Combining Non-Invasive Brain Stimulation With Cognitive Behavioral Intervention in Substance Use Disorder

Study Overview
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Brief Summary
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The current study aims to examine the safety and feasibility of utilizing tDCS to enhance affect-laden episodic memory consolidation among adults with co-occurring alcohol use and anxiety disorders who have recently undergone detoxification as a step toward the translational clinical application of this approach.

Conditions
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Active tDCS, Sham tDCS

Intervention / Treatment
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* Device: Active tDCS stimulation
* Device: Sham tDCS stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM IV diagnosis of panic disorder (with or without agoraphobia), generalized anxiety disorder, or social anxiety disorder within the past 30 days DSM IV diagnosis of alcohol dependence within the last 30 days inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug) dependence alcohol use in the 30 days preceding the study willingness to provide informed consent minimum of a sixth grade English reading level (deemed necessary to complete study materials); as determined by their being able to read and understand the consent form. Living within reasonable driving distance (1 hour or less) of the Twin Cities to allow for in-person follow-up interviews Exclusion Criteria: lifetime history of psychosis or mania by history. cognitive (e.g., dementia) or physical impairment (e.g., blindness) that interferes with study participation report or as judged by PI/study physician. Current suicide risk as deemed by the PI and study physician to be serious and ongoing any medical condition or treatment with neurological sequelae (e.g., stroke, tumor, loss of consciousness of more than 30 minutes, HIV, seizures) history of ECT document loss of consciousness (LOC) for longer than 30 minutes or LOC with neurological sequelae pregnancy Although seizures are not a known risk of tDCS intervention (Fregni et al., 2006; Nitsche et al., 2008), anyone with a history or a risk for seizures will be excluded from the study anyone with metal objects implanted in their head or neck anyone taking stimulant medications for any reason as we wish to avoid two sorces of neurostimulation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Stimulation<br>Active tDCS administration during the first 20 minutes of each of the six therapy sessions. | Device: Active tDCS stimulation<br> <br> |
| Sham Comparator: Sham Stimulation<br>Sham tDCS administration during the first 20 minutes of each of six therapy sessions. | Device: Sham tDCS stimulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy Content Memory Assessment | Participant's will complete daily assessments of their memory for therapy content from the previous session. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurostimulation, comorbidity, tDCS, CBT, anxiety, alcohol