N/A
N=75
Clinical Intervention in Alcohol Use Disorder
Alcohol Use Disorder · Eligible to go Into the MRI Scanner · Short-term Abstinence From Alcohol Use (2 Week Abstinent)
Bottom Line
View on ClinicalTrials.gov: NCT02168400 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Intervention Effects on Brain Functional Connectivity — 0.05; 0.19 percentage of Blood Oxygenation Level De
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Direct Current Stimulation (tDCS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intervention Effects on Brain Functional Connectivity |
0.05; 0.19 | — |
| SECONDARY Correlation Between Functional Connectivity Change and Clinical Outcome (Length of Abstinence) |
0.03; 0.16 | — |
Summary
Long-term abstinence from alcohol is supported by a compensatory mechanism in functional brain connectivity, a potential brain biomarker that could be an intervention target. These findings provide a compelling case to explore whether this brain biomarker can be modulated to enhance patients' ability to remain abstinent. There is a need to investigate methods that can be used to increase functional brain connectivity. The overall objective of this proposal is to enhance brain functional connectivity in short-term abstinent alcoholics as a therapeutic intervention that supports abstinence.
Eligibility Criteria
Inclusion Criteria
- up to 75 abstinent individuals (18-65 years old; 2 weeks of abstinence) who meet DSM-V criteria for alcohol use disorder (AUD) will be recruited from the Lodging Plus Program, part of University of Minnesota Medical Center
- This 28-day program provides a supervised environment to treat alcoholism in which patients receive random drug/alcohol screenings daily. Lodging Plus has 50 beds and admits an average of 20 patients per week and 59% of patients admitted have a diagnosis of alcohol use disorder.
Inclusion criteria
- ability to provide written consent and comply with study procedures
- meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for AUD. Subjects may have current comorbid drug use, but their primary substance use disorder diagnosis needs to be based on alcohol use. Subjects must have the intention to remain in program until the end of the study (3 weeks). Vulnerable populations will not be included
Exclusion Criteria
- any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness of more than 30 min, HIV)
- a head injury resulting in a skull fracture or loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
- any contraindications for tDCS or MRI scanning (tDCS contraindications: 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
- age outside the range of 18 to 65
- primary current substance use disorder diagnosis on a substance other than alcohol except for caffeine or nicotine
- clinical evidence of Wernicke-Karsakoff syndrome
- left handedness
- entrance to the treatment program. under court mandate
Data sourced from ClinicalTrials.gov (NCT02168400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.