Status:
COMPLETED
Medical Management of Sleep Disturbance During Opioid Tapering
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Dependence
Opioid Withdrawal
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 di...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03789214
Start Date
July 1 2019
End Date
June 10 2021
Last Update
August 8 2022
Active Locations (1)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224