This study is designed to elucidate the role of the orexin neurotransmitter system in sleep disturbance and circadian rhythms of stress that might in turn influence relapse behaviors in persons on medication-assisted treatments (MAT) who are in early recovery from opioid use disorder (OUD). Briefly, the study will enroll recently abstinent OUD patients (N=200) maintained on either extended-release naltrexone (XR-NTX), buprenorphine, or methadone. Within each MAT group, participants will be randomized to either suvorexant or placebo. The study is expected to have a 20% treatment attrition rate which will result in N=160 completers in the entire study. Patients will be recruited from and treated at Ashley Addiction Treatment, Addiction Treatment Services at Johns Hopkins Bayview Medical Center, Man Alive, or community providers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
138
Dual orexin receptor antagonist
Weight and color matched placebo
Man Alive Inc., Lane Treatment Center
Baltimore, Maryland, United States
Addiction Treatment Services at Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Ashley Addiction Treatment
Bel Air, Maryland, United States
Ashley Addiction Treatment
Elkton, Maryland, United States
Total Sleep Time
Mean total number of minutes slept per night as measured by actigraphy and self-reported sleep diary. Mean total sleep time will be collected over a seven-night period in weeks 1, 4, and 8 of the trial.
Time frame: 21 nights
Total Wake Time After Sleep Onset
Mean total number of minutes awake between initial sleep onset and final morning awakening, measured by actigraphy and self-reported sleep diary. Mean wake after sleep onset will be collected over a seven-night period in weeks 1, 4, and 8 of the trial.
Time frame: 21 nights
Change in Perceived Stress Scale 4 (PSS-4) score
Mean daily scores on the PSS-4 (a four item scale self-reported scale than measures stress using a 0-4 Likert scale; total range of PSS-4 scores is 0-16; lower scores indicate lower daily stress relative to higher scores, which indicate higher daily stress). Mean PSS-4 scores will be collected over a seven-day period in weeks 1, 4, and 8 of the trial.
Time frame: 21 days (collected over a seven-day period in weeks 1, 4, and 8 of the trial)
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