Clinical trials: Buprenorphine
Opioid Related Disorder
Multiple Dose Pharmacokinetics Depot Buprenorphine in Opioid-Dependent Subjects
This is an open-label study in treatment seeking opioid-dependent subjects for safety, tolerability, pharmacokinetics (PK), efficacy markers, and opioid receptor availability of subcutaneous injections of depot buprenorphine…
- Trial name
- NCT01738503
- Testing
- RBP-6000, Subutex
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Indivior Inc.
Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe
Computerized Chemosensory-Based Orbitofrontal Cortex (CBOT) for Opioid Use Disorder
Opioid Use Disorders (OUD) cause significant burden to individuals, families, and the society. Our product - Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) - offers a cost-saving, home-based, user-friendly…
- Conditions
- Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe, Withdrawal Symptoms, Craving
- Trial name
- CBOT-OUD (NCT04850664)
- Testing
- CBOT + TAU
- Where
- 4 sites in United States
- Volunteers
- 190 people
- Sponsor
- Evon Medics LLC
Healthy
Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions
The object of this study is to compare the rate and extent of absorption of an investigational formulation of buprenorphine 8 mg sublingual tablets manufactured by Barr Laboratories, Inc.
- Trial name
- NCT01157169
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Pain, Low Back Pain
Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).
- Trial name
- NCT01256450
- Testing
- Buprenorphine
- Where
- 24 sites in United States
- Volunteers
- 334 people
- Sponsor
- BioDelivery Sciences International
Opioid Dependency
Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France ("RIME")
Patients who admit to using buprenorphine by the intravenous route will be randomized to either Subutex or Suboxone and be followed up for 3 months to determine if there is less injection with Suboxone than with Subutex based…
- Trial name
- RIME (NCT00955162)
- Testing
- Buprenorphine (Subutex), Buprenorphine/naloxone (Suboxone)
- Where
- 20 sites in France
- Volunteers
- 270 people
- Sponsor
- Indivior Inc.
Moderate to Severe Opioid-use Disorder
Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users
The primary objective of the induction phase of the study is to compare treatment retention of participants following rapid induction or standard of care (SoC) induction onto extended-release buprenorphine.
- Trial name
- NCT04995029
- Testing
- Transmucosal Buprenorphine, Extended-release Buprenorphine
- Where
- 29 sites in United States, Canada
- Volunteers
- 785 people
- Sponsor
- Indivior Inc.
Opioid Use Disorder
Right Tools, Right Time, Right Place: Telehealth for Opioid Use Disorder in Vulnerable Settings
Our primary objective is to evaluate the ability of Boulder Care's telehealth-platform to create the necessary paradigmatic shift in Opioid Use Disorder (OUD) treatment to reach vulnerable populations, with targets that support…
- Trial name
- NCT07169409
- Testing
- Telemedicine Buprenorphine Treatment
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Boulder Care
Hepatitis C, Chronic
Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)
Although injection drug users represent the majority of new and existing cases of infection with hepatitis C virus (HCV), many lack access to treatment because of concerns about adherence, effectiveness, and reinfection.
- Trial name
- NCT00725751
- Testing
- Pegylated interferon alfa-2b (PegIFN-2b), Ribavirin
- Volunteers
- 353 people
- Sponsor
- Merck Sharp & Dohme LLC
Osteoarthritis
Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.
The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe…
- Trial name
- NCT00315458
- Testing
- Buprenorphine transdermal patch
- Where
- 48 sites in United States
- Volunteers
- 107 people
- Sponsor
- Purdue Pharma LP
Opiate Dependence, Drug Dependence
A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED)
The purpose of this study is to assess the acceptability and safety of Suboxone in heroin users as a replacement therapy for opioid dependency by comparing the clinical response of participants who are inducted directly onto…
- Conditions
- Opiate Dependence, Drug Dependence, Substance Dependence
- Trial name
- NCT00604188
- Testing
- Suboxone (SCH 000484), Subutex (SCH 028444)
- Volunteers
- 188 people
- Sponsor
- Merck Sharp & Dohme LLC
Osteoarthritis
Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase
The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control.
- Trial name
- NCT01135524
- Testing
- Buprenorphine transdermal patch
- Where
- 89 sites in United States
- Volunteers
- 196 people
- Sponsor
- Purdue Pharma LP
Healthy
A Single-Dose Study of an Investigational Capsule Formulation of 2 mg/0.5 mg Buprenorphine/Naloxone
A single-dose pilot study of an investigational capsule formulation of 2 mg/.05 mg Buprenorphine/Naloxone. NIDA Contract No. HHSN271200577414C
- Trial name
- NCT00880841
- Testing
- Buprenorphine / Naloxone
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- NanoSHIFT LLC
Opioid Dependence
A Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily SL Buprenorphine to Probuphine® Subdermal Implants
The primary objective of the study is to demonstrate maintenance of treatment efficacy when transferring adult outpatients with opioid dependence, who are clinically stabilized on 8 mg or less of sublingual (SL) buprenorphine…
- Trial name
- PRO-814 (NCT02180659)
- Testing
- sublingual buprenorphine tablets, Buprenorphine implant
- Volunteers
- 177 people
- Sponsor
- Titan Pharmaceuticals
Chronic Non-malignant Pain
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant…
- Trial name
- NCT00312195
- Testing
- Buprenorphine transdermal patch
- Where
- 42 sites in United States, United Kingdom
- Volunteers
- 267 people
- Sponsor
- Purdue Pharma LP
Opioid Use Disorder, Chronic Pain
Phase II Pharmacokinetics Study of CAM2038
Phase II, open label, partially randomized, three treatment group study designed to evaluate the steady state pharmacokinetics of buprenorphine and norbuprenorphine following repeated subcutaneous administrations of CAM2038.
- Trial name
- NCT02710526
- Testing
- CAM2038
- Where
- 3 sites in United States
- Volunteers
- 66 people
- Sponsor
- Braeburn Pharmaceuticals
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
Pain
An Assessment of Buprenorphine Transdermal Delivery System (BTDS) Patch Adhesion
The purpose of this study is to assess the adhesion of BTDS patch 40 µg/h.
- Trial name
- NCT02431624
- Testing
- BTDS
- Where
- United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Mundipharma Research Limited
Opioid Use Disorder, Opioid-related Disorders
Open-Label Treatment Extension Study
Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who complete the RB-US-13-0003 study (NCT02510014) and for whom a new treatment venue has not been identified or arranged.
- Trial name
- NCT02896296
- Testing
- RBP-6000
- Where
- 29 sites in United States
- Volunteers
- 208 people
- Sponsor
- Indivior Inc.
Healthy
A Study to Evaluate the Effect of ALKS 5461 on QT Intervals in Healthy Volunteers
This study will evaluate the effects of ALKS 5461 on QT intervals in healthy volunteers as well as evaluate the safety and tolerability of ALKS 5461.
- Trial name
- NCT02479308
- Testing
- Moxifloxacin, ALKS 5461
- Where
- United States
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- Alkermes, Inc.
Major Depressive Disorder
A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)
This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461.
- Trial name
- NCT02085135
- Testing
- ALKS 5461
- Where
- 9 sites in United States, Canada
- Volunteers
- 66 people
- Sponsor
- Alkermes, Inc.