretation: Higher scores indicate increasing depressive symptoms. ... Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Measured: Baseline and 1 month post-stimulation
Secondary outcomes (5)
Change in functional connectivity from baseline as measured by MR imaging
Pre- and post resting state functional connectivity and structural T1-weighted MRI scans to determine the anti-correlated LDLPFC and SCC treatment location. The identified cluster with the greatest anti-correlation between the LDLPFC and SCC will have been utilized for the targeted aiTBS treatment. This algorithm will have also been applied to the post-imaging sessions to give measurements of voxel-wise blood flow in this anti-correlation targeted brain ROI.
Measured: Baseline and immediate post-stimulation
Change in functional connectivity from baseline as measured by MR imaging
Pre- and post resting state functional connectivity and structural T1-weighted MRI scans to determine the anti-correlated LDLPFC and SCC treatment location. The identified cluster with the greatest anti-correlation between the LDLPFC and SCC will have been utilized for the targeted aiTBS treatment. This algorithm will have also been applied to the post-imaging sessions to give measurements of voxel-wise blood flow in this anti-correlation targeted brain ROI.
Measured: Baseline and 1 month post-stimulation
Change in alcohol craving and consumption measured by Obsessive Compulsive Drinking Scale (OCDS)
OCDS is a 14-question self-rate tool to measure obsessive thoughts about alcohol and compulsive use of alcohol. The minimum obtainable score is 0, while the maximum obtainable score is 56. Higher scores represent a worse outcome.
Measured: Baseline and immediate post-stimulation
Change in alcohol craving and consumption measured by Obsessive Compulsive Drinking Scale (OCDS)
OCDS is a 14-question self-rate tool to measure obsessive thoughts about alcohol and compulsive use of alcohol. The minimum obtainable score is 0, while the maximum obtainable score is 56. Higher scores represent a worse outcome.
Measured: Baseline and 1 month post-stimulation
Change in heart rate variability
Heart rate variability will be measured using a NeuroConn device which involves electrodes being placed on the chest to record heart rate.
Measured: At the beginning and end of each stimulation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start1 Jan 2024
- Primary completion11 Jul 2024
- Study completion11 Jul 2024
Why it stopped: No participants enrolled. No longer continuing with study.
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.
- More trials run by Stanford UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Sahlem, Stanford University
- Investigators
- Nolan Williams, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981185
- Sponsor's protocol ID
- 47388
- Status last verified
- Jul 2024
- First submitted
- 12 Jan 2019
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Theta Burst Stimulation for Treatment of Depression in Individuals With Detoxed Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT03981185
- Acronym / sponsor ID
- 47388
- Conditions
- Alcohol Use Disorder, Depression
- Keywords
- depression, TMS, transcranial magnetic stimulation, theta burst, alcohol use disorder, alcohol addiction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled. No longer continuing with study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 10 Jun 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 study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for improvement of depressive symptoms and drinking behavior in individuals with alcohol dependence. In this open label study, all participants will receive accelerated theta-burst stimulation.
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive procedure and an established technology. Research utilizing rTMS in patients with alcohol use disorder has shown some promising results. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters, such as using accelerated intermittent theta-burst stimulation (aiTBS), to reduce treatment times with possible enhanced efficacy with some preliminary success. This study intends to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accelerated theta burst treatment | Experimental | Device: Accelerated theta burst treatmentAll participants will receive theta-burst TMS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Accelerated theta burst treatmentAll participants will receive iTBS (intermittent theta burst stimulation) to the left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 80% of resting motor threshold adjust to the skull to cortical surface distance. Stimulation will be delivered to L-DLPFC using the MagPRo stimulator. | Device | Accelerated theta burst treatment |
Primary outcome
Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: Baseline and immediate post-stimulation
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS uses a 0 to 6 severity scale, scored following the interview. Scoring/Interpretation: Higher scores indicate increasing depressive symptoms. ... Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: Baseline and 1 month post-stimulation
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS uses a 0 to 6 severity scale, scored following the interview. Scoring/Interpretation: Higher scores indicate increasing depressive symptoms. ... Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
5 secondary outcomes
Change in functional connectivity from baseline as measured by MR imaging
Time frame: Baseline and immediate post-stimulation
Change in functional connectivity from baseline as measured by MR imaging
Time frame: Baseline and 1 month post-stimulation
Change in alcohol craving and consumption measured by Obsessive Compulsive Drinking Scale (OCDS)
Time frame: Baseline and immediate post-stimulation
Change in alcohol craving and consumption measured by Obsessive Compulsive Drinking Scale (OCDS)
Time frame: Baseline and 1 month post-stimulation
Change in heart rate variability
Time frame: At the beginning and end of each stimulation day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- 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.
Nolan Williams, MD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated theta burst treatment in people with Alcohol Use Disorder and Depression, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.
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 from baseline Montgomery Asberg Depression Rating Scale (MADRS) (time frame: Baseline and immediate post-stimulation). 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 16 Jul 2024.