NCT04262193|TerminatedPhase 2DMCFDA Drug
Study Stopped
Did not meet enrollment goals.
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Did not meet enrollment goals.
Sponsor study identifier
interventional
37
1 country
1
Study Start
February 1, 2021
Actual (reported)Primary Completion
July 30, 2024
Actual (reported)Study Completion
July 30, 2024
Actual (reported)Summary of Study Protocol. This project is designed to test neurobehavioral mechanisms underlying effects of the dual orexin-1/2 receptor antagonist suvorexant on sleep efficiency and opioid abstinence, and whether these outcomes are independent of one another. This will be the first study to investigate whether suvorexant improves outpatient opioid abstinence and sleep efficiency; and whether improving sleep mediates the improved opioid abstinence outcome. 120 participants with opioid use disorder (OUD) will complete this intent-to-treat study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 30, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 6, 2020
Actual (reported)February 10, 2020
Actual (reported)February 1, 2021
Actual (reported)July 30, 2024
Actual (reported)July 30, 2024
Actual (reported)Opioid abstinence
Percentage of opioid-free urine drug screens (UDS)
up to 13 weeks
Sleep efficiency
Sleep efficiency equals sleep time (determined by standardized scoring of electroencephalogram recordings) divided by time in bed
Sleep efficiency is measured on the evening of the first medication dose
Daily sleep questionnaire
Change in sleep quality scores from inpatient stay to outpatient weeks 2, 6 and 10
Actigraphic assessment of sleep
Change in total activity counts across outpatient weeks 2, 6 and 10
Weekly sleep questionnaire
Change in sleep quality scores across outpatient weeks 1, 4, 8 and 12
Timeline followback interview assessment of substance use
Once weekly (in conjunction with urine drug screen) on outpatient weeks 1 through 13
Urinary cortisol
Measured at 11pm on nights 4, 6, 8 (coordinated with sleep efficiency and melatonin assessments) and the following day (7am and 3pm on days 5, 7, 9) on the inpatient unit
Placebo (inert) tablet
Suvorexant 20mg tablet
In each group, the participant will take 1 tablet (placebo or 20mg) 30 minutes before bedtime.
Suvorexant Placebo
Wayne State University
Detroit, Michigan, 48202, United States
Mark K Greenwald, PhD
Wayne State University
37 participants (actual enrollment reported by the registry).
First Submitted
February 6, 2020
First Posted
February 10, 2020
Medication Development in Alcoholism: Suvorexant Versus Placebo
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Start
February 1, 2021
Actual (reported)Primary Completion
July 30, 2024
Actual (reported)Study Completion
July 30, 2024
Actual (reported)Last Updated
September 25, 2024
Record last verified: 2024-09
This plan is under development. This project was funded under the NIH HEAL Initiative, which requires data sharing through a repository; IPD details are being determined.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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