Safety, Tolerability, and Pharmacokinetics of Naltrexone Implant (DLP-160)
NCT05304364 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-02-13
Summary
This is an Open-Label Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of Switching from Oral Naltrexone HCL to DLP-160 (Naltrexone implant) to Intramuscular Vivitrol®
Conditions
- Opiod Use Disorder
Interventions
- COMBINATION_PRODUCT
-
Combination Product: Naltrexone
Naltrexone Implant
Sponsors & Collaborators
-
Delpor, Inc.
lead INDUSTRY
Principal Investigators
-
Alex Choo, MD · CMAX
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-03-22
- Primary Completion
- 2022-10-21
- Completion
- 2022-11-19
Countries
- Australia
Study Locations
More Related Trials
-
ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals
NCT00834080 ·Status: COMPLETED ·Phase: PHASE3
-
Naltrexone Implants as Relapse Prevention
NCT00269607 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)
NCT02537574 ·Status: COMPLETED ·Phase: PHASE3
-
Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence
NCT01690546 ·Status: COMPLETED ·Phase: PHASE2
-
Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone
NCT00577408 ·Status: COMPLETED ·Phase: PHASE3
-
ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids
NCT01218984 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetic Study of Vivitrol in Healthy Participants
NCT04716881 ·Status: COMPLETED ·Phase: PHASE1
-
Injectable Pharmacotherapy for Opioid Use Disorders (IPOD)
NCT02110264 ·Status: COMPLETED ·Phase: PHASE3
-
Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction
NCT00521157 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Buprenorphine Naltrexone-P1 A-Cocaine
NCT00733720 ·Status: COMPLETED ·Phase: PHASE1
-
Depot Naltrexone Treatment of Opioid Dependent Parolees
NCT00756990 ·Status: COMPLETED ·Phase: NA
-
Improved Strategies for Outpatient Opioid Detoxification
NCT01377610 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol
NCT07269873 ·Status: RECRUITING ·Phase: PHASE1
-
ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence
NCT00678418 ·Status: COMPLETED ·Phase: PHASE3
-
Targeted Naltrexone to Support Individuals Participating in Dry January
NCT07132177 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent Persons
NCT05382091 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])
NCT00156936 ·Status: TERMINATED ·Phase: PHASE3
-
Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder
NCT05053503 ·Status: COMPLETED ·Phase: NA
-
Treatment Study Using Depot Naltrexone (1/6) Philadelphia Coord/Data Mgmt Site
NCT00781898 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Evaluation of Intranasal Naltrexone and Naloxone
NCT03851731 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Subjective Effects of PTI-801 in Non-Physically Dependent Subjects With a History of Drug Abuse
NCT00734461 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacodynamic Evaluation of Intranasal Nalmefene
NCT04828005 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder
NCT05011266 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Naltrexone in AUD Reward Drinkers
NCT05028062 ·Status: RECRUITING ·Phase: PHASE4
-
Employment-Based Depot Naltrexone Clinical Trial
NCT00684788 ·Status: COMPLETED ·Phase: PHASE2