Transcranial Direct Current Stimulation to Modulate Top-Down Regulation for Drug Craving in Methamphetamine Use Disorder

NCT03382379 | Completed Phase 1

• 1 other identifier: 2017-005-00
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Methamphetamine use disorder (MUD) is among the costliest and deadliest substance use disorders (SUDs) world-wide and is frequently comorbid with other mental health conditions. There is no empirically validated medical treatment for MUD. Drug craving is the signature aspect of MUD and other substance use disorders and has been associated with continued drug use and relapse. The investigators and others have shown that transcranial direct current stimulation (tDCS) over dorsolateral prefrontal cortex (DLPFC) can modulate drug craving in different SUDs. tDCS is a method of non-invasive brain stimulation and is a low-cost scalable technology without any serious side effects that delivers low levels of direct current (0.1-2 mAmp) transcranially. However, there are significant inter-individual differences in response to tDCS, which is not well understood but can have profound impact on efficacy. Meanwhile, there are no studies with neuroimaging to show how tDCS affects drug craving. Investigators propose the first combined tDCS/functional Magnetic Resonance Imaging (fMRI) study to examine the acute effects of tDCS on neural substrates underlying drug induced craving.

Conditions

Amphetamine Use Disorders

Keywords

methamphetamine; transcranial Direct Current Stimulation; functional Magnetic Resonance Imaging; amphetamine; drug craving

Outcome Measures

Primary Outcomes (2)

• Change in Drug Cue Reactivity BOLD Signal in fMRI from before to after Intervention

  Drug Cue Reactivity BOLD Signal is measured as average blood oxygen level dependent (BOLD) signal difference with voxel-wise analysis in the regions of interests (ROIs) (prefrontal cortex parcels, insula segments, striatum nuclei, thalamus nuclei and extended amygdala nuclei) in craving \> neutral contrast in drug cue exposure fMRI task with blocks of neutral and drug related images

  Immediate before and immediate after intervention

• Change in Drug Cue Reactivity Self-Report from before to after Intervention

  Drug cue reactivity self-report is measured as the difference in subjective response to "On a scale of 0-100, How much drug craving are you experiencing RIGHT NOW" measured on a visual analog scale (0-100) before and after drug cue exposure fMRI task

  Immediate before and immediate after intervention

Secondary Outcomes (6)

• Change in Cortical-Subcortical Connectivity in Resting State fMRI from before to after Intervention

  Immediate before and immediate after intervention

• Change in Cortical-Subcortical Task-based Connectivity in Cue Exposure fMRI from before to after Intervention

  Immediate before and immediate after intervention

• Change in RAI in Resting State fMRI from before to after Intervention

  Immediate before and immediate after intervention

• Change in Area Under Electrode Connectivity in Resting State fMRI from before to after Intervention

  Immediate before and immediate after intervention

• Change in Area Under Electrode Task-based Connectivity in Cue Exposure fMRI from before to after Intervention

  Immediate before and immediate after intervention

Other Outcomes (4)

• Change in Drug Cue Control Response from before to after Intervention

  Immediate before and immediate after intervention

• Change in DI DDQ Score from before to after Intervention

  Immediate before and immediate after intervention

• Change in NR DDQ Score from before to after Intervention

  Immediate before and immediate after intervention

Study Arms (2)

Active

EXPERIMENTAL

Participants in the active arm will receive 2 milliamp anodal transcranial Direct Current Stimulation (tDCS) over the Dorso-Lateral Pre-Frontal Cortex (DLPFC).

Device: Active transcranial Direct Current Stimulation (tDCS)

Sham

PLACEBO COMPARATOR

Participants in the Sham arm will receive sham transcranial Direct Current Stimulation (tDCS) over the Dorso-Lateral Pre-Frontal Cortex (DLPFC).

Device: Sham transcranial Direct Current Stimulation (tDCS)

Interventions

Active transcranial Direct Current Stimulation (tDCS) DEVICE

Transcranial Direct Current Stimulation (tDCS) as a device-based technology is employed by applying a very weak (2 mAmp) direct current over the skull for 1200 seconds with 30 seconds ramp up to 2 mAmp, and 30 seconds ramp down at the end.

Active

Sham transcranial Direct Current Stimulation (tDCS) DEVICE

Sham Transcranial Direct Current Stimulation (tDCS) as a device-based technology is employed by applying a very weak direct current over the skull. Sham mode will have just 30 seconds ramp up to 2 mAmp, 40 seconds on 2 mAmp stimulation and, 30 seconds ramp down with 1160 seconds no stimulation (just impedance control).

Sham

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• English speaking.
• Diagnosed with Methamphetamine Use Disorder (last 12 months) based on the Mini International Neuropsychiatric Interview (MINI) interview (Diagnostic and Statistical Manual of Mental Disorders-DSM-5)
• Being abstinent from methamphetamine in an addiction treatment program for at least one week based on medical records or self-report
• Positive response to Methamphetamine cue-reactivity screening (MCS)
• 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 methamphetamine 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 (PCP), 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 tDCS stimulation based on the fMRI safety and tDCS 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

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

Study Officials

• Hamed Ekhtiari, MD, PhD

  Laureate Institute for Brain Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 22, 2017
• Study Start: November 30, 2017
• Primary Completion: February 10, 2019
• Study Completion: February 10, 2019
• Last Updated: June 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)