Clinical trials: Buprenorphine
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.
Respiratory Depression
Single Dose Crossover Study to Compare the Respiratory Drive After Administration of Belbuca, Oxycodone and Placebo.
The purpose of this study is to explore and compare VRH after administration of Belbuca, Oxycodone HCl and Placebo in recreational opioid users.
- Trial name
- NCT03996694
- Testing
- Belbuca 300 µg, Belbuca 600 µg, Belbuca 900 µg
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- BioDelivery Sciences International
Opioid Dependence, Buprenorphine Withdrawal Syndrome
Pharmacokinetic & Pharmacodynamic Interaction of Lofexidine and Buprenorphine in Buprenorphine Maintained Patients
The primary objective of this study is to assess lofexidine related effects on QTc (an interval of the heart rhythm) in subjects receiving buprenorphine maintenance.
- Trial name
- NCT01820442
- Testing
- Lofexidine HCl, Lofexidine-matching sugar pill
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Opioid Dependence
Evaluation of BEMA® Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects
This is a randomized, double blind, placebo controlled study in opioid dependent subjects. Subjects meeting entry criteria will be treated with multiple doses of B-BNX or B-Placebo, with non-responders rescued within 6 hours.
- Trial name
- NCT01713803
- Testing
- Buprenorphine and naloxone
- Where
- United States
- Sponsor
- BioDelivery Sciences International
Pain
Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children
The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years.
- Trial name
- NCT01324570
- Testing
- Buprenorphine transdermal system
- Where
- 22 sites in United States
- Volunteers
- 41 people
- Sponsor
- Purdue Pharma LP
Opioid Dependence, on Agonist Therapy
Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults
The purpose of this study was to assess retention in treatment after induction with buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after stabilization with BNX sublingual tablets compared…
- Trial name
- ISTART (NCT01908842)
- Testing
- BNX sublingual tablets, BNX sublingual film, Buprenorphine
- Where
- 36 sites in United States
- Volunteers
- 759 people
- Sponsor
- Orexo AB
Drug Addiction
Survey of Buprenorphine Use Among "Out of Care" Population in France (P04933)(COMPLETED)
This study was a survey of drug users who obtain buprenorphine from the black market and have used buprenorphine during the last month.
- Trial name
- NCT00756353
- Volunteers
- 600 people
- Sponsor
- Indivior Inc.
Opioid Use Disorder
Single-dose, Study of RBP-6000 in Opioid Dependent Individuals
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of an injection of RBP-6000.
- Trial name
- NCT02765867
- Testing
- RBP-6000
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Indivior Inc.
Opioid Use Disorder
A Study to Assess the Safety and Efficacy of ASP8062 as an Add-on Therapy to Buprenorphine/Naloxone in Participants With Opioid Use Disorder
The purpose of this study is to evaluate the efficacy; safety and tolerability of ASP8062 compared with placebo ASP8062 as add-on therapy to buprenorphine/naloxone.
- Trial name
- NCT05062577
- Testing
- ASP8062, buprenorphine/naloxone
- Sponsor
- Astellas Pharma Global Development, Inc.
Opioid-Related Disorders, Opiate Dependence
Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)
The aim of this post marketing surveillance study is to investigate the retention rate after 12 months of drug dependence treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid dependent patients under real life…
- Conditions
- Opioid-Related Disorders, Opiate Dependence, Drug Abuse
- Trial name
- NCT00723749
- Testing
- Buprenorphine/Naloxone
- Volunteers
- 384 people
- Sponsor
- Indivior Inc.
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
Dental Pain
Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain
The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.
- Trial name
- NCT00941304
- Testing
- Oxycodone, Buprenorphine
- Where
- 3 sites in United States
- Volunteers
- 153 people
- 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.
Chronic Lower Back Pain, Chronic Pain
Buprenorphine (CAM2038) in Subjects With a Recent History of Moderate to Severe Chronic Low Back Pain
This is a Phase III, placebo-controlled, multicenter study with an enriched-enrollment withdrawal (EEW) design to evaluate the efficacy and safety of CAM2038 in opioid-experienced subjects with moderate to severe CLBP that…
- Trial name
- CAM2038 (NCT02946073)
- Testing
- buprenorphine
- Where
- 69 sites in United States
- Volunteers
- 1,053 people
- Sponsor
- Braeburn Pharmaceuticals
Opiate Dependency Relapse
Using mHealth to Aid Opioid Addicts
The purpose of the proposed study is perform focus groups to identify and prioritize features of the SubAID application (APP). The SubAID APP is smartphone APP being created to support patients self-managing…
- Trial name
- NCT01955902
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Care Team Solutions
Osteoarthritis
Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain
The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip…
- Trial name
- NCT00312572
- Testing
- Buprenorphine transdermal patch
- Where
- 36 sites in United States
- Volunteers
- 204 people
- Sponsor
- Purdue Pharma LP
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 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.
Opioid Use Disorder, Severe, Opioid Use Disorder, Moderate
SUBLOCADE Rapid Initiation Extension Study
A single center, open-label SUBLOCADE treatment extension study in which up to 25 participants diagnosed with moderate to severe opioid use disorder (OUD) could be enrolled.
- Trial name
- NCT04060654
- Testing
- Sublocade
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Indivior Inc.
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