Clinical trial NCT05062369: Tdcs And cogNitive traininG cOmbined for AUD (TANGO)
Official title: Tdcs And cogNitive traininG cOmbined for AUD (TANGO)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Addiction
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overarching goal of this project is to expand the traditional expertise in non-invasive neuromodulation at the University of Minnesota towards developing novel paired-neuromodulation approaches using transcranial direct current stimulation (tDCS) for new treatments for alcohol use disorder (AUD) that support long-term abstinence. This study will allow the investigators to discern whether the pairing of dorsolateral prefrontal cortex (DLPFC) stimulation and cognitive training can lead to improved treatment outcomes as it pertains to executive functioning and maintenance of abstinence. This paired-neuromodulation approach can potentially be used as a therapeutic intervention to decrease relapse probability in addiction. The long-term goal is to develop new addiction treatments that support long-term abstinence. The exploratory goal of this research is to associate genotypes and epigenetic changes with variations in intervention response and clinical outcome. Individual differences in baseline genetic profiles or epigenetic changes over the course of treatment could be associated with treatment response variability.


Eligibility criteria: Inclusion Criteria:

* Meet the Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria for AUD
* Abstinent from alcohol use
* Must have the intention to remain in the Lodging Plus program until the end of the intervention portion of the study.

Exclusion Criteria:

* Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness\>30 min, HIV)
* A head injury resulting in a skull fracture or a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
* Any contraindications for tDCS or MRI scanning (tDCS contraindication: history of seizures; MRI contraindications; metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder)
* Any primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder); Participants with other treated and stable psychiatric disorders will be included
* Presence of a condition that would render study measures difficult or impossible to administer or interpret
* Primary current substance use disorder diagnosis on a substance other than alcohol except for caffeine or nicotine
* Clinical evidence for Wernicke-Korsakoff syndrome
* Left-handedness
* Entrance to the treatment program under a court mandate

Primary outcomes:
measure: Difference in Timeline Followback Questionnaire relapse rates
timeFrame: Up to 4 months post-intervention
measure: Difference in Timeline Followback Questionnaire abstinence period length
timeFrame: Up to 4 months post-intervention
measure: Change in D-KEFS Trail Making (1-5) score
timeFrame: Up to 4 months post-intervention
measure: Change in D-KEFS Color Word score
timeFrame: Up to 4 months post-intervention
measure: Change in Digit Span (WAIS IV) score
timeFrame: Up to 4 months post-intervention
measure: Change in D-KEFS Verbal Frequency score
timeFrame: Up to 4 months post-intervention
measure: Change in Digit Symbol (WAIS IV) score
timeFrame: Up to 4 months post-intervention
measure: Change in functional connectivity
timeFrame: Day 3, Day 9, Day 17, and 1 month
measure: Change in task-evoked functional magnetic resonance signal
timeFrame: Day 3, Day 9, Day 17, and 1 month
measure: Number of transcranial direct current stimulation (tDCS) sessions completed
timeFrame: Days 4-16
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: Univeristy of Minnesota Department of Psychiatry & Behavioral Sciences
name: Jazmin Camchong, PhD
role: PRINCIPAL_INVESTIGATOR
References: