Drug Interaction Clinical Trial
Official title:
Phase Ib/2a Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04645940 -
Fruquintinib Food Effect and Proton Pump Inhibitor Study
|
Phase 1 | |
Completed |
NCT04540965 -
Impact of a Histamine H2 Receptor Antagonist (H2RA) on the Pharmacokinetics (PK) of Telaglenastat in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04531072 -
Effect of Atazanavir-ritonavir on the Pharmacokinetics and Toxicity of Lumefantrine
|
Phase 4 | |
Completed |
NCT03385525 -
Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074
|
Phase 1 | |
Completed |
NCT05680792 -
Pharmacokinetic Interaction Between Nitazoxanide and Atazanavir/Ritonavir in Healthy Volunteers
|
N/A | |
Completed |
NCT05137548 -
A Drug-Drug Interaction Study Between ATI-2173 and Tenofovir Disoproxil Fumarate in Healthy Subjects
|
Phase 1 | |
Not yet recruiting |
NCT05525351 -
The Application and Validation of Triple Drug Response Surface Models on Density Spectral Array in Clinical Anesthesia
|
||
Terminated |
NCT01980342 -
Pharmacokinetics and Pharmacodynamics of the Etonogestrel Contraceptive Implant When Co-administered With Efavirenz
|
Phase 4 | |
Completed |
NCT04080596 -
DDI Study to Investigate the Impact of Itraconazole on the Pharmacokinetics of Dorzagliatin
|
Phase 1 | |
Recruiting |
NCT04593680 -
Assessment of Drug-drug Interactions Between Masculinizing Hormone Therapy and Antiretroviral Agents Concomitantly for Pre-exposure Prophylaxis Among Transgender Men
|
N/A | |
Active, not recruiting |
NCT04590417 -
Assessment of Drug-drug Interactions Between Feminizing Hormone Therapy and Emtricitabine/Tenofovir Alafenamide Concomitantly for Pre-exposure Prophylaxis Among Transgender Women
|
N/A | |
Completed |
NCT05633147 -
Effect of Clarithromycin on PK of Linaprazan, Linaprazan on PK of Clarithromycin and Linaprazan on PK of Midazolam
|
Phase 1 | |
Completed |
NCT02391688 -
Evaluation of the Potential Pharmacokinetic Interactions Between Probe Drugs in the Geneva Phenotyping Cocktail
|
Phase 1 | |
Completed |
NCT00806299 -
Loperamide Grapefruit Juice Interaction PK Trial
|
Phase 1 | |
Completed |
NCT03336346 -
Effect of Dolutegravir on Etonogestrel Levels in HIV-infected Women in Botswana
|
||
Completed |
NCT03187015 -
A Study to Examine the Effects of Entinostat on Midazolam in Healthy Adult Subjects
|
Phase 1 | |
Not yet recruiting |
NCT04463576 -
Drug Interactions in Hospital Information System. The PRoSIT System..
|
||
Not yet recruiting |
NCT03920566 -
The Effect of ENZAlutamide on the Anti-Xa Levels of Patients Receiving DOACs
|
||
Completed |
NCT03011996 -
To Investigate PK and PD of CJ-12420, Clarithromycin, Amoxicillin After Multiple Dose Administration
|
Phase 1 | |
Completed |
NCT04902105 -
Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of UGTs on the PK of Ecopipam and Its Active Metabolite
|
Phase 1 |