Clinical trial NCT03981185: aTBS for Treatment of Depression in AUD
Official title: Accelerated Theta Burst Stimulation for Treatment of Depression in Individuals With Detoxed Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alcohol Use Disorder
Depression
Keywords: depression
TMS
transcranial magnetic stimulation
theta burst
alcohol use disorder
alcohol addiction
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 1. Participant aged 18-65 years old with diagnosis of alcohol use disorder.
2. Participant may also choose to or not to take pharmacotherapy during the study period.
3. 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.
4. 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.
5. Participant endorses depressive symptom(s), indicated by a MARDS score \>= 20.
6. All participants must be assigned to a psychiatrist and agree to continue to be assigned to a psychiatrist throughout study enrollment.
7. 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.

Primary outcomes:
measure: Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline and immediate post-stimulation
measure: Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline and 1 month post-stimulation
Secondary outcomes:
measure: Change in functional connectivity from baseline as measured by MR imaging
timeFrame: Baseline and immediate post-stimulation
measure: Change in functional connectivity from baseline as measured by MR imaging
timeFrame: Baseline and 1 month post-stimulation
measure: Change in alcohol craving and consumption measured by Obsessive Compulsive Drinking Scale (OCDS)
timeFrame: Baseline and immediate post-stimulation
measure: Change in alcohol craving and consumption measured by Obsessive Compulsive Drinking Scale (OCDS)
timeFrame: Baseline and 1 month post-stimulation
measure: Change in heart rate variability
timeFrame: At the beginning and end of each stimulation day
Other outcomes:
measure: Change from baseline in the Delis Kaplan Executive Function System (D-KEFS): Trail Making Test
timeFrame: Baseline and immediate post-stimulation
measure: Change from baseline in the Delis Kaplan Executive Function System (D-KEFS): Trail Making Test
timeFrame: Baseline and 1 month post-stimulation
measure: Change from baseline in the Hopkins Verbal Learning Test- Revised (HVLT-R)
timeFrame: Baseline and immediate post-stimulation
measure: Change from baseline in the Hopkins Verbal Learning Test- Revised (HVLT-R)
timeFrame: Baseline and 1 month post-stimulation
measure: Change from baseline in the Brief Visuospatial Memory Test - Revised (BVMT-R)
timeFrame: Baseline and immediate post-stimulation
measure: Change from baseline in the Brief Visuospatial Memory Test - Revised (BVMT-R)
timeFrame: Baseline and 1-month post-stimulation
measure: Change from baseline in the Advanced Clinical Solutions Test of Premorbid Function (TOPF)
timeFrame: Baseline and immediate post-stimulation
measure: Change from baseline in the Advanced Clinical Solutions Test of Premorbid Function (TOPF)
timeFrame: Baseline and 1-month post-stimulation
Locations:
Study officials:
affiliation: Stanford University
name: Nolan Williams, MD
role: PRINCIPAL_INVESTIGATOR
References: