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Neuromodulation and Cognitive Training in Opioid Use Disorder

Primary Purpose

Opioid-use Disorder, Opioid Dependence, Opioid Abuse

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcranial Direct Current Stimulation (tDCS)

About this trial

This is an interventional device feasibility trial for Opioid-use Disorder focused on measuring tDCS, Transcranial Direct Current Stimulation, MRI, Opioid dependence, Opioids, Buprenorphine, Suboxone, Lodging Plus, Fairview Lodging Plus

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental: active tDCS

Sham Comparator: sham tDCS

Arm Description

Subjects that are randomly assigned to this arm will undergo 5 sessions of 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.

Outcomes

Primary Outcome Measures

Change in brain functional connectivity as measured by functional magnetic resonance imaging

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

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

Investigators will record relapse status during the 2 months following treatment discharge.

Full Information

NCT ID

NCT03773523

First Posted

December 10, 2018

Last Updated

March 6, 2023

Sponsor

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT03773523

Brief Title

Neuromodulation and Cognitive Training in Opioid Use Disorder

Official Title

Neuromodulation and Cognitive Training in Opioid Use Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2019 (Actual)

Primary Completion Date

October 1, 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-use Disorder, Opioid Dependence, Opioid Abuse

Keywords

tDCS, Transcranial Direct Current Stimulation, MRI, Opioid dependence, Opioids, Buprenorphine, Suboxone, Lodging Plus, Fairview Lodging Plus

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This study is randomized, double-blind, and sham-controlled. Participants will be randomly assigned to either active or sham tDCS.

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: active tDCS

Arm Type

Experimental

Arm Description

Subjects that are randomly assigned to this arm will undergo 5 sessions of tDCS.

Arm Title

Sham Comparator: sham tDCS

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Transcranial Direct Current Stimulation (tDCS)

Other Intervention Name(s)

Starstim

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in brain functional connectivity as measured by functional magnetic resonance imaging

Description

Time Frame

Change between baseline and 1-week follow-up

Secondary Outcome Measure Information:

Title

Correlation between functional connectivity change and craving scores

Description

Time Frame

Data collection will be during 2 and 3 weeks of abstinence

Title

Correlation between functional connectivity change and clinical outcome

Description

Investigators will record relapse status during the 2 months following treatment discharge.

Time Frame

Between 2 weeks of abstinence and 2 months later

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jazmin Y Camchong, PhD

Phone

(612) 624-0134

camch002@umn.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Lamisa N Chowdhury, BS

Phone

(612) 626-6808

chow0082@umn.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jazmin Y Camchong, PhD

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kelvin O Lim, MD

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55414

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jazmin Y Camchong, PhD

Phone

612-624-0134

camch002@umn.edu

First Name & Middle Initial & Last Name & Degree

Jazmin Y Camchong, PhD

First Name & Middle Initial & Last Name & Degree

Kelvin O Lim, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

24745476

Citation

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.

Results Reference

background

PubMed Identifier

22819968

Citation

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.

Results Reference

background

PubMed Identifier

23421812

Citation

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.

Results Reference

background

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Neuromodulation and Cognitive Training in Opioid Use Disorder

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