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Lemborexant Arm for Drug Interaction

Phase 1 & 2
Waitlist Available
Led By Frederick G Moeller, MD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during each inpatient visit from admission to discharge, up to 24 hours
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new drug to treat opioid addiction.

Eligible Conditions
  • Drug Interaction
  • Opioid Analgesics

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during each inpatient visit from admission to discharge, up to 24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and during each inpatient visit from admission to discharge, up to 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Blood Pressure
Change in Buprenorphine Plasma Concentration (PK)
Change in Lemborexant PK
+3 more
Secondary outcome measures
Change in drug effects
Change in objective opioid withdrawal
Change in opioid craving
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Lemborexant ArmActive Control2 Interventions
Study Drug Dosage: 5 mg of lemborexant, and 10 mg of lemborexant combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film.
Group II: Placebo ArmPlacebo Group2 Interventions
Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film.

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
697 Previous Clinical Trials
22,884,948 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,465 Previous Clinical Trials
2,618,585 Total Patients Enrolled
Frederick G Moeller, MDPrincipal InvestigatorVirginia Commonwealth University
8 Previous Clinical Trials
7,766 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary objective of this research endeavor?

"This research project aims to measure the fluctuation of respiration over a 24-hour period. Secondary objectives include tracking changes in drug effects with the Drug Effects Questionnaire (DEQ), objective opioid withdrawal using the Clinical Opioid Withdrawal Scale (COWS) and Subjective Opioid Withdrawal Scale (SOWS). These tools feature likert scaled items, allowing participants to rate physical effects from "not at all" to "extremely"."

Answered by AI

Is enrollment for this research project still open?

"This clinical trial is currently recruitting participants, as evidenced by information on the clinicaltrials.gov website. The experiment was initially publicized on May 3rd 2021 and most recently revised on November 28th 2022."

Answered by AI

Is this research protocol recruiting individuals aged 65 or older?

"This trial has an age limit of 18 years to 65 years and is therefore accepting participants within that range."

Answered by AI

What studies are available that assess the efficacy of Lemborexant Arm?

"At the moment, 57 studies are running with Lemborexant Arm as part of their regimen and 14 have reached Phase 3. Durham, North carolina is a particularly active centre for these trials, but there exist 268 sites across the globe where patients can access this medication."

Answered by AI

How many participants are in this medical study?

"Affirmative. Visible on clinicaltrials.gov, this research study has been actively recruiting participants since May 3rd 2021 and was last modified November 28th 2022. The trial is seeking 18 patients at a single site for participation."

Answered by AI

Are there any restrictions on who may participate in this clinical research project?

"This research initiative is accepting 18 individuals with current opioid abuse between the ages of majority and seniority. Notably, applicants should possess a Pittsburgh Sleep Quality Index (PSQI) Total Score of 6 or more for eligibility."

Answered by AI

What is the therapeutic application of Lemborexant Arm?

"Lemborexant Arm is typically prescribed to address opioid-related issues, but can also be utilized in treatments for pruritus, pain or septic shock."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder
2021. "Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04818086.
~12 spots leftby Apr 2025
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