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aTBS for Treatment of Depression in AUD

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Stanford University

Status

Withdrawn

Conditions

Depression
Alcohol Use Disorder

Treatments

Device: Accelerated theta burst treatment

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Accelerated theta burst treatment
Experimental group
Description:
All participants will receive theta-burst TMS.
Treatment:
Device: Accelerated theta burst treatment

Trial contacts and locations

0

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Central trial contact

Huiqiong Deng, MD, PhD; Romina Nejad, MSc

Data sourced from clinicaltrials.gov

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