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

IRB00341328

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.

2022-12-01

2024-11-30

2024-11-30

Recruiting

Early phase I

40

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'The research pharmacy will manage all randomization and blinding.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2023-12-21