Dual-Orexin Antagonism as a Mechanism for Improving Sleep and Drug Abstinence in Opioid Use Disorder

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Summary of Study Protocol. This project is designed to test neurobehavioral mechanisms underlying effects of the dual orexin-1/2 receptor antagonist suvorexant on sleep efficiency and opioid abstinence, and whether these outcomes are independent of one another. This will be the first study to investigate whether suvorexant improves outpatient opioid abstinence and sleep efficiency; and whether improving sleep mediates the improved opioid abstinence outcome. 180 participants with opioid use disorder (OUD) who have just completed detoxification will complete this intent-to-treat study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wayne State University
• Collaborator: Henry Ford Health System
• Treatments: Suvorexant

Criteria

Inclusion Criteria:

• Age 18-70 years old

• Males and non-pregnant females who agree to medically accepted birth control for the duration of the study

• Meet DSM-5 criteria for opioid use disorder (any severity level) alone or comorbid with stable medical diseases (except for certain medications [see below])

• Must complete opioid detoxification (days 1-4 on the inpatient unit)

Exclusion Criteria:

• Body mass index >38

• Acute/unstable illness: conditions making it unsafe for participation, conditions with potential to disturb sleep (i.e. acute pain, respiratory infection)

• Chronic illnesses; renal failure, liver disease, seizures, and dementing illnesses

• Current psychiatric disease: psychosis, bipolar disorder, PTSD

• Smoking during the night (11pm-7am). Nicotine replacement therapy is allowed

• Medications including anxiolytics, hypnotics (both prescription and OTC), sedating antidepressants, anticonvulsants, sedating H1 antihistamines (non-sedating second generation H4 antihistamines are allowed), systemic steroids, respiratory stimulants and decongestants, prescription and OTC stimulants, prescription and OTC diet aids, herbal preparations, and narcotic analgesics. All medications and doses will be documented

• Sleep-disordered breathing and periodic leg movements (PLMs) defined as ≥ 10 apnea-hypopneas or PLM events related to EEG arousal per hour of sleep time, or any other primary sleep (e.g. narcolepsy, restless legs syndrome) or circadian disorder

• Night-shift work, which would alter circadian rhythm and be a confound in this trial.