Opioid Use Disorder 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 | |
---|---|---|---|
Recruiting |
NCT06021431 -
Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT
|
N/A | |
Completed |
NCT06266572 -
Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment
|
Phase 1 | |
Recruiting |
NCT05037682 -
Pain and Opioid Management in Older Adults
|
N/A | |
Completed |
NCT06200740 -
Remotely Observed Methadone Evaluation
|
N/A | |
Not yet recruiting |
NCT06441604 -
Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
|
Phase 2 | |
Recruiting |
NCT06028126 -
Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial
|
N/A | |
Completed |
NCT02440256 -
Expanded HIV Care in Opioid Substitution Treatment (EHOST) Trial
|
N/A | |
Completed |
NCT02559973 -
Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder
|
Phase 1 | |
Completed |
NCT02593474 -
Medication-Assisted Treatment for Youth With Substance Use Disorders
|
Phase 1 | |
Completed |
NCT05587998 -
A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.
|
Phase 1 | |
Terminated |
NCT04577144 -
An Observational Study of Environmental and Socioeconomic Factors in Opioid Recovery - Long Term
|
||
Recruiting |
NCT06001437 -
Following Outcomes Remotely Within Addiction Recovery Domains
|
||
Recruiting |
NCT05976646 -
Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion
|
Phase 1/Phase 2 | |
Completed |
NCT05546229 -
Assessment of Methadone and Buprenorphine in Interstitial Fluid
|
||
Not yet recruiting |
NCT06104280 -
Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment
|
N/A | |
Not yet recruiting |
NCT06416020 -
Integrating MOUD in African American Community Settings (Better Together)
|
N/A | |
Recruiting |
NCT06206291 -
Cannabidiol for Opioid Addiction
|
Phase 2 | |
Completed |
NCT05552040 -
START NOW in the Treatment of Opioid Addicted Individuals
|
N/A | |
Recruiting |
NCT05459922 -
Adjunctive Bright Light Therapy for Opioid Use Disorder
|
N/A | |
Recruiting |
NCT05343169 -
Community-based Education, Navigation, and Support Intervention for Military Veterans
|
N/A |