Opioid Use Disorder Clinical Trial
Official title:
Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
This is a clinical trial to characterize the safety and pharmacokinetics of using extended-release buprenorphine (XR-BUP) as a novel low-dose buprenorphine induction strategy. Individuals with a DSM-5 diagnosis of OUD (n=30) will be admitted to an inpatient unit to complete study procedures over the course of 5 days. Participants will receive fentanyl to prevent the emergence of withdrawal. Each participant will then receive a single injection of XR-BUP after which study staff will monitor for any precipitated withdrawal.
The approach is to conduct a single ascending dose trial in a controlled human laboratory setting with individuals with a DSM-5 diagnosis of OUD (n=30) actively using illicit fentanyl. After obtaining informed consent and establishing eligibility, 10 participants will be scheduled for an inpatient visit lasting 5 days-4 nights and receive XR-BUP when not yet experiencing any opioid withdrawal. Participants will receive fentanyl to prevent the emergence of withdrawal, and on the following morning, receive XR-BUP 16mg in single-blind fashion. If at least 90% successfully complete induction (success defined as experiencing no precipitated withdrawal) with the 16mg dose, then we will proceed with 10 more participants to receive the 24mg dose. If at least 90% successfully complete induction the 24mg dose, then we will proceed with 10 more participants to the 32mg dose. Timed blood samples will be collected in heparinized Vacutainer tubes via a catheter in the antecubital vein at baseline, and at 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after the XR-BUP injection. ;
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 | |
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 |
NCT06416020 -
Integrating MOUD in African American Community Settings (Better Together)
|
N/A | |
Not yet recruiting |
NCT06104280 -
Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment
|
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 | |
Recruiting |
NCT06081985 -
Efficacy of Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder
|
N/A |