NCT03789214

Medical Management of Sleep Disturbance During Opioid Tapering

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Dependence
• Opioid Withdrawal
• Sleep Disturbance

Interventions

Type	Name	Description
DRUG	Placebo oral capsule	Placebo Sleep Medication
DRUG	Low Dose Suvorexant	Low Dose Suvorexant
DRUG	High Dose Suvorexant	High Dose Suvorexant

Timeline

• Start date: 2019-07-01
• Primary completion: 2021-06-10
• Completion: 2021-06-10
• First posted: 2018-12-28
• Last updated: 2022-08-08
• Results posted: 2022-08-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study