Medical Management of Sleep Disturbance During Opioid Tapering
Status:
Completed
Trial end date:
2021-06-10
Target enrollment:
Participant gender:
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.