Clinical trials: Opioid-related Disorders
Bowel Dysfunction
Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction
This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous methylnaltrexone to be conducted in patients with advanced medical illness and poorly controlled opioid induced constipation.
- Trial name
- NCT01367574
- Testing
- SC MNTX
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Bausch Health Americas, Inc.
Opioid Overdose
A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder
A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Nasal Powder.
- Trial name
- NCT04713709
- Testing
- Nasus Pharma FMXIN001, Nasal Naloxone liquid spray
- Where
- Canada
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Nasus Pharma
Opioid-induced Constipation
Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation
The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives.
- Trial name
- NCT01993940
- Testing
- Naldemedine
- Where
- 49 sites in United States
- Volunteers
- 553 people
- Sponsor
- Shionogi
Opiate Dependence, Drug Dependence
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)
Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.
- Trial name
- NCT00605033
- Testing
- Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484, Subutex, Buprenorphine Hydrochloride, SCH 28444
- Volunteers
- 241 people
- Sponsor
- Indivior Inc.
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
Neurostimulation to Improve NOWS Outcomes
The objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.
- Trial name
- SPROUT (NCT05129020)
- Testing
- Sparrow Fledging Therapy System
- Where
- 3 sites in United States
- Volunteers
- 52 people
- Sponsor
- Spark Biomedical, Inc.
Opioid Induced Constipation
A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)
A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation
- Trial name
- NCT01401985
- Testing
- TD-1211
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- Glycyx Therapeutics
Opioid-Induced Constipation (OIC)
A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation
The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.
- Trial name
- NCT01395524
- Testing
- NKTR-118
- Where
- 116 sites in United States, Australia and 2 more
- Volunteers
- 302 people
- Sponsor
- AstraZeneca
Opioid-use Disorder
Study of a Novel Subcutaneous Depot Formulation of Buprenorphine
INDV-6200 is being developed for the treatment of opioid dependency and is expected to provide sustained buprenorphine plasma concentrations.
- Trial name
- NCT03715634
- Testing
- INDV-6200, SL Buprenorphine, Nalorex
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Opioid-Related Disorders
Informational App Development for mHealth for Patient Self-Management of Opioid Use Disorder
This study will evaluate the feasibility of an app that provides drug information to people in recovery from opioid use disorder. This study is designed to test the prototype app, not to determine health outcomes.
- Trial name
- KIOS-I (NCT05859035)
- Testing
- KIOS Informational App
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Biomedical Development Corporation
Opioid Use Disorder
Evaluating the Efficacy of a Digital Platform to Deliver Comprehensive Treatment for Opioid Use Disorder
Buprenorphine Evaluation and Telehealth Study (BEaTS) Comparison of retention in care between telehealth-based care and treatment as usual.
- Trial name
- BEaTS (NCT05529225)
- Where
- 2 sites in United States
- Volunteers
- 159 people
- Sponsor
- Boulder Care
Opioid Abuse
Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse
The purpose of this study is to assess the abuse liability of 4 times (8 tablets) the usual recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40 mg alone in subjects with a history of opioid…
- Trial name
- NCT00699010
- Testing
- Acurox 5/30mg taken first, Oxycodone 5mg taken first
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Acura Pharmaceuticals Inc.
Opiate Dependence
ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals
The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.
- Trial name
- NCT00834080
- Testing
- Medisorb naltrexone 380 mg
- Where
- 11 sites in United States
- Volunteers
- 38 people
- Sponsor
- Alkermes, Inc.
Prescription Opioid Misuse
Reducing High School Athletes' Prescription Opioids Misuse and Diversion Through the Student Athlete Wellness Portal
The goal of this study is to prevent prescription opioid misuse among high school athletes by developing, demonstrating the feasibility, and evaluating the outcomes of an innovative digital intervention.
- Trial name
- NCT05209191
- Testing
- Student Athlete Wellness Portal
- Where
- 5 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Real Prevention, LLC
Nalbuphine, Opioid Abuse
Oral Abuse Potential Study of Nalbuphine
The purpose of this study is to measure the effects of a drug called nalbuphine (an opioid drug) compared with the effects of hydromorphone (an opioid drug) and placebo (contains no active drug ingredients).
- Trial name
- NCT04018664
- Testing
- Nalbuphine HCl solution
- Where
- Canada
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Trevi Therapeutics
Opioid Use Disorder, Opioid-related Disorders
Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder
A multi-center, open-label, long-term safety study in which approximately 600 subjects diagnosed with opioid use disorder will be enrolled.
- Trial name
- NCT02510014
- Testing
- SUBOXONE sublingual film, RBP-6000
- Where
- 42 sites in United States
- Volunteers
- 775 people
- Sponsor
- Indivior Inc.
Opioid Overdose
Pharmacokinetic Evaluation of a New Naloxone Nasal Swab, Naloxone Nasal Spray, and Intramuscular Naloxone Injection in Healthy Volunteers
The study consists of two Phases with the first phase (Pilot Phase) divided into two sub phases. In each study phase, subjects will be admitted to the clinical unit from 10 hours prior to the first drug administration on Day -1…
- Trial name
- NCT05363501
- Testing
- IM Naloxone Injection, Naloxone Nasal Spray, Naloxone Nasal Swab
- Where
- Canada
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Pocket Naloxone Corp
Opioid Dependency
Re-Treatment Study of Probuphine in Opioid Addiction
Probuphine (buprenorphine implant) is an investigational implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence.
- Trial name
- NCT01262261
- Testing
- Probuphine (buprenorphine implant)
- Where
- 18 sites in United States
- Volunteers
- 85 people
- Sponsor
- Titan Pharmaceuticals
Opioid-Related Disorders, Opiate Addiction
Cross-Sectional Study to Define and Validate "Doctor/Pharmacy Shopping" as Outcomes Suggestive of Abuse and/or Addiction
The purpose of this study is to formulate definitions of doctor/pharmacy shopping and evaluate its association with abuse/addiction
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02668549
- Testing
- DB review for Doctor/Pharmacy Shopping Behavior
- Volunteers
- 164,923 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Opioid-Related Disorders, Opiate Dependence
Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)
The purpose of this study is to evaluate the acceptability and safety of switching to Suboxone® (buprenorphine plus naloxone) and the effect of the switch on medication dispensing.
- Conditions
- Opioid-Related Disorders, Opiate Dependence, Drug Abuse
- Trial name
- NCT00725608
- Testing
- buprenorphine/naloxone
- Where
- Austria
- Volunteers
- 339 people
- Sponsor
- Indivior Inc.
Opioid-use Disorder
Single Ascending Dose Study of ALA-1000
An open-label study designed to evaluate the safety, tolerability, and pharmacokinetics of ALA-1000 in opioid-dependent subjects.
- Trial name
- NCT04122755
- Testing
- ALA-1000, buprenorphine sublingual film
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Alar Pharmaceuticals Inc.