Abstract
BACKGROUND: Opioid use disorder (OUD) is a devastating condition with frequent suicidality, contributing to overdose deaths. Theta burst stimulation (TBS) to the dorsolateral prefrontal cortex (DLPFC) is used to treat major depressive disorder (MDD) and is effective in treating suicidal ideation. We piloted a randomized, double-blind, sham-controlled trial of bilateral rTMS for patients with OUD and MDD experiencing suicidality. METHODS: Sequential bilateral TBS was delivered guided by structural neuroimaging: continuous TBS to the right then intermittent TBS to the left DLPFC, daily (20 treatments). The primary objective was to determine the feasibility of this population. The primary clinical outcome was the scale for suicidal ideation (SSI), secondary outcomes included depressive symptoms and opioid cue-induced craving. ClinicalTrials.gov: NCT04785456. RESULTS: Eighty-seven individuals were pre-screened. The most common reasons for ineligibility included being unreachable by the study team, difficulty with scheduling/travel requirements, and medical/psychiatric instability. Six participants (5:1 M:F) were enrolled (3/arm), four had a fentanyl use history; two completed per protocol (1/arm). Of the participants with follow-up data, SSI scores decreased in 2/3 in the sham arm and 2/2 in the active arm; depression and opioid craving scores decreased in all participants. CONCLUSION: We present the first data piloting a structural neuroimaging-guided, multi-session rTMS treatment course in outpatients with suicidality and OUD in the current North American context. Recruitment and retention were the main challenges given the highly unstable medical and psychosocial context of this patient population. Future trials should consider a suitable environment to improve the feasibility of delivering this treatment.