Phase 2 N=38 Randomized Quadruple-blind Treatment

Medical Management of Sleep Disturbance During Opioid Tapering

Opioid Dependence · Opioid Withdrawal · Sleep Disturbance

Bottom Line

View on ClinicalTrials.gov: NCT03789214 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2022

Primary outcome: Primary: Abuse Liability as Assessed by Visual Analogue Scale — 23.9; 20.9; 22.8 score on a scale*days — p=.950

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo oral capsule (Drug); Low Dose Suvorexant (Drug); High Dose Suvorexant (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Jun 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Abuse Liability as Assessed by Visual Analogue Scale	23.9; 20.9; 22.8	.950
PRIMARY Total Sleep Time During Buprenorphine Taper	891.6; 1183.6; 1098.4	.048 sig
PRIMARY Total Sleep Time During Post-taper	1049.3; 1113.2; 1055.9	.691
PRIMARY Subjective Opiate Withdrawal Scale During Buprenorphine Taper	15.5; 10.8; 14.8	.620
PRIMARY Subjective Opiate Withdrawal Scale During Post-taper	17.9; 9.0; 6.4	.067

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.

Eligibility Criteria

Inclusion Criteria

Aged 18 years old and above
Meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for OUD with evidence of physical dependence on opioids, and seeking treatment to stop using illicit opioids.
Provides a urine sample that tests positive for opioids.
Willing to comply with the study protocol.
Have no clinically significant chronic medical or surgical disorders or conditions that are judged by the investigators to prevent participation.

Exclusion Criteria

Seeking or currently enrolled in methadone or buprenorphine maintenance treatment for OUD
Pregnant or breast feeding
Have evidence of physical dependence on alcohol or benzodiazepines that requires medical detoxification
Have a known allergy to the study medications
Past 30-day prescribed use of suvorexant or benzodiazepines for the indication of insomnia
Current use of a Selective Serotonin Reuptake Inhibitor (SSRI) or Monoamine oxidase (MAO) inhibitor for depression or insomnia, or other medications that are contraindicated with suvorexant
Current narcolepsy, restless leg syndrome or sleep paralysis
High risk for current sleep apnea
Current major depressive disorder
Past year suicidal behavior
Severe hepatic or renal impairment
Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >3x ULN
Total bilirubin >2x Upper Limit of Normal (ULN)
Creatinine >1.5x ULN
Have circumstances that would interfere with study participation (e.g., impending jail)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03789214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.