Suvorexant for Opioid/Stimulant Co-use

Sponsor

Johns Hopkins University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05546515

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Disorder Stimulant Use Disorder	Drug: Suvorexant (dual orexin receptor antagonist) Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The research pharmacy will manage all randomization and blinding.

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy of Suvorexant for Opioid/Stimulant Co-use Among Individuals in Treatment for Opioid Use Disorder (OUD)

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Suvorexant 20mg Suvorexant	Drug: Suvorexant (dual orexin receptor antagonist) Participants will be prescribed up to 30 days of SUVO.
Placebo Comparator: Placebo Placebo oral capsules	Drug: Placebo Participants will be prescribed up to 30 days of placebo medication.

Arm

Intervention/Treatment

Active Comparator: Suvorexant

20mg Suvorexant

Drug: Suvorexant (dual orexin receptor antagonist)

Participants will be prescribed up to 30 days of SUVO.

Placebo Comparator: Placebo

Placebo oral capsules

Drug: Placebo

Participants will be prescribed up to 30 days of placebo medication.

Outcome Measures

Primary Outcome Measures

Opioid use [Up to 30 days post-randomization]
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 [Up to 30 days post-randomization]
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 [Up to 30 days post-randomization]
Insomnia severity index total scores at scheduled study visits up to 30 days post-randomization.
Total sleep time [Up to 30 days post-randomization]
Minutes of total sleep time at scheduled study visits up to 30 days post-randomization.
Visual Analog Rating (0-100) of Opioid Craving [Up to 30 days post-randomization]
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 [Up to 30 days post-randomization]
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 [Up to 30 days post-randomization]
Perceived stress, measured by the Perceived Stress Scale total score at scheduled study visits up to 30 days post-randomization.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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