Medical Management of Sleep Disturbance During Opioid Tapering

Sleep Disturbance Clinical Trial

Official title:

Medical Management of Sleep Disturbance During Opioid Tapering

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03789214
• Other study ID #: IRB00198426
• Secondary ID: UG3DA048734
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2019
• Est. completion date: June 10, 2021

Study information

• Verified date: July 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 10, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dyssomnias
• Opioid Dependence
• Opioid Withdrawal
• Opioid-Related Disorders
• Parasomnias
• Sleep Disturbance

Intervention

Drug:
• Placebo oral capsule
Placebo Sleep Medication
• Low Dose Suvorexant
Low Dose Suvorexant
• High Dose Suvorexant
High Dose Suvorexant

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abuse Liability as Assessed by Visual Analogue Scale	Area-under-the-curve of self-reported feelings of drug "High" on the morning after study drug administration, measured each morning on a 0-100 point visual analogue scale of the question "Last night, did you feel HIGH?". A score of "0" indicates no abuse liability and a score of 100 indicates extreme abuse liability. This will be assessed over four nights during an opioid taper.	4 nights
Primary	Total Sleep Time During Buprenorphine Taper	Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.	Four nights during a buprenorphine taper
Primary	Total Sleep Time During Post-taper	Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.	Four nights following buprenorphine discontinuation
Primary	Subjective Opiate Withdrawal Scale During Buprenorphine Taper	Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).	Three days during a buprenorphine taper
Primary	Subjective Opiate Withdrawal Scale During Post-taper	Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).	Three days following buprenorphine discontinuation