Dual-Orexin Antagonism as a Mechanism for Improving Sleep and Drug Abstinence in Opioid Use Disorder

Summary

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Description

Study Design. Using a placebo-controlled, parallel-group, randomized clinical trial design, we will prospectively evaluate whether nightly treatment with the orexin-1/2 receptor antagonist suvorexant (10 or 20 mg/day PO), relative to placebo, can increase outpatient opioid abstinence and improve sle...

Study Design. Using a placebo-controlled, parallel-group, randomized clinical trial design, we will prospectively evaluate whether nightly treatment with the orexin-1/2 receptor antagonist suvorexant (10 or 20 mg/day PO), relative to placebo, can increase outpatient opioid abstinence and improve sleep efficiency (sleep time per time-in-bed) as a mediator/moderator among patients with OUD. We have included current major depression and current alcohol use disorder severity as stratification factors in the group allocation. Using power and sample size calculations, we estimate that 60 participants in each study arm will suffice to test our hypotheses. We anticipate enrolling 210 participants to obtain the 180 completers (60 participants in each of the 3 treatment arms). The study aims to test three co-primary hypotheses: Hypothesis 1: Relative to placebo, at least one of the two suvorexant doses (10 or 20 mg/day) will significantly increase percentage opioid abstinence during outpatient weeks 1-13. Hypothesis 2: Relative to placebo (i.e. expected sleep loss related to opioid detoxification), at least one of the two suvorexant doses will improve sleep efficiency during the inpatient stay. Hypothesis 3: Higher inpatient sleep efficiency will be associated with increased outpatient opioid abstinence (independent of experimental group assignment).

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