Medical Management of Sleep Disturbance During Opioid Tapering

NCT03789214 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: IRB00198426UG3DA048734
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Dependence; Opioid Withdrawal; Sleep Disturbance

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo sleep medication (Placebo oral capsule)

Drug: Placebo oral capsule

Low Dose Suvorexant

ACTIVE COMPARATOR

Low dose sleep medication

Drug: Low Dose Suvorexant

High Dose Suvorexant

ACTIVE COMPARATOR

High dose sleep medication

Drug: High Dose Suvorexant

Interventions

Placebo oral capsule DRUG

Placebo Sleep Medication

Placebo

Low Dose Suvorexant DRUG

Low Dose Suvorexant

Low Dose Suvorexant

High Dose Suvorexant DRUG

High Dose Suvorexant

High Dose Suvorexant

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-reported male or female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Parasomnias

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Andrew S. Huhn, Ph.D.
• Organization: The Johns Hopkins University School of Medicine

ahuhn1@jhu.edu

410-550-1971

Study Officials

• Andrew S Huhn, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: December 28, 2018
• Study Start: July 1, 2019
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: August 8, 2022
• Results First Posted: August 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)