Transcranial Direct Current Stimulation for Opioid use disorder: Protocol for a pilot randomized controlled trial

Abstract

Opioid use disorder (OUD) is a chronic relapsing condition which is characterized by problematic pattern of opioid use despite of physical, mental and social distress. It is important individual and public health problem worldwide, especially in USA due to increased non-medical use of prescription opioids. Medication assisted treatment (MAT) is a gold standard for treatment of OUD which includes pharmacological treatment combined with psychosocial therapies. Though these treatments are effective, there are barriers for successful outcomes. Transcranial direct current stimulation (tDCS) is a safe, simple and effective technique to modulate neuronal excitability. It has been used to reduce craving in substance use disorder (SUD). tDCS may be used in opioid use disorder to reduce craving and drug use. We are proposing pilot, randomized, double blind, placebo-controlled trial protocol to assess effects of anodal tDCS over left dorsolateral prefrontal cortex (DLPFC), in OUD. We will randomize 80 subjects in parallel group design to either active or sham group. Five stimulation sessions of 2 mA for 20 minutes, will be provided. Primary outcome is cue induced craving score on VAS of 0 -10. Measures of feasibility, safety and effectiveness will be assessed at baseline and at different time points over 6 weeks. Aim of this trial is to assess feasibility of tDCS to reduce cue induced craving in OUD and to provide data for future fully powered trials, if trend of effectiveness observed.