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

NCT02570763 | Withdrawn

• 1 other identifier: 1508M77345
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Active tDCS; Sham tDCS

Keywords

neurostimulation; comorbidity; tDCS; CBT; anxiety; alcohol

Outcome Measures

Primary Outcomes (1)

• Therapy Content Memory Assessment

  Participant's will complete daily assessments of their memory for therapy content from the previous session.

  24 hours

Study Arms (2)

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

Active tDCS stimulation DEVICE

Active Stimulation

Sham tDCS stimulation DEVICE

Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 7, 2015
• Study Start: November 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 6, 2017

Record last verified: 2017-11