Phase 2 Sleep Disorders Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years of age or older
• You have been diagnosed with opioid use disorder (OUD) of at least moderate severity, based on current diagnostic guidelines
• You are currently receiving outpatient treatment for OUD using buprenorphine, either as a dissolvable film or tablet (between 8mg and 24mg) or as a monthly injectable form
• You have been on your current buprenorphine dose for at least 4 weeks and there are no plans to change your dose in the next 3 months
• A urine test at screening shows buprenorphine is present at appropriate levels, as confirmed by a study doctor
• A urine test at screening shows no other non-prescribed substances (marijuana/cannabis is allowed), and a breath or saliva alcohol test is negative
• You screen positive for long-term sleep problems (chronic insomnia) based on a specific sleep questionnaire used in the study
• Your insomnia symptom score is 13 or higher on a standard rating scale, both at screening and at the start of the study
• You do not have any significant medical or mental health conditions that a study doctor believes would make participation unsafe
• You can understand the study procedures and are able to sign a consent form written in English
• You have access to a computer or smartphone with internet or cell service to complete online surveys and monitoring

Who may not be able to join:

• You have been diagnosed with a sleep-related breathing disorder, narcolepsy, sleepwalking, or sleep paralysis
• You screen positive for sleep apnea based on a questionnaire or a home sleep test showing certain levels of breathing interruptions or drops in blood oxygen during sleep (confirm with trial site)
• You are currently receiving any treatment for insomnia, whether that is therapy (such as talk therapy for sleep) or medication
• You are currently taking any prescribed or over-the-counter medication or supplement to help with sleep (such as zolpidem/Ambien), or you are unable to stop taking such a product
• You are currently taking benzodiazepines (such as Valium or Xanax), other opioids besides buprenorphine, antipsychotics, or other medications that affect the brain and nervous system that could increase safety risks
• You have a current diagnosis of alcohol or drug use disorder (other than nicotine) and have used non-prescribed substances in the past 3 months
• You use cannabis/marijuana more than 3 days per week
• You have an uncontrolled serious mental health condition such as Bipolar I Disorder, ADHD, Schizophrenia, schizoaffective disorder, major depression with psychotic features, or a neurological disorder
• You have an uncontrolled serious condition affecting the nervous system, heart, or lungs, such as a seizure disorder, recent heart attack, stroke, or a recent hospital stay for a lung condition
• Your heart test (ECG) at the start of the study shows a significant abnormality, including a specific heart rhythm measurement (QTc) above 450ms
• You currently have significant thoughts of harming yourself or others, or you have attempted suicide in the past 6 months
• Your blood test results show that your liver or kidney function values are significantly above the normal range (confirm with trial site for specific numbers)
• You are pregnant, breastfeeding, or — if there is a possibility you could become pregnant — you are unwilling to use an acceptable form of birth control during the study
• You are currently taking certain prescription or over-the-counter medications or supplements that are known to strongly interact with how the body processes some drugs — this includes certain antibiotics, antifungals, HIV medications, and herbal supplements such as St. John's Wort (confirm with trial site for the full list)
• You are currently taking a sleep medication called lemborexant, or you have had a bad reaction to lemborexant or similar medications in the past
• You are currently incarcerated or facing upcoming incarceration

Important: Always verify eligibility with the trial site directly before applying.