Clinical Intervention in Alcohol Use Disorder

NCT02168400 | Completed Results DMC

• 2 other identifiers: PSYCH-2016-22561K01AA026349
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder; Eligible to go Into the MRI Scanner; Short-term Abstinence From Alcohol Use (2 Week Abstinent)

Outcome Measures

Primary Outcomes (1)

• Intervention Effects on Brain Functional Connectivity

  Compared mean change in brain functional connectivity (measured at two timepoints, at pre-intervention and at post-intervention) between Active tDCS and Sham groups.

  1 week

Secondary Outcomes (1)

• Correlation Between Functional Connectivity Change and Clinical Outcome (Length of Abstinence)

  8 months

Study Arms (2)

active tDCS

EXPERIMENTAL

Subjects that are randomly assigned to this arm will receive 10 active transcranial direct current stimulation (tDCS) sessions

Device: Transcranial Direct Current Stimulation (tDCS)

sham tDCS

SHAM COMPARATOR

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)

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

tDCS will be performed with Neuroelectrics Starstim Enobio 20, a non-invasive investigational device that has been labeled as a non-significant risk device by the FDA. This study is regulated by the FDA as an Abbreviated IDE. 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.

Also known as: Starstim

active tDCS; sham tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (13)

• Camchong J, Macdonald AW 3rd, Mueller BA, Nelson B, Specker S, Slaymaker V, Lim KO. Changes in resting functional connectivity during abstinence in stimulant use disorder: a preliminary comparison of relapsers and abstainers. Drug Alcohol Depend. 2014 Jun 1;139:145-51. doi: 10.1016/j.drugalcdep.2014.03.024. Epub 2014 Mar 29.

  PMID: 24745476 BACKGROUND

• Camchong J, Stenger A, Fein G. Resting-state synchrony during early alcohol abstinence can predict subsequent relapse. Cereb Cortex. 2013 Sep;23(9):2086-99. doi: 10.1093/cercor/bhs190. Epub 2012 Jul 20.

  PMID: 22819968 BACKGROUND

• Camchong J, Stenger VA, Fein G. Resting-state synchrony in short-term versus long-term abstinent alcoholics. Alcohol Clin Exp Res. 2013 May;37(5):794-803. doi: 10.1111/acer.12037. Epub 2013 Feb 19.

  PMID: 23421812 BACKGROUND

• Ballard K, Knutson B. Dissociable neural representations of future reward magnitude and delay during temporal discounting. Neuroimage. 2009 Mar 1;45(1):143-50. doi: 10.1016/j.neuroimage.2008.11.004. Epub 2008 Nov 24.

  PMID: 19071223 BACKGROUND

• Boggio PS, Sultani N, Fecteau S, Merabet L, Mecca T, Pascual-Leone A, Basaglia A, Fregni F. Prefrontal cortex modulation using transcranial DC stimulation reduces alcohol craving: a double-blind, sham-controlled study. Drug Alcohol Depend. 2008 Jan 1;92(1-3):55-60. doi: 10.1016/j.drugalcdep.2007.06.011. Epub 2007 Jul 19.

  PMID: 17640830 BACKGROUND

• D'Cruz AM, Ragozzino ME, Mosconi MW, Pavuluri MN, Sweeney JA. Human reversal learning under conditions of certain versus uncertain outcomes. Neuroimage. 2011 May 1;56(1):315-22. doi: 10.1016/j.neuroimage.2011.01.068. Epub 2011 Jan 28.

  PMID: 21281720 BACKGROUND

• Gruber AJ, Hussain RJ, O'Donnell P. The nucleus accumbens: a switchboard for goal-directed behaviors. PLoS One. 2009;4(4):e5062. doi: 10.1371/journal.pone.0005062. Epub 2009 Apr 7.

  PMID: 19352511 BACKGROUND

• Klauss J, Penido Pinheiro LC, Silva Merlo BL, de Almeida Correia Santos G, Fregni F, Nitsche MA, Miyuki Nakamura-Palacios E. A randomized controlled trial of targeted prefrontal cortex modulation with tDCS in patients with alcohol dependence. Int J Neuropsychopharmacol. 2014 Nov;17(11):1793-803. doi: 10.1017/S1461145714000984. Epub 2014 Jul 10.

  PMID: 25008145 BACKGROUND

• Lang N, Siebner HR, Ward NS, Lee L, Nitsche MA, Paulus W, Rothwell JC, Lemon RN, Frackowiak RS. How does transcranial DC stimulation of the primary motor cortex alter regional neuronal activity in the human brain? Eur J Neurosci. 2005 Jul;22(2):495-504. doi: 10.1111/j.1460-9568.2005.04233.x.

  PMID: 16045502 BACKGROUND

• Monte-Silva K, Kuo MF, Hessenthaler S, Fresnoza S, Liebetanz D, Paulus W, Nitsche MA. Induction of late LTP-like plasticity in the human motor cortex by repeated non-invasive brain stimulation. Brain Stimul. 2013 May;6(3):424-32. doi: 10.1016/j.brs.2012.04.011. Epub 2012 Jun 2.

  PMID: 22695026 BACKGROUND

• Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.

  PMID: 20633386 BACKGROUND

• Nitsche MA, Doemkes S, Karakose T, Antal A, Liebetanz D, Lang N, Tergau F, Paulus W. Shaping the effects of transcranial direct current stimulation of the human motor cortex. J Neurophysiol. 2007 Apr;97(4):3109-17. doi: 10.1152/jn.01312.2006. Epub 2007 Jan 24.

  PMID: 17251360 BACKGROUND

• Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.

  PMID: 17452283 BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Jazmin Camchong
• Organization: University of Minnesota

camch002@umn.edu

(612) 625-3330

Study Officials

• Jazmin Camchong, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 20, 2014
• Study Start: July 7, 2016
• Primary Completion: November 17, 2022
• Study Completion: November 17, 2022
• Last Updated: June 5, 2024
• Results First Posted: June 5, 2024

Record last verified: 2024-06

Locations

US (1)