Combining Non-Invasive Brain Stimulation With Cognitive B... | NCT02570763

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

NCT02570763

Sponsor

University of Minnesota

Status

Withdrawn

Last Update Posted

Nov 6, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Active tDCS
Sham tDCS

Interventions

Active tDCS stimulation
Sham tDCS stimulation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The co-investigator and recipient of funding for the project left the department and we were unable to complete the study without her as a co-investigator.

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Jul 2016Estimated

Completion Date

Jul 2016Estimated

First Submitted Date

Oct 6, 2015

First Submission Date that Met QC Criteria

Oct 6, 2015

First Posted Date

Oct 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2017

Last Update Posted Date

Nov 6, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active Stimulation	Experimental	Active tDCS administration during the first 20 minutes of each of the six therapy sessions.	Device: Active tDCS stimulation
Sham Stimulation	Sham Comparator	Sham tDCS administration during the first 20 minutes of each of six therapy sessions.	Device: Sham tDCS stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Active tDCS stimulation	Device		Active Stimulation
Sham tDCS stimulation

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided