Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University
About this trial
The goal of this clinical trial is to learn about how certain medications used to treat insomnia (e.g., Lemborexant) impact sleep, mood, and behavior in men and women with Opioid Use Disorder who are taking prescribed buprenorphine. The main questions it aims to answer are:
1. What is the effect of the study drug (lemborexant) on sleep outcomes? 2. What is the effect of the study drug (lemborexant) on impulsive behavior (as measured by computer test performance)? 3. What is the effect of the study drug (lemborexant) on mood and other behavior?
Researchers will compare lemborexant to placebo (e.g., sugar pill) to see if participants assigned to 8 weeks of treatment with lemborexant have greater improvements on the measures listed above.
Participants will take the study medication (or placebo) each night for 8 weeks and be asked to come for a total of 23 study visits. Most of these visits will be very short (15-30 minutes). The longer visits will include the screening visit (about 2-3 hrs), baseline visit (about 2.5 hrs), and the post-medication visit (about 2 hrs). Study visits will include things like taking surveys about sleep, drug use, and mood, completing urine drug testing, checking vital signs (e.g., blood pressure), and completing interviews with the study staff. Participants will also be asked to provide two blood samples (one during screening and one after taking the medication). For three two-week periods, participants will be asked to wear a watch to track sleep at home, and to keep a log of sleep and wake times.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be 18 + years-of-age
Meet current DSM-5 criteria for opioid use disorder (OUD) with at least moderate severity
Receiving outpatient treatment for OUD with sublingual buprenorphine film/tablets ranging 8mg to 24mg or with extended-release injectable buprenorphine
Stabilized on current buprenorphine dosage for at least 4 weeks without intention for dose change within next 3 months.
Disqualifiers
Current diagnosis of sleep-related breathing disorder, narcolepsy, somnambulism, or sleep paralysis
A positive screen for sleep apnea by the following: Sleep Disorders Screening Battery (STOP-BAG >5) OR home sleep apnea test using WatchPAT with Apnea Hypopnea Index (AHI) with 3% drop in oxygen saturation > 10 OR >50% of respiratory events being central if AHI is between 5-10 OR Oxygen Desaturation < 88% for > 10 minutes, OR oxygen desaturation index (ODI) using 3% drop in oxygen saturation > 10
Currently receiving treatment for insomnia (behavioral or pharmacologic)
Currently taking a medication to treat a sleep-related condition (e.g., zolpidem) or unable to discontinue over-the-counter drug or supplement used to treat sleep-related condition
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
DrugSubjects who are randomized to placebo will receive identical capsules to the study drug. During the 8-week intervention phase, participants will be instructed to take one capsule daily, approximately 5-30 minutes before going to bed
Lemborexant 10 MG
DrugDuring the 8-week intervention phase, participants will be instructed to take one capsule daily, approximately 5-30 minutes before going to bed
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: LemborexantExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Insomnia
Insomnia Severity Index will be used for assessing insomnia related symptoms. Scores on this measure range from 0-28, with higher scores indicating greater symptoms. Mean ISI score per group at baseline and at the end of 8-week treatment will be reported.
Time frame
from baseline to end of 8-week treatment2
Impulsivity
Impulsive responding will be measured by performance on the 5-trial adjusting delay discounting task, with the outcome being a derived discounting rate. Mean delay discounting rate per group at baseline and at the end of 8-week treatment will be reported.
Time frame
from baseline to end of 8-week treatmentSecondary outcomes
1
Insomnia related daily sleep metrics: Total sleep time (TST)
Total sleep time (TST) will be derived from actigraphy measured by an actigraphy watch. The descriptive statistics of derived TST score per group at baseline and end of 8-week treatment will be reported.
Time frame
from baseline to end of 8-week treatment2
Insomnia related daily sleep metrics: Wake After Sleep Onset (WASO)
Wake After Sleep Onset (WASO), will be derived from actigraphy measured by an actigraphy watch. The descriptive statistics of derived WASO score per group at baseline and end of 8-week treatment will be reported.
Time frame
from baseline to end of 8-week treatment3
Insomnia related daily sleep metrics: Sleep efficiency (SE)
Sleep efficiency (SE) will be derived from actigraphy measured by an actigraphy watch. The descriptive statistics of derived SE score per group at baseline and end of 8-week treatment will be reported.
Time frame
from baseline to end of 8-week treatment4
Insomnia related daily sleep metrics: Sleep onset latency (SOL)
Sleep onset latency (SOL) will be derived from actigraphy measured by an actigraphy watch. The descriptive statistics of derived SOL score per group at baseline and end of 8-week treatment will be reported.
Time frame
from baseline to end of 8-week treatmentSponsors and contacts
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Virginia Commonwealth University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov