Phase
Condition
Sleep Disorders
Stimulant Use Disorder
Opioid Use Disorder
Treatment
Placebos
Suvorexant
Clinical Study ID
Ages 21-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Between the ages of 21-65, inclusive.
Past 30-day sleep disturbance as evidenced by a Pittsburgh Sleep Quality Index TotalScore >5.
Enrolled in either outpatient methadone-maintenance, buprenorphine-maintenance, orXR-NTX treatment for OUD.
Willingness to be maintained on a protocolized dose starting between 60-130mgmethadone or 380mg XR-NTX for the duration of the study.
At least two weeks of continuous abstinence from illicit opioids as evidenced byself-report and urine drug screens collected as part of routine care.
Willing to comply with the study protocol, which will include weekly study visits,daily actigraphy and ecological momentary assessments.
Use of birth control throughout study.
Have no clinically significant chronic medical disorders or conditions that arejudged by the investigators to prevent participation.
Exclusion
Exclusion Criteria:
Serious mental illnesses that are unstable and could affect study participation (thought disorders, hallucinations, delusions, thoughts of harm to self/others).
Current moderate to severe substance use disorder other than OUD.
Current illicit stimulant use, including cocaine and methamphetamine.
Pregnant or breast feeding.
Have a known allergy to the study medications.
Past 30-day prescribed use of suvorexant.
Current use of a benzodiazepine or other schedule IV medication for insomnia.
Use of Cytochrome P450 3A inhibitors.
Current narcolepsy, sleep paralysis, or restless leg syndrome as assessed by medicalhistory
Apnea-hypopnea index > 30.
Use of glucocorticoid medications and any medication that would alter thehypothalamic-pituitary-adrenal axis.
Past 30-day suicidal behavior as assessed by the Columbia Suicide Severity RatingScale (C-SSRS).
Have circumstances that would interfere with study participation (e.g., impendingjail; severe clinical issues).
Study Design
Connect with a study center
Addiction Treatment Services at Johns Hopkins Bayview Medical Center
Baltimore, Maryland 21224
United StatesActive - Recruiting
Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center
Baltimore, Maryland 21224
United StatesActive - Recruiting
Man Alive Inc., Lane Treatment Center
Baltimore, Maryland 21218
United StatesActive - Recruiting
Ashley Addiction Treatment
Bel Air, Maryland 21014
United StatesActive - Recruiting
Ashley Addiction Treatment
Elkton, Maryland 21921
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.