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

NCT ID: NCT04818086

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-03
• Study Completion Date: 2023-04-20

Brief 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.

Detailed Description

The purpose of this study is to test the effects of lemborexant when used in combination with opioids (including buprenorphine). We are also interested in learning lemborexant might help improve sleep problems and problems related to opioid use (e.g., cravings, withdrawal), in people with opioid use disorder. Study participants will be randomly assigned in a two to one ratio to receive either lemborexant or placebo. Lemborexant (DAYVIGO®) is approved by the U. S. Food and Drug Administration (FDA) for treatment of insomnia.

In this study, Participants will be asked to do the following things:

1. Visit the CARI clinic and/or Motivate clinic at Jackson Center to complete study screening.

2. Visit the VCUHS Clinical Research Unit to complete an outpatient blood draw/testing visit.

3. Take either lemborexant or the placebo, depending upon which group subjects are assigned to.

4. Complete two (2) overnight study visits at the VCUHS Clinical Research Unit.

5. Complete 8 outpatient follow-up visits (broken into 2 four day visit groupings)

6. Have an EKG during screening and at each study visit (outpatient and inpatient)

7. Have an IV inserted into your arm for blood draws at the outpatient blood draw visit and each inpatient visit.

8. Record sleep in a sleep diary.

9. Take surveys and answer questions about health, mental health, medications used, drug use, and cravings.

10. Complete tasks on the computer.

11. Complete physical exams during screening, outpatient and inpatient visits.

12. Give permission for the researchers to collect information about opioid treatment, medical status, and other information from your medical record.

Participation in this study will last approximately 4 weeks. Approximately 18 people will participate in the drug interaction phase of this study.

Conditions

Drug Interaction; Analgesics; Opioid Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Lemborexant Arm

Study Drug Dosage: 5 mg of lemborexant (Time 1) , and 10 mg of lemborexant (Time 2) combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film.

Group Type: ACTIVE_COMPARATOR

Lemborexant

Intervention Type: DRUG

Participants will complete 2 inpatient visits which may last up to 24 hours. The two visits will be approximately 14 days apart. During the inpatient visit they will receive 5 mg of lemborexant (first visit) and 10 mg of lemborexant (second visit).

Buprenorphine-naloxone

Intervention Type: DRUG

Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film.

Placebo Arm

Comparative placebo combined with 16 mg/4 mg of buprenorphine-naloxone sublingually as a film (at both Time 1 and Time 2)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will complete 2 inpatient visits which may last up to 24 hours. The two visits will be approximately 14 days apart. During the inpatient visit they will receive a placebo which is encapsulated to look the same as the intervention drug.

Buprenorphine-naloxone

Intervention Type: DRUG

Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film.

Interventions

Lemborexant

Participants will complete 2 inpatient visits which may last up to 24 hours. The two visits will be approximately 14 days apart. During the inpatient visit they will receive 5 mg of lemborexant (first visit) and 10 mg of lemborexant (second visit).

Intervention Type: DRUG

Placebo

Participants will complete 2 inpatient visits which may last up to 24 hours. The two visits will be approximately 14 days apart. During the inpatient visit they will receive a placebo which is encapsulated to look the same as the intervention drug.

Intervention Type: DRUG

Buprenorphine-naloxone

Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film.

Intervention Type: DRUG

Other Intervention Names

Dayvigo

Eligibility Criteria

Inclusion Criteria

1. Males and females between 18 - 65 years-of-age;

2. Understand the study procedures and provide written informed consent in English language;

3. 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;

4. Have a positive urine drug screen for buprenorphine during screening and on admission to the clinical research unit to document buprenorphine use;

5. Have a Pittsburgh Sleep Quality Index (PSQI) Total Score of 6 or higher.

Exclusion Criteria

1. Contraindications for participation as determined by medical history and physical exam performed by study NP or study physician;

2. Pregnant or nursing women;

3. Baseline ECG with clinically significant abnormal conduction;

4. Uncontrolled serious psychiatric or major medical disorder, including COPD. Narcolepsy is also considered exclusionary;

5. 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);

6. Prescribed medications for insomnia, or unable to discontinue over the counter drugs or dietary supplements used to treat insomnia on study days.

7. Current severe alcohol use disorder or current benzodiazepine use disorder

8. 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.

9. Any previous medically adverse reaction to opioids or lemborexant:

10. 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.

11. Subjects with Suicidal Behaviors Questionnaire-Revised score ≥8 at the screening visit.

12. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederick G Moeller, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

UG1DA050207

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20021136

Identifier Type: -

Identifier Source: org_study_id