Clinical trial NCT03789214: Medical Management of Sleep Disturbance During Opioid Tapering
Official title: Medical Management of Sleep Disturbance During Opioid Tapering
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid Dependence
Opioid Withdrawal
Sleep Disturbance
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-12-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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)

Primary outcomes:
measure: Abuse Liability as Assessed by Visual Analogue Scale
timeFrame: 4 nights
measure: Total Sleep Time During Buprenorphine Taper
timeFrame: Four nights during a buprenorphine taper
measure: Total Sleep Time During Post-taper
timeFrame: Four nights following buprenorphine discontinuation
measure: Subjective Opiate Withdrawal Scale During Buprenorphine Taper
timeFrame: Three days during a buprenorphine taper
measure: Subjective Opiate Withdrawal Scale During Post-taper
timeFrame: Three days following buprenorphine discontinuation
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Andrew S Huhn, PhD
role: PRINCIPAL_INVESTIGATOR
References: