Suvorexant RCT to examine orexin system's role in sleep, stress, and OUD relapse

Opioid Use Disorder (OUD) is characterized by high relapse rates, often exacerbated by sleep disturbances and stress, even for individuals on Medication-Assisted Treatment (MAT). Current MATs effectively reduce cravings and withdrawal but don't fully address the underlying sleep and stress dysregulation that can trigger relapse. The orexin neurotransmitter system is crucial for arousal, sleep-wake cycles, and stress responses, with preclinical data linking it to drug-seeking behaviors. Understanding its role in human OUD could identify novel targets to improve recovery outcomes.

This Phase 2 randomized controlled trial (RCT) will enroll N=200 recently abstinent OUD patients maintained on either extended-release naltrexone (XR-NTX), buprenorphine, or methadone. Participants will be recruited from multiple addiction treatment centers. Within each MAT group, individuals will be randomized to receive either suvorexant or placebo. The study aims to elucidate the orexin system's role in sleep disturbance and circadian rhythms of stress, which may influence relapse behaviors.

This is a study protocol, and no findings are available yet. The study is currently recruiting participants, with an expected start date of May 27, 2025. The primary objective is to investigate how the orexin system contributes to sleep disturbances and stress-related circadian rhythms in OUD patients receiving MAT. Researchers hypothesize that modulating the orexin system with suvorexant will impact these factors, potentially reducing relapse risk. The study anticipates a 20% treatment attrition rate, resulting in N=160 completers. Specific quantitative outcomes or statistical significance values are not yet reported as the trial is ongoing.

The study aims to elucidate the role of the orexin neurotransmitter system in sleep disturbance and circadian rhythms of stress that might in turn influence relapse behaviors.