Clinical trial NCT05546515: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Ages 18-65,
2. Meet criteria for stimulant use disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR)
3. Currently receiving methadone or buprenorphine treatment for OUD and considered to be stable on current dose for at least 30 days
4. Willingness to engage with study protocol
5. Use of birth control (as appropriate)

Exclusion criteria:

1. Psychiatric or medical conditions that are judged by the investigators to interfere with participation or that are contraindicated for use with SUVO
2. Pregnant or breastfeeding
3. Current use of benzodiazepines, tranquilizers, or other schedule IV sleep medications
4. Moderate or severe substance use disorder other than opioid or stimulant use disorder
5. SUVO consumption in the last 30 days
6. Use of medications that are contraindicated with the study
7. Past 30-day suicidal behavior
8. Use of continuous positive airway pressure (CPAP) device for sleep apnea

Primary outcomes:
measure: Opioid use
timeFrame: Up to 30 days post-randomization
measure: Cocaine use
timeFrame: Up to 30 days post-randomization
Secondary outcomes:
measure: Insomnia Severity Index total score
timeFrame: Up to 30 days post-randomization
measure: Total sleep time
timeFrame: Up to 30 days post-randomization
measure: Visual Analog Rating (0-100) of Opioid Craving
timeFrame: Up to 30 days post-randomization
measure: Visual Analog Rating (0-100) of Cocaine Craving
timeFrame: Up to 30 days post-randomization
measure: Perceived Stress Scale Total Score
timeFrame: Up to 30 days post-randomization
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Jennifer Ellis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: