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

Sham tDCS Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02570763
• Other study ID #: 1508M77345
• Status: Withdrawn
• Phase: N/A
• First received: October 6, 2015
• Last updated: November 2, 2017
• Start date: November 2015
• Est. completion date: July 2016

Study information

• Verified date: November 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Active tDCS
• Sham tDCS

Intervention

Device:
• Active tDCS stimulation

• Sham tDCS stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapy Content Memory Assessment	Participant's will complete daily assessments of their memory for therapy content from the previous session.	24 hours