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Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder

Primary Purpose

Opioid-Related Disorders, Heroin Dependence, Morphine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation (tDCS)
Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive Training
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Related Disorders

Eligibility Criteria

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

Inclusion Criteria:

  • Current diagnosis of opioid use disorder
  • Enrolled in a methadone treatment program for at least 2 months in Hennepin Healthcare and be clinically stable.
  • Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for opioid use disorder
  • Participants may have current comorbid drug use, but their primary substance use disorder diagnosis must to be based on opioid use.
  • Participants must have the intention to remain in the methadone treatment program until the end of the intervention portion of the study.

Exclusion Criteria:

  • Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness>30 min, HIV)
  • 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: actively receiving treatment for seizures or epilepsy; 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)
  • Current active psychosis or mania
  • Presence of a condition that would render study measures difficult or impossible to administer or interpret (e.g. current mania, active psychosis)
  • Primary current substance use disorder diagnosis on a substance other than opioid except for caffeine or nicotine
  • Current stimulant use disorder (need to be free of stimulant use for at least 1 month)
  • History of electroconvulsive therapy or cortical energy exposure within the past 12 months, including participation in any other neuromodulation studies
  • incarceration

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tDCS with Cognitive Training

Sham tDCS with Cognitive Training

Arm Description

DLPFC stimulation with tDCS with simultaneous cognitive training

Sham tDCS with simultaneous cognitive training

Outcomes

Primary Outcome Measures

Changes in circuit-based target engagement
Participants will complete MRI sessions on a 3T scanner located in the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota. Participants will undergo resting-state MRI over an 8-minute scan in order to gather resting state functional connectivity. Significant within-subject increase (p<.05, 1-tailed) in signal intensity (unitless measure) resting state functional connectivity (rsFC) of at least one frontally mediated network (frontal-striatal, frontal-insular, frontal-thalamic) in Active and Sham arms.
Change in D-KEFS Trails T-Score
The Trails subtest measures switching. The participant is presented with a sheet with several letters or numbers and is asked to follow the prompts (e.g. connect alternating numbers and letters). The time and number of errors for each of the 5 sheets is recorded and a T-score (range: 1-20) is calculated from this information. A higher T-score indicates higher capacity for switching, i.e., a better outcome.
Change in D-KEFS Verbal Fluency T-Score
The Verbal Fluency subtest measures executive control. Participants have to produce as many words as possible from a category in 60 seconds. The number of words produced and the number/position/type of errors are recorded. A T-score (range: 1-20) is calculated from this information. A higher T-score indicates higher executive control, i.e., a better outcome.
Change in D-KEFS Color Word T-Score
The Color-Word subtest measures switching capacity. The participant is presented with words demonstrating a mismatch between the name of a color (e.g., "blue", "green", or "red") and the color it is printed on (i.e., the word "red" printed in blue ink instead of red ink). The participant must follow the prompts (e.g. "Say the color of the ink this time") when responding. The number of correct answers and the time taken to complete the task are recorded, generating a T-score (range: 1-20). A higher T-score indicates higher capacity for switching i.e., a better outcome.
Change in WAIS Digit Span T-Score
The Digit Span subtest measures working memory. The participant is prompted to recall the order of digits they just heard (e.g., same order, backwards order, sequential order). There are two trials per item. Each item increases the difficulty by adding one digit. The total number correct generates a T-score (range: 1-20). A higher T-score indicates higher capacity for working memory, i.e., a better outcome.
Change in WAIS Coding T-Score
The Coding subtest measures switching capacity. The participant is presented with a symbol for each digit 1-9 (e.g., an upside-down "T" represents the number 2). The participant must translate the numbers into symbols, as fast as they can, for 120 seconds. The number of correctly-drawn symbols generates a T-score (range: 1-20). A higher T-score indicates higher capacity for switching, i.e., a better outcome.
Change in Timeline Follow Back (TLFB) Score
The TLFB questionnaire measures substance use disorder severity. The questionnaire asks the participant about substance use in the past 30 days. The participant reports on a binary scale as to whether or not they have used a given substance. A greater number of days with drug use in the past month the participant used a substance equals a higher score. A higher score equals greater substance use disorder severity.

