Alcohol Use DisorderNCT03291431
Intermittent Theta Burst for the Treatment of Alcohol Use Disorders in Veterans
A study testing Intermittent theta burst transcranial magnetic stimulation in people with Alcohol Use Disorder and Depressive Disorder, run by Stanford University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Use Disorder, Depressive Disorder, Cigarette Smoking
- What is being tested?
- Intermittent theta burst transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2017to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21-65 years of age
- Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for alcohol use disorder, and alcohol is self-identified as primary substance of misuse.
- Actively in treatment at VA Palo Alto HCS Addiction Treatment Service
- Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participation in study procedures.
Who cannot join
- History of Schizophrenia Spectrum Disorders, Bipolar Disorders, a
- Current substance use disorder that exceeds the severity of the AUD (based on DSM-5 diagnostic criteria)
- Current use of an FDA approved medication (i.e., disulfiram, acamprosate, and naltrexone) for treatment of AUD,
- Active current suicidal intent or plan (patients with a previous clinical flag for risk for suicide will be required to have an established safety plan involving their primary psychiatrist and the treatment team before entering the clinical trial),
- Any form of previous TMS or electroconvulsive treatment.
- Thyroid disease,
Show all 20Show fewer
- Unstable congestive heart failure, angina, other severe cardiac illness as defined by treatment regimen changes in the prior 3 months
- Cerebrovascular accident
- Cancer if < 1 year since end of treatment
- Unstable diabetes
- COPD requiring oxygen supplementation
- Alzheimer's disease
- Parkinson's disease
- Any Biomedical implants with ferromagnetic content
- Neurostimulation devices, cardiac pacemakers or any magnetic resonance contraindications
- Traumatic brain injury with self-reported or observed loss of consciousness > 30 minutes
- Any primary or traumatically induced seizure disorder
- Lack of fluency in English, Wechsler Adult Reading Test below the 7th percentile (i.e., moderate or greater impairment in estimated general intelligence),
- Females who are pregnant or actively attempting pregnancy (conservative exclusion for magnetic resonance research),
- Current use of any medication or substance that is documented to lower seizure threshold or has been identified as a contraindication for TMS treatment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Palo Alto VA Health Care System
Palo Alto, California, 94304
Stanford University
Stanford, California, 94305
About this study
Official title: Intermittent Theta Burst TMS 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 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.
- Conditions
- Alcohol Use Disorder, Depressive Disorder, Cigarette Smoking
- Being tested
- Intermittent theta burst transcranial magnetic stimulation
- Keywords
- alcohol use disorder, intermittent theta burst, Veterans, depressive disorder, cigarette smoking
- Medical subject headings
- Alcoholism, Depressive Disorder, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent theta burst transcranial magnetic stimulationDevice
20 iTBS sessions (active or sham) administered over the course of 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active iTBS | Active comparator | Participants will be randomized to active or sham iTBS. Receives: Device: Intermittent theta burst transcranial magnetic stimulation |
| Sham iTBS | Sham comparator | Participants will be randomized to active or sham iTBS. Receives: Device: Intermittent theta burst transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Were Abstinent Through Month 6
Number of particiants in active vs. sham who maintained completed abstinence from alcohol/substance over 6 months post final rTMS session.
Measured: 6 months
Secondary outcomes (4)
Left Dorsolateral Prefrontal Region Glutamate/Creatine Ratio
Left dorsolateral prefrontal region glutamate/creatine ratio pre and post active/sham iTBS. Data were recorded in international units (IU) and converted to Z scores based on the entire sample (unit normal distribution, mean of 0, standard deviation of 1). Higher Z scores (standard deviation above the mean) indicate a greater metabolite concentration ratio and better functioning.
Measured: baseline and follow-up (approximately 2 weeks)
Left Dorsolateral Prefrontal Cortex Thickness
Left dorsolateral prefrontal cortex thickness pre and post active/sham iTBS; hypothesized that increased thickness corresponds to improved cytoarchitectural integrity of the left dorsolateral prefrontal cortex.
Measured: baseline and follow-up (approximately 2 weeks)
General Depressive Symptoms
Beck Depression Inventory-II score pre and post active/sham iTBS (score range, 0 to 63, higher scores indicate more severe symptoms).
Measured: baseline and follow-up (approximately 2 weeks)
Anhedonic Depressive Symptoms
Anhedonic depressive symptoms from Mood and Anxiety Symptom Questionnaire (MASQ, 30-item version; score range: 10 to 50, high scores correspond to more severe symptoms).
