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Clinical Intervention in Alcohol Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168400
Recruitment Status : Recruiting
First Posted : June 20, 2014
Last Update Posted : August 27, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Minnesota

Brief 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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Eligible to go Into the MRI Scanner Short-term Abstinence From Alcohol Use (2 Week Abstinent) Device: Transcranial Direct Current Stimulation (tDCS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Alcohol Use Disorder
Study Start Date : July 2016
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: active tDCS
Subjects that are randomly assigned to this arm will receive 10 active transcranial direct current stimulation (tDCS) sessions
Device: Transcranial Direct Current Stimulation (tDCS)
TDCS will be performed with Neuroelectrics Starstim Enobio 20, an approved research device without an investigational device exemption due to meeting criteria for non-significant risk. It has built-in safety mechanisms which allow for immediate cessation of stimulation if the subject becomes uncomfortable. The current will be administered via two electrode sponges for 25 mins with 1-2 milliamperes. These administration protocols are in line with protocols that have outlined safe administration (Nitsche 2007; 2008). No side-effects have been reported with the exception of slight itching under the electrode and occasional occurrence of headache, fatigue, or nausea (Poreisz 2007). Electrodes placement: dorsolateral prefrontal cortex (DLPFC); cathode on left DLPFC, anode on right DLPFC.
Other Name: Starstim

Sham Comparator: sham tDCS
Subjects randomly assigned to sham-tDCS (transcranial direct current stimulation) will receive very low current stimulation at beginning and end of session, mimicking the feeling of current stimulation in the scalp, but not reaching levels that will stimulate brain function.
Device: Transcranial Direct Current Stimulation (tDCS)
TDCS will be performed with Neuroelectrics Starstim Enobio 20, an approved research device without an investigational device exemption due to meeting criteria for non-significant risk. It has built-in safety mechanisms which allow for immediate cessation of stimulation if the subject becomes uncomfortable. The current will be administered via two electrode sponges for 25 mins with 1-2 milliamperes. These administration protocols are in line with protocols that have outlined safe administration (Nitsche 2007; 2008). No side-effects have been reported with the exception of slight itching under the electrode and occasional occurrence of headache, fatigue, or nausea (Poreisz 2007). Electrodes placement: dorsolateral prefrontal cortex (DLPFC); cathode on left DLPFC, anode on right DLPFC.
Other Name: Starstim




Primary Outcome Measures :
  1. Change in Brain Functional Connectivity [ Time Frame: 1 week ]
    Measured by fMRI scans


Secondary Outcome Measures :
  1. Correlation between functional connectivity change and craving scores [ Time Frame: approximately 1 week ]
    Craving scores from various self report questionnaires in active vs. sham groups and functional connectivity between them.

  2. Correlation between functional connectivity change and clinical outcome [ Time Frame: 8 months ]
    Relapse status at 8 month follow up in active and sham groups

  3. Correlation between genetic variants [ Time Frame: Approximately 8 months ]
    Using saliva collection to analyze genetic variations in groups that relapse and groups that do not



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • up to 75 abstinent individuals (18-45 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 21-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 syndrom
  • left handedness
  • entrance to the treatment program. under court mandate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168400


Contacts
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Contact: Jazmin Camchong, PhD (612) 624-0134

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Jazmin Camchong, PhD    612-624-0134    camch002@umn.edu   
Principal Investigator: Jazmin Camchong, PhD         
Sub-Investigator: Kelvin O Lim, MD         
Sponsors and Collaborators
University of Minnesota
National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Jazmin Camchong, PhD University of Minnesota
Publications:

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02168400    
Other Study ID Numbers: PSYCH-2016-22561
K01AA026349 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders