Clinical Trials

A first-of-its-kind, randomized,  controlled trial with a double-blind study to really measure the efficacy of  tAN to alleviate acute opioid withdrawal symptoms, as well as longer term opioid  withdrawal symptoms over 2-5 days of detox. The study objective is to  measure a clinically significant reduction in opioid withdrawal symptoms, as measured by the Clinical  Opioid Withdrawal Scale (COWS), after 60 minutes of tAN  therapy. This was designed to show the safety and efficacy of the  stimulation and also the durability, day after day. This  study provided evidence to support the initial FDA clearance of the Sparrow  Therapy System, Spark’s first-generation device.

RESTORE is a prospective,randomized, controlled, multi-center, clinical trial aimed at studying the effectsof tAN to reduce rates of relapse, increase treatment retention, reduce opioidwithdrawal symptoms and opioid cravings. Participants are randomized into a 7-dayacute detox phase where they are randomized to receive active or sham tAN incombination with Lofexidine (Lucemyra) or a placebo.  Participants may then randomize into a 3-monthtreatment phase to receive either active tAN plus Naltrexone (Vivitrol) orNaltrexone alone. The study objective is to determine the synergistic effectsof tAN therapy with non-opioid based medications to reduce rates of relapse.