Phase 2 N=40 Naloxone SR Capsules in Patients With Opioid Induced Constipation
Chronic Pain · Opioid Induced Constipation
Primary: Incidence and Severity of Treatment Emergent Adverse Events on Single Dosing. — 8; 5; 4; 6 participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=199 Naloxone for Optimizing Hypoxemia Of Lung Donors
Brain Death · Organ Donors · Lung Transplantation
Primary: Change in Oxygenation (P/F Ratio) From Baseline to Final Pre-recovery Arterial Blood Gas (ABG) — 81; 80 mm Hg
N/A N=48 Nalox-Comm: Naloxone Communication Training for Pharmacists
Naloxone
Primary: Change in Naloxone Dispensing Rate Over a 6-month Period — .0073; .0041 number of naloxone products dispensed — p=0.473
Phase 2 N=30 Naloxone, Hypoglycemia and Exercise
Diabetes Mellitus, Type 1
Primary: Change in Symptom Score — 25; 21 score on a scale
Phase 1 N=8 Pharmacokinetics of Intravenous and Intranasal Formulations of Naloxone in Healthy Volunteers.
Healthy
Primary: Effects of Naloxone on Heart Rate (HR). — 73.3; 70.6 bpm
Phase 1 N=13 Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg
Opioid Overdose
Primary: Change in Minute Ventilation 5 Minutes From Opioid Induced Nadir — 4.42; 2.03 L/min
Phase 1 N=21 Clinical Study to Investigate the Pharmacokinetics of Multiple Repeated Doses of Intranasal Naloxone
Healthy Subjects · Opioid Antagonist · Pharmacokinetics
Primary: First Timepoint When There is a Higher Naloxone Plasma Concentration in the 4 Naloxone Dose Arm (1 Every 2.5 Min) Compared to the 2 Naloxone Dose Arm (1 Every 2.5 Min)…
Phase 4 N=319 Increasing Naloxone Access for Persons Who Use Opioids
Naloxone
Primary: The Number of Participants That Completed the Training in 6 Months — 55; 56; 10; 9 Participants
N/A N=395 Naloxone Auto-injector as a Universal Precaution for Patients With Opioid Use Disorder
Opiate Antagonist Overdose · Opioid-Related Disorders
Primary: To Measure the Association of Take-home Naloxone With Overdose Reversals Performed by Patients With Opioid Use Disorder Enrolled in an Opioid Treatment Program — 73; 263…
N/A N=138 A Usability Assessment of Naloxone by Community Members
Drug Overdose
Primary: Successful Administration of Naloxone — 32; 41; 46 Participants
Phase 4 N=136 Ancillary Effects of Oral Naloxegol (Movantik)
Pain, Postoperative
Primary: Residual Urine Volume — 62; 114; 48; 31 ml — p=0.84
Phase 3 N=30 Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone
Opioid Dependence
Primary: Successful Induction Onto XR-NTX — 8 Participants
Phase 3 N=34 Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
Opiate Dependence
Primary: Post-Release Opioid Relapse — 6; 15 participants
Phase 1 N=7 Pharmacodynamic Evaluation of Intranasal Nalmefene
Pharmacodynamic
Primary: Change in Minute Ventilation — 3.432; 5.744 L/min — p=<0.0009
Phase 2 N=64 Optimal Dose of Prophylactic Naloxone in Reducing Opioid-Induced Side Effects in Children/Adolescents
Pain · Nausea · Pruritus
Primary: Number of Participants With Naloxone Side Effects — 32 participants
N/A N=84 Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
Pain, Postoperative · Postoperative Nausea and Vomiting · Scoliosis
Primary: Number of Hours Until Tolerating Oral Intake — 25.9; 25.0 hours
Phase 2 N=81 Memantine and Naltrexone Treatment for Opioid Dependence
Opioid Dependence
Primary: Retention in Treatment — 7; 5; 6 participants — p=0.32
Phase 2 N=27 ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids
Opiate Dependence
Primary: Slope Change From Baseline for Pupil Size — -0.5540; -0.3607; -0.1410 cm(2)/hr
Phase 4 N=256 Project OOPEN: Opioid Overdose Prevention, Education and Intervention
Opioid Overdose
Primary: Rate of Fatal Opioid Overdose — 2; 6 Participants
Phase 4 N=570 Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
Opioid Use Disorder
Primary: Time to Relapse (Intent to Treat Population) — 8.4; 14.4 weeks
Phase 2 N=6 Nalrexone Facilitated Discontinuation of Buprenorphine
Stable Opioid Dependence
Primary: Successful Discontinuation of Buprenorphine — 6 Participants
Phase 2 N=20 Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
Opioid-use Disorder
Primary: Successful Vivitrol Induction — 10 Participants
N/A N=98 Use of Virtual Reality for Overdose Management Educational Trainings
Drug Overdose · Virtual Reality
Primary: Change in Opioid Overdose Knowledge Scale (OOKS) From Pre- to Post-training — 2; 1 units on a scale — p=0.65
Phase 4 N=198 Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry
Heroin Dependence · Opioid-Related Disorders
Primary: Time-to-Relapse: XRNTX vs. ETAU Following Release From Jail — 8.6; 5.9 Weeks
Phase 2 N=16 Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence
Opioid Dependence
Primary: Successful Naltrexone Initiation — 11 Participants
Phase 1 N=56 Oral Abuse Potential Study of Nalbuphine
Nalbuphine · Opioid Abuse
Primary: To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main…
Phase 4 N=12 Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation
Constipation Drug Induced
Primary: Occurrence of Bowl Movement — 2; 2; 5 Participants
N/A N=105 Preventing Opioid Overdose Mortality in the United States
Opioid Overdose
Primary: Naloxone Coverage (Consistency) — 0.9; 0.4 proportion of participants — p=<0.01
N/A N=9 Aprepitant Effects on Oxycodone Response
Narcotic Abuse
Primary: Abuse Liability Proxy — 0.197; 0.483; 0.159; 7.678 units on a scale (points 0-100) — p=<.05
Phase 3 N=55 Memantine as a Supplement to Naltrexone in Treating Heroin Dependence
Opioid Dependence · Heroin Dependence
Primary: Opiate Use Measured by Urine Toxicology Results — 9; 10 Percent of total urine samples