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

University of Minnesota (UMN)

Status: Withdrawn

Conditions: Active tDCS; Sham tDCS

Treatments: Device: Active tDCS stimulation; Device: Sham tDCS stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02570763

1508M77345

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Active Stimulation

Experimental group

Description:

Active tDCS administration during the first 20 minutes of each of the six therapy sessions.

Treatment:

Device: Active tDCS stimulation

Sham Stimulation

Sham Comparator group

Description:

Sham tDCS administration during the first 20 minutes of each of six therapy sessions.

Treatment:

Device: Sham tDCS stimulation