Clinical trials: Opioid Addiction
Opioid-related Disorders, Opioid Addiction
ER/LA Opioid Surveillance for Emergency Department Visits and Hospitalizations for Overdose and Poisoning
Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency Department visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02866266
- Testing
- Retrospective database review
- Volunteers
- 183,452 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Opiate-related Disorders, Opiate Dependence
Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED)
This study is designed to determine if opioid dependent subjects who are already receiving Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex® to Suboxone®.
- Conditions
- Opiate-related Disorders, Opiate Dependence, Drug Abuse
- Trial name
- NCT00684073
- Testing
- buprenorphine, buprenorphine/naloxone
- Volunteers
- 60 people
- Sponsor
- Indivior Inc.
Opioid Dependence
ALK21-025: Vivitrol's Cost and Treatment Outcomes Registry
The objective of the VIVITROL Registry is to gather real world data on opioid dependence and to provide understanding of the health economics of opioid dependence.
- Trial name
- VICTORY (NCT01422837)
- Where
- 31 sites in United States
- Volunteers
- 403 people
- Sponsor
- Alkermes, Inc.
Opioid Use Disorder
Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
This study will evaluate the efficacy, safety, and tolerability of oral naltrexone used in conjunction with buprenorphine in adults with Opioid Use Disorder transitioning from buprenorphine maintenance prior to the first dose of…
- Trial name
- NCT02696434
- Testing
- Naltrexone, Buprenorphine
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Alkermes, Inc.
Opioid Dependency
Study of Probuphine in Patients With Opioid Dependence
Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low.
- Trial name
- PRO-809 (NCT00772785)
- Testing
- Probuphine (buprenorphine implant)
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Titan Pharmaceuticals
Opioid-Related Disorders, Opiate Addiction
Study to Validate Coded Medical Terms Used to Identify Opioid-Related Overdose in Databases Used for PMR Study 1B
The purpose of this study is to determine reliability of codes and data from electronic medical records to predict and measure overdose and death in patients prescribed opioid analgesics.
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02667197
- Testing
- Algorithm to determine overdose from opioid abuse
- Volunteers
- 2,701 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Heroin Addiction
Observational Study to Assess the Efficacy and Tolerability of Eptadone®, in Heroin Addicted Patients in a MMT
The efficacy and tolerability of Eptadone® in the context of a maintenance program will be evaluated in an observational prospective, multicenter study, in heroin addicted patients.
- Trial name
- METHODE (NCT02062723)
- Where
- 22 sites in Germany
- Volunteers
- 515 people
- Sponsor
- L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
Opioid-related Disorders
Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone
The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active…
- Trial name
- NCT00637000
- Testing
- Buprenorphine soluble film, Buprenorphine/naloxone film strip
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Indivior Inc.
Opioid Dependence, Methadone Withdrawal Syndrome
Pilot Study of Lofexidine and Methadone Pharmacodynamic Interaction in Methadone Maintained Patients
The primary objective of this study is to assess QTc (an interval of the heart rhythm) interaction effects between lofexidine and methadone.
- Trial name
- NCT01558934
- Testing
- Lofexidine HCl
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Addiction, Opioid Dependence
Exploratory Dose Ranging Study Assessing APH-1501 for the Treatment of Opioid Addiction
The purpose of this study is determine the safety, efficacy and tolerability of a novel drug APH-1501 as a pharmacotherapy for Opioid Dependence. The investigators will evaluate the safety of escalating doses APH-1501.
- Conditions
- Addiction, Opioid Dependence, Opioid Withdrawal
- Trial name
- NCT03813095
- Testing
- APH-1501
- Volunteers
- 32 people
- Sponsor
- Aphios
Buprenorphine, Naloxone
Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)
The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic…
- Conditions
- Buprenorphine, Naloxone, Opiate-related Disorders, Opiate Dependence
- Trial name
- OPUS R (NCT00723697)
- Testing
- buprenorphine
- Volunteers
- 1,307 people
- Sponsor
- Indivior Inc.
Opioid Dependence, Opioid Use
Impact of a Behavioral Tele-health Program on the Quality of Recovery for Patients Undergoing Total Joint Replacement Surgery
The quality of recovery after surgery is multi-factorial and includes both physical and mental factors. Persistent pain after surgery is a common problem after major surgery and can result in persistent opioid use.
- Conditions
- Opioid Dependence, Opioid Use, Pain, Joint
- Trial name
- NCT05367050
- Testing
- Lucid Lane Therapy Program, Surgical Preparedness Course
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- Lucid Lane, Inc
Opioid Dependence, Acute Opioid Withdrawal Syndrome
Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal
The purpose of this study is to look at the efficacy and safety for lofexidine hydrochloride, an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids.
- Trial name
- NCT01863186
- Testing
- Lofexidine HCl, Open Label Lofexidine HCL
- Where
- 18 sites in United States
- Volunteers
- 603 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Opioid Related Disorder
Transfer of Subjects From Subutex/Suboxone to RBP-6300
This study is designed to determine if opioid dependent subjects who are already receiving Subutex and/or Suboxone can transfer to RBP-6300.
- Trial name
- NCT01582347
- Testing
- RBP-6300, Subutex®/Suboxone®
- Where
- 15 sites in Austria, Czechia and 2 more
- Volunteers
- 143 people
- Sponsor
- Indivior Inc.
Alcoholism
GSK1521498 Alcohol Interaction Study
The aim of the study is to assess the safety and tolerability of GSK1521498 in combination with alcohol and to determine the amount of GSK1521498 and alcohol in your blood after you have been given these together.
- Trial name
- NCT01366573
- Testing
- GSK1521498
- Where
- United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.
Opioid Dependence
Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low.
- Trial name
- PRO-807 (NCT00630201)
- Testing
- Probuphine (buprenorphine implant)
- Where
- 15 sites in United States
- Volunteers
- 62 people
- Sponsor
- Titan Pharmaceuticals
Opioid Dependence
Using mHealth to Aid Opioid Medication Adherence Pilot Study
The purpose of this study is to evaluate the usability of an interactive smartphone application (app) designed to engage and support patients receiving bup/nal.
- Trial name
- NCT02017041
- Testing
- Medsignals, smartphone app
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Care Team Solutions
Opioid-use Disorder
Improving Office Based Treatment of Opioid Use Disorder With Technology
The goal of this study is to evaluate whether using a novel drug-device combination to deliver buprenorphine/naloxone (B/N) to patients in office-based treatment for Opioid Use Disorder (OUD) is an effective way to improve…
- Trial name
- NCT03586466
- Testing
- BupreCare, Buprenorphine/naloxone, MEMS
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- MedicaSafe, Inc.
Opioid-Related Disorders, Opiate Addiction
Study to Eval Relation Btw Doctor/Pharmacy Shopping & Outcomes of Misuse, Diversion, Abuse, Addiction by Med Rec Review
To assess whether the percentage of patients with behaviors suggestive of misuse, diversion, abuse and/or addiction described in the medical record increases across pre-defined categories of increasing doctor/pharmacy shopping…
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02667210
- Testing
- Medical Record Review
- Volunteers
- 590 people
- Sponsor
- Member Companies of the Opioid PMR Consortium