Measured: baseline and follow-up (approximately 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start1 Dec 2017
- Primary completion30 Jan 2022
- Study completion30 Jul 2022
Why it stopped: Recruitment difficulties due to Covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Durazzo, PhD, Stanford University
- Investigators
- Timothy C Durazzo, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291431
- Sponsor's protocol ID
- 41896
- Status last verified
- Oct 2023
- First submitted
- 19 Sep 2017
- Last updated
- 16 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Durazzo TC, Humphreys K, LaRocca MA. Leadership Styles Experienced During Military Service Predict Later Anhedonic Depressive Symptoms and Self-Efficacy in Veterans With Alcohol Use Disorder. Mil Med. 2024 May 18;189(5-6):e1064-e1071. doi: 10.1093/milmed/usad405.
PubMed 37897693Durazzo TC, McNerney MW, Hansen AM, Gu M, Sacchet MD, Padula CB. BDNF rs6265 Met carriers with alcohol use disorder show greater age-related decline of N-acetylaspartate in left dorsolateral prefrontal cortex. Drug Alcohol Depend. 2023 Jul 1;248:109901. doi: 10.1016/j.drugalcdep.2023.109901. Epub 2023 Apr 28.
PubMed 37146499
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Theta Burst TMS for the Treatment of Alcohol Use Disorders in Veterans
- ClinicalTrials.gov ID
- NCT03291431
- Acronym / sponsor ID
- 41896
- Conditions
- Alcohol Use Disorder, Depressive Disorder, Cigarette Smoking
- Keywords
- alcohol use disorder, intermittent theta burst, Veterans, depressive disorder, cigarette smoking
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties due to Covid-19 pandemic
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 |
|---|---|---|
| Active iTBS | Active comparator | Device: Intermittent theta burst transcranial magnetic stimulationParticipants will be randomized to active or sham iTBS. |
| Sham iTBS | Sham comparator | Device: Intermittent theta burst transcranial magnetic stimulationParticipants will be randomized to active or sham iTBS. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 21-65 years of age
- Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for alcohol use disorder, and alcohol is self-identified as primary substance of misuse.
- Actively in treatment at VA Palo Alto HCS Addiction Treatment Service
- Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participation in study procedures.
Key exclusion criteria (20 listed)
- History of Schizophrenia Spectrum Disorders, Bipolar Disorders, a
- Current substance use disorder that exceeds the severity of the AUD (based on DSM-5 diagnostic criteria)
- Current use of an FDA approved medication (i.e., disulfiram, acamprosate, and naltrexone) for treatment of AUD,
- Active current suicidal intent or plan (patients with a previous clinical flag for risk for suicide will be required to have an established safety plan involving their primary psychiatrist and the treatment team before entering the clinical trial),
- Any form of previous TMS or electroconvulsive treatment.
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 |
|---|---|---|
| Intermittent theta burst transcranial magnetic stimulation20 iTBS sessions (active or sham) administered over the course of 2 weeks | Device | Active iTBS, Sham iTBS |
Primary outcome
Number of Participants Who Were Abstinent Through Month 6
Time frame: 6 months
Number of particiants in active vs. sham who maintained completed abstinence from alcohol/substance over 6 months post final rTMS session.
4 secondary outcomes
Left Dorsolateral Prefrontal Region Glutamate/Creatine Ratio
Time frame: baseline and follow-up (approximately 2 weeks)
Left Dorsolateral Prefrontal Cortex Thickness
Time frame: baseline and follow-up (approximately 2 weeks)
General Depressive Symptoms
Time frame: baseline and follow-up (approximately 2 weeks)
Anhedonic Depressive Symptoms
Time frame: baseline and follow-up (approximately 2 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37897693Durazzo TC, Humphreys K, LaRocca MA. Leadership Styles Experienced During Military Service Predict Later Anhedonic Depressive Symptoms and Self-Efficacy in Veterans With Alcohol Use Disorder. Mil Med. 2024 May 18;189(5-6):e1064-e1071. doi: 10.1093/milmed/usad405.
- Derived from this study: PubMed 37146499Durazzo TC, McNerney MW, Hansen AM, Gu M, Sacchet MD, Padula CB. BDNF rs6265 Met carriers with alcohol use disorder show greater age-related decline of N-acetylaspartate in left dorsolateral prefrontal cortex. Drug Alcohol Depend. 2023 Jul 1;248:109901. doi: 10.1016/j.drugalcdep.2023.109901. Epub 2023 Apr 28.
- 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.
Timothy C Durazzo, PhD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent theta burst transcranial magnetic stimulation in people with Alcohol Use Disorder and Depressive Disorder, run by Stanford University at 2 sites 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 4 inclusion and 20 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: stopped early, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Were Abstinent Through Month 6 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03291431, which also lists 2 linked publications.
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 Oct 2023.