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

November 2, 2017 updated by: University of Minnesota
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

October 6, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1508M77345

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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