Clinical trial NCT04495673: 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
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Heroin Dependence
Morphine Dependence
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-08-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in circuit-based target engagement
timeFrame: baseline; mid-test (week 2±1); post-test (week 3±1)
measure: Change in D-KEFS Trails T-Score
timeFrame: 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)
measure: Change in D-KEFS Verbal Fluency T-Score
timeFrame: 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)
measure: Change in D-KEFS Color Word T-Score
timeFrame: 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)
measure: Change in WAIS Digit Span T-Score
timeFrame: 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)
measure: Change in WAIS Coding T-Score
timeFrame: 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)
measure: Change in Timeline Follow Back (TLFB) Score
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Kelvin Lim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Jazmin Camchong, PhD
role: PRINCIPAL_INVESTIGATOR
References: