Clinical trials: Buprenorphine
Healthy, Opioid Use
Buprenorphine-Fentanyl Interaction Study
An increase in overdose deaths has been attributed to widespread access to fentanyl and carfentanyl. The study is designed to determine if buprenorphine can change the respiratory depression response to intravenous (IV) fentanyl.
- Trial name
- NCT03747341
- Testing
- Buprenorphine Injectable Solution - Part A, Fentanyl - Part A, Ondansetron - Parts A + B
- Where
- Netherlands
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Low Back Pain
Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Low Back Pain
The primary objective of this study is to evaluate the efficacy and safety of BTDS compared to placebo in subjects with moderate to severe low back pain.
- Trial name
- NCT00346047
- Testing
- Buprenorphine Transdermal System
- Where
- 29 sites in Japan
- Volunteers
- 238 people
- Sponsor
- Mundipharma K.K.
Opioid Use Disorder
Multiple Dose Study of Blockade of Opioid Effects by Injections of Buprenorphine in Participants With Opioid Disorder
This is a multiple-dose study in non-treatment seeking male and female subjects with moderate to severe opioid use disorder who meet criteria from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) to…
- Trial name
- NCT02044094
- Testing
- Buprenorphine, buprenorphine and naloxone, hydromorphone
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Indivior Inc.
Opioid Use Disorder
SUBLOCADE Long-term Outcomes
This study will provide the opportunity to generate data on the long-term use of SUBLOCADE under real-world conditions, and to observe enduring changes in lifestyle, health, and sociodemographic factors that are part of the…
- Trial name
- NCT05860959
- Where
- 49 sites in United States, Australia and 2 more
- Volunteers
- 480 people
- Sponsor
- Indivior Inc.
Chronic Hepatitis C Infection, Chronic Hepatitis C
An Open-label, Single Arm, Phase 2 Study to Evaluate ABT-450/r/ABT-267 and ABT-333 With Ribavirin (RBV) in Adults With Genotype 1 HCV Infection Taking Methadone or Buprenorphine
The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir)…
- Trial name
- NCT01911845
- Testing
- ABT-450/r/ABT-267, ABT-333, Ribavirin (RBV)
- Volunteers
- 38 people
- Sponsor
- AbbVie
Osteoarthritis
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release in…
- Trial name
- NCT00312221
- Testing
- Buprenorphine, oxycodone immediate-release
- Where
- 23 sites in United States
- Volunteers
- 418 people
- Sponsor
- Purdue Pharma LP
Pain
A Dose Proportionality and Bioavailability Assessment of Buprenorphine Transdermal Delivery System Second Generation Patches
The purpose of this study is to obtain pharmacokinetic data for a dose proportionality and relative bioavailability assessment of 2nd generation BTDS patches compared to 1st generation BTDS patches.
- Trial name
- NCT02160067
- Testing
- Second generation BTDS patch, First generation BuTrans patch
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Mundipharma Research Limited
Osteoarthritis
Buprenorphine in the Treatment of Osteoarthritis (OA) in the Elderly
The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).
- Trial name
- NCT00324038
- Testing
- Buprenorphine, Codeine paracetamol
- Where
- United Kingdom
- Volunteers
- 219 people
- Sponsor
- Napp Pharmaceuticals Limited
Back Pain Lower Back Chronic
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in…
- Trial name
- NCT00313014
- Testing
- Buprenorphine, Oxycodone Immediate-Release
- Where
- 85 sites in United States
- Volunteers
- 660 people
- Sponsor
- Purdue Pharma LP
Opioid Dependency
A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction
Probuphine (buprenorphine implant) is an implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will confirm the efficacy of Probuphine vs.
- Trial name
- NCT01114308
- Testing
- Probuphine (buprenorphine implant), Buprenorphine
- Where
- 20 sites in United States
- Volunteers
- 287 people
- Sponsor
- Titan Pharmaceuticals
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.
Back Pain Lower Back Chronic
Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).
- Trial name
- NCT01125917
- Testing
- Buprenorphine transdermal patch
- Where
- 84 sites in United States
- Volunteers
- 354 people
- Sponsor
- Purdue Pharma LP
HIV, Pharmacokinetics
TMC125-TiDP2-C188: A Phase I, Open-label Trial to Investigate the Pharmacokinetic Effect of Multiple-dose TMC125 on Buprenorphine and Norbuprenorphine Administered in HIV-negative Patients on Stable Buprenorphine/Naloxone Maintenance Therapy.
TMC125 is from the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs). NNRTIs work by blocking reverse transcriptase, a protein that HIV needs to make more copies of itself.
- Trial name
- NCT00828815
- Testing
- TMC125
- Volunteers
- 22 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Opioid Related Disorders, Opiate Addiction
Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers
A study will be performed to evaluate changes in prescribing behavior of prescribers of ER/LA opioids
- Conditions
- Opioid Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02920762
- Testing
- on-interventional study - retrospective database review
- Volunteers
- 5,575,834 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Pain, Postoperative
Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain
This study will evaluate the safety and tolerability based on the incidence of adverse experiences of buprenorphine sublingual spray (0.5 milligrams [mg] three times daily [TID]) compared with standard post-operative narcotic…
- Trial name
- NCT03254459
- Testing
- Buprenorphine Sublingual Spray, Morphine, Oxycodone Hydrochloride
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- INSYS Therapeutics Inc
Osteoarthritis
Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).
- Trial name
- NCT01141283
- Testing
- Buprenorphine transdermal patch
- Where
- 42 sites in United States
- Volunteers
- 290 people
- Sponsor
- Purdue Pharma LP
Opioid-Related Disorders
Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions
The objective of this study was to prove the bioequivalence of Buprenorphine HCl 8 mg tablet under fasted conditions.
- Trial name
- NCT00992095
- Testing
- buprenorphine hydrochloride
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
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
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.
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.