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Clinical Intervention in Alcohol Use Disorder

This study is currently recruiting participants.
Verified October 2017 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02168400
First Posted: June 20, 2014
Last Update Posted: October 26, 2017
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.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  Purpose
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 Intervention
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)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Change in Brain Functional Connectivity as measured by functional magnetic resonance imaging [ Time Frame: Change between baseline and 1 week follow-up ]
    Primary Outcome: Investigators will measure magnitude of functional connectivity in between nucleus accumbens (NAcc) and prefrontal cortex (PFC) both at baseline and at follow-up and compare the magnitude of change between the active-tDCS and sham-tDCS groups.


Secondary Outcome Measures:
  • Correlation between functional connectivity change and craving scores [ Time Frame: Data collection will be during 2 and 3 weeks of abstinence ]
    To determine if functional connectivity change induced by tDCS intervention has a short-term effect on behavior related to clinical outcome, investigators will (1) compare change in craving scores (difference in craving scores between 2 and 3 weeks of abstinence) between active-tDCS and sham-tDCS groups and (2) conduct parametric correlations between functional connectivity change and change in craving scores.

  • Correlation between functional connectivity change and clinical outcome [ Time Frame: Between 2 weeks of abstinence and 6 months later ]
    To determine if functional connectivity change induced by tDCS intervention is related to long-term clinical outcome, investigators will record relapse status during the 6 months following treatment discharge. Investigators will examine the relationship between change in NAcc-PFC FC between 2 and 3 weeks of abstinence and subsequent relapse status.


Estimated Enrollment: 20
Study Start Date: July 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20 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).

Exclusion Criteria:

  • any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness of more than 30 min, HIV)
  • any contraindications to MRI scanning (i.e., metal implants, pacemakers, etc.)
  • DSM-V criteria for mental retardation or axis I psychiatric disorder, subjects may have a lifetime but not current diagnosis of depression
  • primary current substance use disorder diagnosis on any substance other than alcohol, except for caffeine or nicotine
  • clinical evidence for Wernicke-Korsakoff syndrome. Nicotine use will be recorded but will not be an exclusion criterion
  Contacts and Locations
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
Contact: Jazmin Camchong, PhD (612) 624-0134

Locations
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 - Clinical and Translational Science Institute
Investigators
Principal Investigator: Jazmin Camchong, PhD University of Minnesota - Clinical and Translational Science Institute