Secondary Outcome Measures

Full Information

First Posted
July 28, 2020
Last Updated
December 27, 2022
Sponsor
University of Minnesota
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04495673
Brief Title
Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder
Official Title
Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
February 22, 2022 (Actual)
Study Completion Date
February 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The overarching goal of this project is to expand the traditional expertise in non-invasive neuromodulation at the University of Minnesota towards developing novel paired-neuromodulation approaches using transcrancial direct current stimulation (tDCS) for new addiction treatments that support long-term abstinence. This study will investigate whether the pairing of dorsolateral prefrontal cortex (DLPFC) stimulation and cognitive training can enhance functional connectivity between DLPFC and nucleus accumbens (NAcc). We have identified higher functional connectivity between DLPFC and NAcc in alcoholics that have successfully maintained abstinence for extended periods of time (7 years). This paired-neuromodulation approach can potentially be used as a therapeutic intervention to decrease substance use probability in addiction (e.g. opioid use disorder). The long term goal is to develop new addiction treatments that support long-term abstinence in opioid use disorder. The overall objective of this proposal is to enhance functional connectivity between DLPFC and NAcc as a therapeutic intervention to enhance cognition and reduce substance use rates in opioid use disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Heroin Dependence, Morphine Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS with Cognitive Training
Arm Type
Experimental
Arm Description
DLPFC stimulation with tDCS with simultaneous cognitive training
Arm Title
Sham tDCS with Cognitive Training
Arm Type
Active Comparator
Arm Description
Sham tDCS with simultaneous cognitive training
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)
Intervention Description
Participants receive 10 sessions (2 5-visit blocks of 46 minutes) of active tDCS to DLPFC (dorsolateral prefrontal cortex)
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Direct Current Stimulation (tDCS)
Intervention Description
Participants receive 10 sessions (1 5-visit block of 46 minutes of active tDCS and 1 5-visit block of sham tDCS)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
Executive functioning tasks
Primary Outcome Measure Information:
Title
Changes in circuit-based target engagement
Description
Participants will complete MRI sessions on a 3T scanner located in the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota. Participants will undergo resting-state MRI over an 8-minute scan in order to gather resting state functional connectivity. Significant within-subject increase (p<.05, 1-tailed) in signal intensity (unitless measure) resting state functional connectivity (rsFC) of at least one frontally mediated network (frontal-striatal, frontal-insular, frontal-thalamic) in Active and Sham arms.
Time Frame
baseline; mid-test (week 2±1); post-test (week 3±1)
Title
Change in D-KEFS Trails T-Score
Description
The Trails subtest measures switching. The participant is presented with a sheet with several letters or numbers and is asked to follow the prompts (e.g. connect alternating numbers and letters). The time and number of errors for each of the 5 sheets is recorded and a T-score (range: 1-20) is calculated from this information. A higher T-score indicates higher capacity for switching, i.e., a better outcome.
Time Frame
baseline; mid-test (week 2±1); post-test (week 3±1); Follow-up 1 (post-test + 1 month), Follow-up 2 (post-test + 2 months)
Title
Change in D-KEFS Verbal Fluency T-Score
Description
The Verbal Fluency subtest measures executive control. Participants have to produce as many words as possible from a category in 60 seconds. The number of words produced and the number/position/type of errors are recorded. A T-score (range: 1-20) is calculated from this information. A higher T-score indicates higher executive control, i.e., a better outcome.
Time Frame
baseline; mid-test (week 2±1); post-test (week 3±1); Follow-up 1 (post-test + 1 month), Follow-up 2 (post-test + 2 months)
Title
Change in D-KEFS Color Word T-Score
Description
The Color-Word subtest measures switching capacity. The participant is presented with words demonstrating a mismatch between the name of a color (e.g., "blue", "green", or "red") and the color it is printed on (i.e., the word "red" printed in blue ink instead of red ink). The participant must follow the prompts (e.g. "Say the color of the ink this time") when responding. The number of correct answers and the time taken to complete the task are recorded, generating a T-score (range: 1-20). A higher T-score indicates higher capacity for switching i.e., a better outcome.
Time Frame
Time Frame: baseline; mid-test (week 2±1); post-test (week 3±1); Follow-up 1 (post-test + 1 month), Follow-up 2 (post-test + 2 months)
Title
Change in WAIS Digit Span T-Score
Description
The Digit Span subtest measures working memory. The participant is prompted to recall the order of digits they just heard (e.g., same order, backwards order, sequential order). There are two trials per item. Each item increases the difficulty by adding one digit. The total number correct generates a T-score (range: 1-20). A higher T-score indicates higher capacity for working memory, i.e., a better outcome.
Time Frame
baseline; mid-test (week 2±1); post-test (week 3±1); Follow-up 1 (post-test + 1 month), Follow-up 2 (post-test + 2 months)
Title
Change in WAIS Coding T-Score
Description
The Coding subtest measures switching capacity. The participant is presented with a symbol for each digit 1-9 (e.g., an upside-down "T" represents the number 2). The participant must translate the numbers into symbols, as fast as they can, for 120 seconds. The number of correctly-drawn symbols generates a T-score (range: 1-20). A higher T-score indicates higher capacity for switching, i.e., a better outcome.
Time Frame
baseline; mid-test (week 2±1); post-test (week 3±1); Follow-up 1 (post-test + 1 month), Follow-up 2 (post-test + 2 months)
Title
Change in Timeline Follow Back (TLFB) Score
Description
The TLFB questionnaire measures substance use disorder severity. The questionnaire asks the participant about substance use in the past 30 days. The participant reports on a binary scale as to whether or not they have used a given substance. A greater number of days with drug use in the past month the participant used a substance equals a higher score. A higher score equals greater substance use disorder severity.
Time Frame
baseline; mid-test (week 2±1); post-test (week 3±1); Follow-up 1 (post-test + 1 month), Follow-up 2 (post-test + 2 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Current diagnosis of opioid use disorder Enrolled in a methadone treatment program for at least 2 months in Hennepin Healthcare and be clinically stable. Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for opioid use disorder Participants may have current comorbid drug use, but their primary substance use disorder diagnosis must to be based on opioid use. Participants must have the intention to remain in the methadone treatment program until the end of the intervention portion of the study. Exclusion Criteria: Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness>30 min, HIV) 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: actively receiving treatment for seizures or epilepsy; 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) Current active psychosis or mania Presence of a condition that would render study measures difficult or impossible to administer or interpret (e.g. current mania, active psychosis) Primary current substance use disorder diagnosis on a substance other than opioid except for caffeine or nicotine Current stimulant use disorder (need to be free of stimulant use for at least 1 month) History of electroconvulsive therapy or cortical energy exposure within the past 12 months, including participation in any other neuromodulation studies incarceration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelvin Lim, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jazmin Camchong, PhD
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
55455
Country
United States

12. IPD Sharing Statement

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Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder

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