Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT06981195
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Subjects 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 — DRUG
    During the 8-week intervention phase, participants will be instructed to take one capsule daily, approximately 5-30 minutes before going to bed

Study Details

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.

Key Dates

Start date
May 27, 2025
Status verified
Jun 2025
Primary completion
Jul 30, 2029
Completion
Jul 30, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Placebo Comparator: Placebo
    Subjects who are randomized to placebo will receive identical capsules to the test product, administered orally.
  • Experimental: Lemborexant
    Lemborexant (trade name Dayvigo), 10mg capsules, administered orally

Primary Outcome Measure

Insomnia [ Time Frame: from baseline to end of 8-week treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VCU Institute for Drug and Alcohol StudiesRichmondVirginia23219-

Find similar trials in Richmond, VA

By condition
InsomniaSubstance use disorder
By specialty
Mental healthSleep medicineBehavioral healthAddiction medicine
By research site
VCU Institute for Drug and Alcohol Studies· Richmond, VA

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