Transcranial Direct Current Stimulation to Modulate Top-Down Regulation for Drug Craving in Methamphetamine Use Disorder
Condition: Amphetamine Use Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed description: 
      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. The
      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. The investigators hypothesize that tDCS amplifies DLPFC's top-down modulatory role
      via its connectivity to other cortical-subcortical areas. In this double blind randomized
      experimental design, the investigators will recruit 60 people with MUD during their early
      abstinence phases into parallel arms with active and sham DLPFC tDCS. Each subject will
      undergo resting state and task based (drug cue exposure paradigm) functional MRI pre and post
      tDCS. The investigators will conduct individual difference analyses to explore the potential
      predictors for tDCS response, including pre-tDCS top-down connectivity measures of DLPFC and
      other subjective, clinical, behavioral, structural, and functional variables. The results of
      this study will provide neuroscience-based evidence for the efficacy of tDCS and will advance
      the field towards precision addiction medicine.
    

Intervention name(s): Active transcranial Direct Current Stimulation (tDCS); Sham transcranial Direct Current Stimulation (tDCS)
Intervention type(s): Device; Device
Intervention description(s): 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.; 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: methamphetamine; transcranial Direct Current Stimulation; functional Magnetic Resonance Imaging; amphetamine; drug craving