Clinical trials: Buprenorphine
Moderate or Severe Opioid Use Disorder
A Multiple Dose Opioid Challenge Study
Multi-site, randomized, double-blind, repeat-dose Phase 2 study to evaluate the degree and duration of action of multiple doses of CAM2038 in blocking the effects of hydromorphone in patients with moderate or severe opioid use…
- Trial name
- NCT02611752
- Testing
- CAM2038
- Where
- 3 sites in United States
- Volunteers
- 47 people
- Sponsor
- Braeburn Pharmaceuticals
Pain
Comparison of Two Dosage Strengths of Transdermal Fentanyl Versus Transdermal Buprenorphine and Placebo in Acute Pain Models in Healthy Volunteers.
The primary objective of this pilot trial is to identify pain model(s) which allow(s) to compare and differentiate the analgesic effects between transdermal fentanyl 25µg/h, transdermal fentanyl 12µg/h and placebo in a dose…
- Trial name
- NCT00886002
- Testing
- Fentanyl; Buprenorphine; Naloxone
- Volunteers
- 20 people
- Sponsor
- Janssen-Cilag A.G., Switzerland
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.
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
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
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-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.
Healthy Volunteer Study
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
- Trial name
- NCT07314346
- Testing
- Buprenorphine/Naloxone + BEM/RZR, Methadone +BEM/RZR
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Healthy
Multiple Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations
The purpose of this study is to determine whether Transtec(R) PRO 70 µg/h and a new buprenorphine patch formulation lead to same plasma levels of buprenorphine after multiple dose application.
- Trial name
- NCT00387777
- Testing
- Patch with centrally acting analgesic, Transtec(R) PRO (buprenorphine)
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
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
Substance Withdrawal Syndrome, Opiate Addiction
Study to Evaluate the Exposures of Lofexidine and Its Major Metabolites in Subjects Seeking Buprenorphine Dose Reduction
The purpose of this study is to evaluate the relative exposures of lofexidine and its major metabolites in subjects seeking buprenorphine dose reduction.
- Conditions
- Substance Withdrawal Syndrome, Opiate Addiction, Opiate Dependence
- Trial name
- NCT02801357
- Testing
- lofexidine administration in subjects seeking buprenorphine dose reduction
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
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
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.
Renal Impairment
Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal Function
This study will evaluate the effect of various degrees of renal function on the pharmacokinetics and safety of ALKS 5461.
- Trial name
- NCT02508506
- Testing
- ALKS 5461
- Where
- 3 sites in United States
- Volunteers
- 22 people, healthy volunteers welcome
- 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.
Opioid Dependency
Study of Two Formulations of Buprenorphine HCl in Opioid-dependent Subjects on Buprenorphine Maintenance Therapy (Study P04451) (COMPLETED)
This is a multi-center, open-label, preference study of two sublingual formulations of buprenorphine HCl, in opioid-dependent patients on buprenorphine maintenance therapy.
- Trial name
- NCT01075971
- Testing
- Buprenorphine hydrochloride marketed sublingual tablet (Subutex), Buprenorphine hydrochloride fast dissolving tablet (FDT)
- Volunteers
- 52 people
- Sponsor
- Indivior Inc.
Osteoarthritis, Rheumatoid Arthritis
Evaluation Of Efficacy And Safety Of Norspan In Moderate To Severe Pain Due To Osteoarthritis, Rheumatoid Arthritis, Joint/Muscle Pain
The purpose of this study is to assess the efficacy of the buprenorphine transdermal patch (Norspan® or Sovenor® transdermal patch) in patients with chronic non-malignant pain of moderate to severe intensity due to…
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain, Joint Pain
- Trial name
- NCT01961271
- Testing
- Buprenorphine transdermal patch
- Where
- 16 sites in Hong Kong, Philippines and 1 more
- Volunteers
- 114 people
- Sponsor
- Mundipharma Pte Ltd.
Opiate Dependence
Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan
To determine whether Suboxone can be effectively used to treat Taiwanese ethnic subjects with opiate dependence.
- Trial name
- NCT00901875
- Testing
- Buprenorphine + naloxone (Suboxone)
- Where
- 8 sites in Taiwan
- Volunteers
- 127 people
- Sponsor
- Indivior Inc.
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
Opioid Use Disorder
Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)
This study will evaluate the safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection of VIVITROL.
- Trial name
- NCT02537574
- Testing
- NTX/BUP, NTX/PBO-B, PBO-N/PBO-B
- Where
- 20 sites in United States
- Volunteers
- 380 people
- Sponsor
- Alkermes, Inc.