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

Not Applicable

Withdrawn

• Conditions: Active tDCS; Sham tDCS
• Interventions: Device: Active tDCS stimulation; Device: Sham tDCS stimulation

• Registration Number: NCT02570763
• Lead Sponsor: University of Minnesota

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-06
• Study First Posted: 2015-10-07
• Study Start: 2015-11
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Stimulation	Active tDCS stimulation	Active tDCS administration during the first 20 minutes of each of the six therapy sessions.
Sham Stimulation	Sham tDCS stimulation	Sham tDCS administration during the first 20 minutes of each of six therapy sessions.

Primary Outcome Measures

Name	Time	Method
Therapy Content Memory Assessment	24 hours	Participant's will complete daily assessments of their memory for therapy content from the previous session.