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Neuromodulation and Cognitive Training in Opioid 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: NCT03773523
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
The relapsing nature of opioid use disorder is a major obstacle to successful treatment. About 90% of those entering treatment will relapse within one year. To improve treatment outcome, new interventions targeting the underlying brain biomarkers of relapse vulnerability hold significant promise in reducing this critical public health problem. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that can modulate brain connectivity.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Opioid Dependence Opioid Abuse Device: Transcranial Direct Current Stimulation (tDCS) Not Applicable

Detailed Description:

Cognitive flexibility, the ability to change maladaptive behavior, depends on dorsolateral prefrontal cortex (DLPFC) input to the nucleus accumbens (NAcc; Gruber, Hussain, and O'Donnell 2009). DLPFC stimulation may increase input to NAcc to facilitate proper selection of goal-directed behavior and may also decrease craving in individuals with substance use disorder (Boggio et al. 2008).

We will use transcranial direct current stimulation (tDCS) to stimulate the DLPFC. TDCS is a non-invasive brain stimulation technique that can modulate brain connectivity. TDCS involves applying a weak electrical current (2mA or less) to the scalp via anodal and cathodal electrode sponges, causing either increases or decreases in cortical excitability, respectively. Research has shown in both healthy subjects and patients (e.g. Alzheimer's disease, Parkinson's disease, stroke, and depression) that tDCS has the potential to modulate synaptic strengthening and neurotransmitter-dependent plasticity underlying changes in behavior and learning (Lang et al. 2005).

We are anticipating enrollment of 30 participants. Fifteen participants will be randomly assigned to the interventional tDCS condition, while 15 participants will be randomly assigned to sham tDCS. Both conditions will undergo five sessions of tDCS across five days. Participants will undergo pre- and post-tDCS MRI scans, in addition to clinical interviews and questionnaires. Follow-up interviews will be conducted in person 1 and 2 months after intervention completion to inquire about relapse status.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is randomized, double-blind, and sham-controlled. Participants will be randomly assigned to either active or sham tDCS.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Participants will not be informed on their assigned protocol. During consent, they will be informed that there is a 50% chance of being assigned either to the group receiving active tDCS or the group receiving sham tDCS.

The Principal Investigator and research staff will also be blind to the condition the participant is assigned to.

Primary Purpose: Device Feasibility
Official Title: Neuromodulation and Cognitive Training in Opioid Use Disorder
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental: active tDCS
Subjects that are randomly assigned to this arm will undergo 5 sessions of tDCS.
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 Comparator: sham tDCS
Subjects randomly assigned to sham-tDCS will receive very low current stimulation at the beginning and end of the session, mimicking the feeling of current stimulation in the scalp, but not reaching levels that will stimulate brain function. There will be a total of 5 sham 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




Primary Outcome Measures :
  1. Change in brain functional connectivity as measured by functional magnetic resonance imaging [ Time Frame: Change between baseline and 1-week follow-up ]
    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 :
  1. Correlation between functional connectivity change and craving scores [ Time Frame: Data collection will be during 2 and 3 weeks of abstinence ]
    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.

  2. Correlation between functional connectivity change and clinical outcome [ Time Frame: Between 2 weeks of abstinence and 2 months later ]
    Investigators will record relapse status during the 2 months following treatment discharge.



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:   No
Criteria

Inclusion Criteria:

  • 20 abstinent individuals (18-60 years old; 1-2 weeks of abstinence) who meet DSM-V criteria for opioid use disorder (OUD) 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 individuals with OUD in which patients receive random drug screenings. Lodging Plus has 50 beds and admits an average of 20 patients per week and about 50% of patients admitted have a diagnosis of opioid 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 OUD. Subjects may have current comorbid drug use, but their primary substance use disorder diagnosis needs to be based on opioid use. Subjects must have the intention to remain in the Lodging Plus program (4 weeks) until the end of the intervention portion of the study. Vulnerable populations will not be included.

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)
  • DSM-V criteria for psychiatric disorder, may have a lifetime diagnosis of depression
  • Presence of a condition that would render study measures difficult or impossible to administer or interpret
  • Age outside the range of 18 to 60
  • Primary current substance use disorder diagnosis on a substance other than opioid except for caffeine or nicotine
  • Clinical evidence for Wernicke-Korsakoff syndrome
  • Nicotine use will be recorded.

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): NCT03773523


Contacts
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Contact: Jazmin Y Camchong, PhD (612) 624-0134 camch002@umn.edu
Contact: Lamisa N Chowdhury, BS (612) 626-6808 chow0082@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Jazmin Y Camchong, PhD    612-624-0134    camch002@umn.edu   
Principal Investigator: Jazmin Y Camchong, PhD         
Sub-Investigator: Kelvin O Lim, MD         
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Jazmin Y Camchong, PhD University of Minnesota
Principal Investigator: Kelvin O Lim, MD University of Minnesota
Publications:
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03773523    
Other Study ID Numbers: PSYCH-2018-27116
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Minnesota:
tDCS
Transcranial Direct Current Stimulation
MRI
Opioid dependence
Opioids
Buprenorphine
Suboxone
Lodging Plus
Fairview Lodging Plus
Additional relevant MeSH terms:
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Substance-Related Disorders
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders