Clinical trials: Opioid-related Disorders
Cocaine Abuse
ALK33BUP-101: Safety and Pharmacodynamic Effects of ALKS 33-BUP Administered Alone and When Co-administered With Cocaine
The purpose of this study is to assess the safety and tolerability of ALKS33-BUP when administered to opioid-experienced cocaine abusers.
- Trial name
- NCT01366001
- Testing
- ALKS 33-BUP, ALKS 33
- Where
- United States
- Volunteers
- 33 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-Induced Bowel Dysfunction
Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone
The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with opioid-induced bowel dysfunction (OBD).
- Trial name
- OPAL (NCT00597428)
- Testing
- Lubiprostone
- Where
- 114 sites in United States, Canada
- Volunteers
- 437 people
- Sponsor
- Sucampo Pharma Americas, LLC
Opioid-Induced Constipation
Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness
This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness…
- Trial name
- NCT00672139
- Testing
- Methylnaltrexone bromide
- Where
- 46 sites in United States, Australia and 8 more
- Volunteers
- 156 people
- Sponsor
- Bausch Health Americas, Inc.
Chronic Pain, Opioid Induced Constipation
Naloxone SR Capsules in Patients With Opioid Induced Constipation
For many patients taking opioids for pain relief one of the most distressing side effects is constipation. Naloxone is effective in the reversal of the effects of opioids and is used following opioid overdose.
- Trial name
- NCT00984334
- Testing
- Naloxone SR 5 mg capsules, Naloxone SR 10 mg capsules, Naloxone SR 20mg capsules
- Where
- 8 sites in Germany, United Kingdom
- Volunteers
- 40 people
- Sponsor
- S.L.A. Pharma AG
Substance Abuse, Criminal Behavior
An Evaluation of the NJSPB SCF Project for Opioid-Involved High-Risk Parolees
This study entails an evaluation of the New Jersey State Parole Board Swift, Certain, and Fair (SCF) Supervision Program. The purpose of the evaluation is to test whether subjects assigned to SCF Supervision perform better than…
- Trial name
- NCT03812484
- Testing
- SCF Supervision, Parole-as-Usual
- Where
- United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Botec Analysis, LLC
Opioid-use Disorder
A Remote, Decentralized Opioid Use Disorder Study to Evaluate Patient Engagement With a Game-Based Digital Therapeutic
The purpose of this study is to evaluate how patients use and engage with a game-based mobile application that is designed to treat opioid use disorder.
- Trial name
- NCT04542642
- Testing
- reSET-O, PEAR-008
- Where
- 2 sites in United States
- Volunteers
- 52 people
- Sponsor
- Pear Therapeutics, Inc.
Opioid Use Disorder
A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.
This is a Phase 1, single-centre, randomized, double-blind, placebo-controlled, 2 fixed sequences, multiple dose study in healthy male and/or female recreational opioid users.
- Trial name
- NCT05587998
- Testing
- Morphine, AZD4041
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Pain, Opioid Induced Constipation
Non-interventional Study Comparing Targiniq and Oxycodone/Laxatives
The objective of the non-interventional study is to compare the quality of life, health care resource use and costs between the use of a combination of oxycodone and naloxone (Targiniq) versus oxycodone and laxatives for patients…
- Trial name
- NCT01812733
- Where
- Sweden
- Volunteers
- 37 people
- Sponsor
- Mundipharma AB
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
Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder
This study is examining the use of Tezampanel (TZP) for treatment of Opioid Withdrawal Syndrome (OWS) in participants with Opioid Use Disorder (OUD).
- Trial name
- NCT06538558
- Testing
- Tezampanel
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Proniras Corporation
Opioid Dependence
The Safety of Using Buprenorphine With Naloxone in a Buccal Film to Initiate Treatment of Opioid Dependent Subjects
A randomized, double blind, active controlled study in approximately 40 opioid dependent subjects. Study duration is up to five days and includes a maximum of 3 days confinement in the clinic.
- Trial name
- NCT02516436
- Testing
- BEMA Buprenorphine NX, Buprenorphine
- Where
- 3 sites in United States
- Sponsor
- BioDelivery Sciences International
Opioid-use Disorder
Evaluation of Long-term Buprenorphine Plasma Exposure
The study objective is to characterise the long-term plasma exposure to buprenorphine after stopping SUBLOCADE treatment. There are no interventions planned.
- Trial name
- NCT03752528
- Testing
- Blood sample collection, Urine sample collection
- Where
- 11 sites in United States
- Volunteers
- 53 people
- Sponsor
- Indivior Inc.
Withdrawal Symptoms
A Study to Evaluate Withdrawal Effects Following Dosing of Oxycodone/Naltrexone in Methadone-Maintained Subjects
This single-center study is a randomized, double-blind, active-controlled, multiple-dose, parallel group study to evaluate the potential withdrawal effects, safety and tolerability, and pharmacokinetic and pharmacodynamic effects…
- Trial name
- NCT02391571
- Testing
- Oxycodone/Naltrexone Capsules, Oxycodone
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Elite Laboratories, Inc
Healthy Volunteer Study, Opioid-use Disorder
A Phase 1 Study Investigating the Safety, Tolerability and Pharmacokinetics of KNX100 in Healthy Volunteers
The primary objectives of this study are to evaluate the safety and tolerability of KNX100 administered orally as a single and multiple ascending doses in healthy volunteers.
- Trial name
- KTX101 (NCT04901078)
- Testing
- KNX100
- Where
- Australia
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Kinoxis Therapeutics Pty Ltd
Constipation, Signs and Symptoms, Digestive
Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients
To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC) or at risk of OIC.
- Trial name
- NCT02099591
- Testing
- Naloxegol
- Where
- 16 sites in Denmark, Israel and 3 more
- Volunteers
- 61 people
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
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 Dependence
INDV-2000 First in Human
This study is a single ascending dose (SAD) study conducted to identify the maximum tolerated dose (MTD) of INDV-2000. After completion of the SAD portion of the study and acceptable safety evaluation, a food-interaction…
- Trial name
- NCT04413552
- Testing
- INDV-2000
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Indivior 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-use Disorder, Opioid-related Disorders
An Observational Study of Environmental and SocioEconomic Factors in Opioid Recovery
The RECOVER Study will examine clinical, environmental and socioeconomic factors in recovery from opioid use disorder (OUD) over a 24-month period following exit from a Phase III clinical program for a buprenorphine…
- Trial name
- RECOVER® (NCT03604861)
- Testing
- Not applicable - no defined intervention
- Where
- 35 sites in United States
- Volunteers
- 534 people
- Sponsor
- Indivior Inc.