Clinical trials: Buprenorphine
Opiate Dependence, Drug Dependence
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)
Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.
- Trial name
- NCT00605033
- Testing
- Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484, Subutex, Buprenorphine Hydrochloride, SCH 28444
- Volunteers
- 241 people
- Sponsor
- Indivior Inc.
Opioid Dependence, Opioid Related Disorders
Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine
This is a randomized, double-blind, placebo controlled, multicenter study in male and female participants who are seeking treatment for opioid use disorder.
- Trial name
- NCT02357901
- Testing
- SUBOXONE, RBP-6000
- Where
- 38 sites in United States
- Volunteers
- 665 people
- Sponsor
- Indivior Inc.
Opioid Use Disorder
A Study of Brenipatide in Participants With Opioid Use Disorder
The purpose of this study is to see if brenipatide, when compared to placebo, is safe and effective for participants with opioid use disorder, when used with buprenorphine with or without naloxone.
- Trial name
- RENEW-Op-1 (NCT07420283)
- Testing
- Brenipatide, Buprenorphine
- Where
- 61 sites in United States, Canada and 2 more
- Volunteers
- 465 people
- Sponsor
- Eli Lilly and Company
Healthy
Single Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations (Protocol ID 297307)
The purpose of this study is to determine whether the plasma levels of two different analgesic transdermal patch formulations lead to same plasma levels of the active ingredient after single dose application.
- Trial name
- NCT00469404
- Testing
- Buprenorphine
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
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)
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
Healthy
Examine Plasma Concentrations of Buprenorphine Following Reapplication of Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods
The purpose of this study is to determine the pharmacokinetics of BTDS following same-site patch reapplication after rest intervals.
- Trial name
- NCT01259102
- Testing
- Buprenorphine transdermal patch
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Healthy
Study to Assess the PK Profile of NanoBUP Capsules Relative to Suboxone
Phase 1 study to determine the pharmacokinetic profile of NanoBUP Capsules to Suboxone.
- Trial name
- NCT01260675
- Testing
- Buprenorphine HCl/Naloxone HCl
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- NanoSHIFT LLC
Back Pain
The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.
The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back…
- Trial name
- BP96-0604 (NCT00315445)
- Testing
- Buprenorphine transdermal patch, OXY/APAP
- Where
- 12 sites in United States
- Volunteers
- 134 people
- Sponsor
- Purdue Pharma LP
Opioid Dependence
An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects
This is an open label study in opioid dependent subjects maintained on a stabilized dose of Suboxone tablets or films. The purpose is to assess the safety and tolerability of BEMA Buprenorphine NX administered once daily for 12…
- Trial name
- NCT01666119
- Testing
- BEMA Buprenorphine NX films
- Where
- 10 sites in United States
- Volunteers
- 249 people
- Sponsor
- BioDelivery Sciences International
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
Refractory Major Depressive Disorder
A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)
This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.
- Trial name
- NCT03610048
- Testing
- ALKS 5461
- Where
- 34 sites in United States, Australia and 1 more
- Volunteers
- 175 people
- Sponsor
- Alkermes, Inc.
Osteoarthritis, Rheumatoid Arthritis
Efficacy and Safety of Buprenorphine Transdermal Patch in Non-cancer Pain of Moderate Intensity
This is a phase IV, open-label and single-arm study of patients with non-malignant pain due to osteoarthritis, rheumatoid arthritis, low back pain and joint/muscle pain, who were not responding to non-opioid analgesics.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain, Joint Pain
- Trial name
- NCT02519387
- Testing
- Buprenorphine Transdermal Patch
- Where
- 3 sites in Malaysia
- Volunteers
- 78 people
- Sponsor
- Mundipharma Pharmaceuticals Sdn. Bhd.
Major Depressive Disorder
A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)
This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.
- Trial name
- NCT03188185
- Testing
- ALKS 5461
- Where
- 35 sites in United States, Australia and 1 more
- Volunteers
- 278 people
- Sponsor
- Alkermes, Inc.
Healthy
Multiple Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations (Protocol ID: 855509)
The purpose of this study is to determine whether two different analgesic transdermal patch formulations lead to same plasma levels of active ingredient after multiple dose application.
- Trial name
- NCT00469053
- Testing
- Buprenorphine
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Opioid Use Disorder
Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AZD4041 Study in Opioid Use Disorder (Part 2).
The purpose of the study is to assess drug-drug interaction (DDI) and safety of AZD4041 and itraconazole in healthy participants (Part 1), and to assess efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD404…
- Trial name
- NCT06406400
- Testing
- AZD4041, Itraconazole, Buprenorphine
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- AstraZeneca
Opioid Use Disorder
A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine
This study is open to people between 18 and 65 years of age with opioid use disorder. Opioid use disorder is also called opioid addiction or opioid dependence.
- Trial name
- NCT06628622
- Testing
- BI 1356225
- Where
- 5 sites in United States
- Volunteers
- 12 people
- Sponsor
- Boehringer Ingelheim
Low Back Pain
Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects
The purpose of the study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-experienced subjects, with moderate to severe chronic low back pain (CLBP), who require continuous…
- Trial name
- NCT01675167
- Testing
- Buprenorphine
- Where
- 66 sites in United States
- Volunteers
- 815 people
- Sponsor
- BioDelivery Sciences International
Pain, Pharmacokinetics
Clinical Study in Healthy Men to Investigate the Uptake of Buprenorphine and Its Elimination From the Body After Dermal Application as Patches for 96 Hours and for 72 Hours
The purpose of the study was to investigate the pharmacokinetics (i.e. the uptake, distribution and elimination from the body) of dermally applied buprenorphine during and after different application periods, i.e., a 96-hour and…
- Trial name
- NCT03770234
- Testing
- Transtec 35 µg/hour transdermal patch
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Opioid Use Disorder
Reward-Based Recovery Outcomes Management for Opioid Use Disorder
A randomized pilot study assessing feasibility, acceptability, and preliminary effectiveness of a reward-based recovery management platform (PROCare) designed to enhance participation in outcomes monitoring, engagement in…
- Trial name
- NCT04669249
- Testing
- PROCare
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Medical Decision Logic, Inc.