At a glance
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Medical Management of Sleep Disturbance During Opioid Tapering
In Brief
A Phase 2 clinical trial evaluating Placebo oral capsule, Low Dose Suvorexant, and 1 other intervention for Opioid Dependence and 2 related conditions. Completed, enrolled 90 participants across 1 site.
Detailed Summary
This study will evaluate whether a dual orexin-receptor antagonist approved by the FDA for sleep disturbance, suvorexant (SUVO; Belsomra), will increase total sleep time in patients with opioid use disorder (OUD) undergoing supervised withdrawal. This study is designed as a dose-finding study of SUVO compared to placebo. Briefly, OUD patients seeking supervised withdrawal will be admitted into a clinical research unit and stabilized onto buprenorphine for three days before being randomly assigned to study condition. All participants will then undergo a routine four-day buprenorphine taper, followed by a four-day post-taper phase. Participants will be randomized to receive either placebo, Low Dose SUVO, or High Dose SUVO and the investigators hypothesize that one or both doses of SUVO will improve total sleep time relative to placebo. Patients will attend a single follow-up session, 5-10 days following discharge.
Study Details
Timeline
Interventions
Placebo Sleep Medication
Low Dose Suvorexant
High Dose Suvorexant