Phase 2 Completed N=18 Randomized Triple-blind Treatment

Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder

Drug Interaction · Analgesics · Opioid Use Disorder

Source: ClinicalTrials.gov NCT04818086 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2024

Primary outcomePrimary: Change in Pulse Oximetry During the Baseline Visit — -0.17; -0.33 percentage of oxygen saturation

Summary

The purpose of this research study is to test the safety, tolerability, drug interactions with buprenorphine-naloxone, and effectiveness lemborexant when used to treat Opioid Use Disorder.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pulse Oximetry During the Baseline Visit	-0.17; -0.33	—
PRIMARY Change in Pulse Oximetry During Week 1 Visit	-0.17; -0.50	—
PRIMARY Change in Pulse Oximetry During Week 2 Visit	-0.27; -0.20	—
PRIMARY Change in Blood Pressure During Baseline Study Visit	-9.42; -2.50	—
PRIMARY Change in Blood Pressure During Week 1 Study Visit	-6.58; -4.50	—
PRIMARY Change in Blood Pressure During Week 2 Study Visit	1.09; -3.60	—
PRIMARY Change in Patient Consciousness During the Baseline Visit	-0.17; 0	—
PRIMARY Change in Patient Consciousness During the Week 1 Study Visit	0.00; 0.33	—
PRIMARY Change in Patient Consciousness	-0.18; -0.20	—
PRIMARY Change in Buprenorphine Plasma Concentration (PK) During the Baseline Visit	0.26	—
PRIMARY Change in Buprenorphine Plasma Concentration (PK) During Week 1 Study Visit	0.15	—
PRIMARY Change in Buprenorphine Plasma Concentration (PK) During Week 2 Study Visit	0.12	—
PRIMARY Change in Lemborexant PK During Baseline Study Visit	—	—
PRIMARY Change in Lemborexant PK During Week 1 Study Visit	—	—
PRIMARY Change in Lemborexant PK During Week 2 Study Visit	—	—
PRIMARY Change in Respiration During the Baseline Study Visit (Pre- to Post-dose)	1.0; 1.40	—
PRIMARY Change in Respiration During the Week 1 Study Visit (Pre- to Post-dose)	1.67; 0.50	—
PRIMARY Change in Respiration During Week 2 Study Visit (From Pre- to Post-dose)	2.18; 1.60	—
SECONDARY Change in Drug Effects During Baseline Study Visit (Pre- to Post- Dose)	21.0; 7.33	—
SECONDARY Change in Drug Effects During Week 1 Study Visit (Pre- to Post- Dose)	14.50; 5.33	—
SECONDARY Change in Drug Effects During Week 2 Study Visit (Pre- to Post Dose)	5.45; 18.00	—
SECONDARY Change in Opioid Craving During Each Visit (Pre- to Post- Dose)	-025; 3.0	—
SECONDARY Change in Opioid Withdrawal Effects During Baseline Visit (Pre- to Post- Dose)	-1.92; -.033	—
SECONDARY Change in Opioid Withdrawal Effects During Week 1 Visit (Pre- to Post- Dose)	-0.25; -0.17	—
SECONDARY Change in Opioid Withdrawal Effects During Week 2 Visit (Pre- to Post- Dose)	-0.45; 0	—
SECONDARY Change in Objective Opioid Withdrawal During Baseline Study Visit (Pre- to Post- Dose)	-0.83; -0.17	—
SECONDARY Change in Objective Opioid Withdrawal During Week 1 Study Visit (Pre- to Post-dose)	-0.50; -0.17	—
SECONDARY Change in Objective Opioid Withdrawal During Week 2 Study Visit (Pre- to Post- Dose)	-0.27; 0	—
SECONDARY Impulsivity	-40.63; -1.25	—
SECONDARY Impulsivity	-40.63; -1.25	—
SECONDARY Impulsivity	-40.63; -1.25	—

Eligibility Criteria

Inclusion Criteria

Males and females between 18 - 65 years-of-age;
Understand the study procedures and provide written informed consent in English language;
Meet current DSM-5 criteria for opioid use disorder, of at least moderate severity, currently engaged medication assisted treatment at a buprenorphine-naloxone sublingual film daily dose ranging from 8mg/2mg to 24mg/6mg or buprenorphine sublingual tablet 5.7mg/1.4mg to 17.1/4.3 once daily for at least last 2 weeks;
Have a positive urine drug screen for buprenorphine during screening and on admission to the clinical research unit to document buprenorphine use;
Have a Pittsburgh Sleep Quality Index (PSQI) Total Score of 6 or higher.

Exclusion Criteria

Contraindications for participation as determined by medical history and physical exam performed by study NP or study physician;
Pregnant or nursing women;
Baseline ECG with clinically significant abnormal conduction;
Uncontrolled serious psychiatric or major medical disorder, including COPD. Narcolepsy is also considered exclusionary;
Taking prescription or over-the counter drugs or dietary supplements known to significantly inhibit CYP3A4 (such as Clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir), or CYP3A4 inducers (such as phenobarbital, phenytoin, rifampicin, St. John's Wort, and glucocorticoids);
Prescribed medications for insomnia, or unable to discontinue over the counter drugs or dietary supplements used to treat insomnia on study days.
Current severe alcohol use disorder or current benzodiazepine use disorder
Current DSM-5 diagnosis of any psychoactive substance use disorder other than opioids, cocaine, marijuana, or nicotine, or mild or moderate alcohol use disorder. Diagnosis of mild to moderate use disorder for alcohol will not be considered exclusionary.
Any previous medically adverse reaction to opioids or lemborexant:
Significant current suicidal or homicidal ideation (C-SSRS "yes" answers on questions 4 or 5) or a history of suicide attempt within the past 6 months.
Subjects with Suicidal Behaviors Questionnaire-Revised score ≥8 at the screening visit.
Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04818086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.