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

Not Applicable

Completed

• Conditions: Morphine Dependence; Opioid-Related Disorders; Heroin Dependence
• Interventions: Device: Transcranial Direct Current Stimulation (tDCS); Device: Sham Transcranial Direct Current Stimulation (tDCS); Behavioral: Cognitive Training

• Registration Number: NCT04495673
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-08-03
• Study Start: 2021-01-11
• Primary Completion: 2022-02-22
• Study Completion: 2022-02-22
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-27
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tDCS with Cognitive Training	Transcranial Direct Current Stimulation (tDCS)	DLPFC stimulation with tDCS with simultaneous cognitive training
tDCS with Cognitive Training	Cognitive Training	DLPFC stimulation with tDCS with simultaneous cognitive training
Sham tDCS with Cognitive Training	Sham Transcranial Direct Current Stimulation (tDCS)	Sham tDCS with simultaneous cognitive training
Sham tDCS with Cognitive Training	Cognitive Training	Sham tDCS with simultaneous cognitive training

Primary Outcome Measures

Name	Time	Method
Change in D-KEFS Color Word T-Score	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)	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.
Changes in circuit-based target engagement	baseline; mid-test (week 2±1); post-test (week 3±1)	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 WAIS Coding T-Score	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)	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 D-KEFS Verbal Fluency T-Score	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)	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 Trails T-Score	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)	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 WAIS Digit Span T-Score	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)	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 Timeline Follow Back (TLFB) Score	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)	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States