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

NCT ID: NCT02570763

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active Stimulation

Active tDCS administration during the first 20 minutes of each of the six therapy sessions.

Group Type: EXPERIMENTAL

Active tDCS stimulation

Intervention Type: DEVICE

Sham Stimulation

Sham tDCS administration during the first 20 minutes of each of six therapy sessions.

Group Type: SHAM_COMPARATOR

Sham tDCS stimulation

Intervention Type: DEVICE

Interventions

Active tDCS stimulation

Intervention Type: DEVICE

Sham tDCS stimulation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1508M77345

Identifier Type: -

Identifier Source: org_study_id