Suvorexant for Opioid/Stimulant Co-use
Primary Purpose
Opioid Use Disorder, Stimulant Use Disorder
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Suvorexant (dual orexin receptor antagonist)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Use Disorder focused on measuring Orexin receptor antagonist, Suvorexant, Cocaine, Opioid, Opiate, Heroin, Fentanyl, Nonmedical opioid use, Methadone, Buprenorphine, Suboxone, Polysubstance use, Co-use, Substance-related disorders, Narcotic-related disorders, Chemically-induced disorders, Sleep, Stress, Opioid-related disorders, Stimulant-related disorders, Cocaine use disorder
Eligibility Criteria
Inclusion Criteria:
- Ages 18-65,
- Meet criteria for stimulant use disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR)
- Currently receiving methadone or buprenorphine treatment for OUD and considered to be stable on current dose for at least 30 days
- Willingness to engage with study protocol
- Use of birth control (as appropriate)
Exclusion criteria:
- Psychiatric or medical conditions that are judged by the investigators to interfere with participation or that are contraindicated for use with SUVO
- Pregnant or breastfeeding
- Current use of benzodiazepines, tranquilizers, or other schedule IV sleep medications
- Moderate or severe substance use disorder other than opioid or stimulant use disorder
- SUVO consumption in the last 30 days
- Use of medications that are contraindicated with the study
- Past 30-day suicidal behavior
- Use of continuous positive airway pressure (CPAP) device for sleep apnea
Sites / Locations
- Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Suvorexant
Placebo
Arm Description
20mg Suvorexant
Placebo oral capsules
Outcomes
Primary Outcome Measures
Opioid use
Opioid use (measured via uranalysis for qualitative opioid assay) other than prescribed methadone or buprenorphine at scheduled study visits up to 30 days post-randomization (yes vs. no)
Cocaine use
Cocaine use (measured via uranalysis for qualitative cocaine assay) at scheduled study visits up to 30 days post-randomization.
Secondary Outcome Measures
Insomnia Severity Index total score
Insomnia severity index total scores at scheduled study visits up to 30 days post-randomization.
Total sleep time
Minutes of total sleep time at scheduled study visits up to 30 days post-randomization.
Visual Analog Rating (0-100) of Opioid Craving
Opioid craving, as measured via an average score on visual analog scales (VAS), at scheduled study visits up to 30 days post-randomization.
Visual Analog Rating (0-100) of Cocaine Craving
Cocaine craving, as measured via an average score on visual analog scales (VAS), collected at scheduled study visits up to 30 days post-randomization.
Perceived Stress Scale Total Score
Perceived stress, measured by the Perceived Stress Scale total score at scheduled study visits up to 30 days post-randomization.
Full Information
NCT ID
NCT05546515
First Posted
September 14, 2022
Last Updated
December 13, 2022
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT05546515
Brief Title
Suvorexant for Opioid/Stimulant Co-use
Official Title
Safety and Efficacy of Suvorexant for Opioid/Stimulant Co-use Among Individuals in Treatment for Opioid Use Disorder (OUD)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate whether Suvorexant 20mg reduces drug use and craving, and improves sleep and stress among persons with co-occurring opioid use disorder and stimulant use disorder.
Detailed Description
This between-subjects, double-blinded, randomized controlled pilot study will recruit patients who are receiving methadone or buprenorphine treatment for OUD and are using cocaine. Participants will be randomly assigned to receive up to 30-days of Suvorexant (SUVO) or placebo. They will visit the clinic regularly to provide urine drug screens and complete questionnaires and will wear a device that can measure their sleep parameters. We expect that relative to persons who receive placebo, individuals who receive SUVO will 1) be less likely to screen positive for cocaine and/or opioids on urine drug screens, 2) will report lower drug craving, 3) will have longer total sleep time, 4) will report fewer insomnia symptoms, and 5) will report overall lower stress than persons who receive placebo. We also expect that patients will not have side effects from SUVO. These preliminary data will inform whether this FDA-approved medication may help patients stop co-using opioids and stimulants, which can be scaled up to reduce public health consequences related to co-use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, Stimulant Use Disorder
Keywords
Orexin receptor antagonist, Suvorexant, Cocaine, Opioid, Opiate, Heroin, Fentanyl, Nonmedical opioid use, Methadone, Buprenorphine, Suboxone, Polysubstance use, Co-use, Substance-related disorders, Narcotic-related disorders, Chemically-induced disorders, Sleep, Stress, Opioid-related disorders, Stimulant-related disorders, Cocaine use disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The research pharmacy will manage all randomization and blinding.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Suvorexant
Arm Type
Active Comparator
Arm Description
20mg Suvorexant
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oral capsules
Intervention Type
Drug
Intervention Name(s)
Suvorexant (dual orexin receptor antagonist)
Intervention Description
Participants will be prescribed up to 30 days of SUVO.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will be prescribed up to 30 days of placebo medication.
Primary Outcome Measure Information:
Title
Opioid use
Description
Opioid use (measured via uranalysis for qualitative opioid assay) other than prescribed methadone or buprenorphine at scheduled study visits up to 30 days post-randomization (yes vs. no)
Time Frame
Up to 30 days post-randomization
Title
Cocaine use
Description
Cocaine use (measured via uranalysis for qualitative cocaine assay) at scheduled study visits up to 30 days post-randomization.
Time Frame
Up to 30 days post-randomization
Secondary Outcome Measure Information:
Title
Insomnia Severity Index total score
Description
Insomnia severity index total scores at scheduled study visits up to 30 days post-randomization.
Time Frame
Up to 30 days post-randomization
Title
Total sleep time
Description
Minutes of total sleep time at scheduled study visits up to 30 days post-randomization.
Time Frame
Up to 30 days post-randomization
Title
Visual Analog Rating (0-100) of Opioid Craving
Description
Opioid craving, as measured via an average score on visual analog scales (VAS), at scheduled study visits up to 30 days post-randomization.
Time Frame
Up to 30 days post-randomization
Title
Visual Analog Rating (0-100) of Cocaine Craving
Description
Cocaine craving, as measured via an average score on visual analog scales (VAS), collected at scheduled study visits up to 30 days post-randomization.
Time Frame
Up to 30 days post-randomization
Title
Perceived Stress Scale Total Score
Description
Perceived stress, measured by the Perceived Stress Scale total score at scheduled study visits up to 30 days post-randomization.
Time Frame
Up to 30 days post-randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages 18-65,
Meet criteria for stimulant use disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR)
Currently receiving methadone or buprenorphine treatment for OUD and considered to be stable on current dose for at least 30 days
Willingness to engage with study protocol
Use of birth control (as appropriate)
Exclusion criteria:
Psychiatric or medical conditions that are judged by the investigators to interfere with participation or that are contraindicated for use with SUVO
Pregnant or breastfeeding
Current use of benzodiazepines, tranquilizers, or other schedule IV sleep medications
Moderate or severe substance use disorder other than opioid or stimulant use disorder
SUVO consumption in the last 30 days
Use of medications that are contraindicated with the study
Past 30-day suicidal behavior
Use of continuous positive airway pressure (CPAP) device for sleep apnea
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly E Dunn, Ph.D, M.B.A.
Phone
410-550-2254
Email
kdunn9@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly E Dunn, Ph.D, M.B.A.
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly E Dunn, Ph.D, M.B.A.
Phone
410-550-2254
Email
kdunn9@jhmi.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Suvorexant for Opioid/Stimulant Co-use
We'll reach out to this number within 24 hrs