Frontoparietal Synchronization to Modulate Drug Craving in Opioid Use Disorder

Completed · Not applicable · Has a placebo group

Conditions studied: Opioid-use Disorder

In brief

Opioid use disorder (OUD) is among the costliest and deadliest substance use disorders (SUDs) in the US and world-wide. Opioids were involved in 42,249 deaths in the US in 2016, which were more than deaths due to road accidents and gun violence combined. Opioid overdose deaths were five times higher in 2016 than 1999. Meanwhile, the treatment options for OUD are limited and long-term efficacy is poor. There is a hope that recent advances in understanding of the cognitive neuroscience underlying addictive behavior, like drug craving and its regulatory processes, can bring new opportunities for more effective and personalized treatment options for OUD. Drug craving is the signature aspect of OUD as well as other SUDs which has been associated with continued drug use and relapse. In previous studies, the investigators have shown significant response to drug related cues in both frontoparietal and limbic areas including amygdala and ventral striatum. In a recent pilot study, the investigators showed significant lower connectivity between amygdala and frontoparietal areas, including dorsolateral prefrontal cortex (DLPFC) and inferior parietal cortex (IPC), major nodes of the executive control network (ECN), in patients with OUD compared with healthy controls. The central role of the ECN is to perform top down regulation of subcortical limbic areas during self-control, emotion-regulation, and response- inhibition tasks. These processes are well known to be affected in different psychopathologies including SUDs. There is a growing body of evidence that external frontoparietal synchronization (FPS) with transcranial alternating current stimulation (tACS) can potentially modulate connectivity within ECN and between ECN and limbic areas. This may improve some aspects of executive function and top down regulation. tACS is a low-cost and scalable non-invasive brain stimulation technology without any serious side effects. The procedure involves the transcranial delivery of low levels of alternating current (0.1-2 mAmp) in different frequencies through the skull into the brain with both online and long-term offline effects. This trial is the first combined tACS/fMRI study to examine the acute offline effects of FPS on neural substrates underlying drug induced craving. We hypothesize that FPS amplifies the ECN top-down modulatory role via its connectivity to other cortical-subcortical areas. In this experimental design, the investigators will recruit 60 people with OUD during the early abstinence phase in a residential setting divided into two parallel arms with active and sham FPS tACS. Each subject will undergo resting state and task based (drug cue exposure paradigm) functional MRI pre and post FPS. The investigators will also conduct individual difference analyses to explore the potential predictors for FPS response, including pre-FPS top-down connectivity measures of ECN and other subjective, clinical, behavioral, structural, and functional variables. The results of this study will provide mechanistic neuroscience-based evidence for the efficacy of FPS and will advance the field towards precision addiction medicine.

Key facts

Study ID: NCT03907644
Run by: Laureate Institute for Brain Research, Inc.
People needed: 60
Starts: 2019-03-15
Expected to finish: 2023-06-15
Last updated by the study team: 2023-07-11

Who can join

Age: 18 and older, up to 61. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Male
Age ≥18 and <61 years old
English speaking
Diagnosed with Opioid Use Disorder (last 12 months) based on the structured interview (DSM V)
Being abstinent from opioid in an addiction treatment program for at least 3 days based on medical records or self-report
Positive response to Opioid cue-reactivity screening (OCS)
Willing and capable of interacting with the informed consent process

You may not qualify if…

Unwillingness or inability to complete any of the major aspects of the study protocol, including magnetic resonance imaging (i.e., due to claustrophobia), drug cue rating, or behavioral assessment.
Abstinence from opioid for more than 6 months based on self-report
Schizophrenia or bipolar disorder based on the MINI interview
Active suicidal ideation with intent or plan determined by self-report or assessment by PI or study staff during the initial screening or any other phase of the study
Positive drug test for amphetamines, opioids, cannabis, alcohol, phencyclidine, or cocaine confirmed by breath analyzer and urine tests
Any active skin disorder that affects skin integrity of the scalp
Having any condition that would preclude undergoing an fMRI scan or FPS (tACS) stimulation based on the fMRI safety and transcranial electrical stimulation safety checklists
Unstable medical disorder reported in subject's medical history or by a clinician assessment
History of seizure
Non-correctable vision or hearing problems.
Any other condition the PI or study staff feel would put the subject at risk for entering the study

Where it is running

Laureate Institute for Brain Research — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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