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

NCT ID: NCT04495673

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-11
• Study Completion Date: 2022-02-22

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.

Conditions

Opioid-Related Disorders; Heroin Dependence; Morphine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

tDCS with Cognitive Training

DLPFC stimulation with tDCS with simultaneous cognitive training

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

Participants receive 10 sessions (2 5-visit blocks of 46 minutes) of active tDCS to DLPFC (dorsolateral prefrontal cortex)

Cognitive Training

Intervention Type: BEHAVIORAL

Executive functioning tasks

Sham tDCS with Cognitive Training

Sham tDCS with simultaneous cognitive training

Group Type: ACTIVE_COMPARATOR

Sham Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

Participants receive 10 sessions (1 5-visit block of 46 minutes of active tDCS and 1 5-visit block of sham tDCS)

Cognitive Training

Intervention Type: BEHAVIORAL

Executive functioning tasks

Interventions

Transcranial Direct Current Stimulation (tDCS)

Participants receive 10 sessions (2 5-visit blocks of 46 minutes) of active tDCS to DLPFC (dorsolateral prefrontal cortex)

Intervention Type: DEVICE

Sham Transcranial Direct Current Stimulation (tDCS)

Participants receive 10 sessions (1 5-visit block of 46 minutes of active tDCS and 1 5-visit block of sham tDCS)

Intervention Type: DEVICE

Cognitive Training

Executive functioning tasks

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelvin Lim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Jazmin Camchong, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1UG3DA048508-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PSYCH-2018-26724

Identifier Type: -

Identifier Source: org_study_id