Clinical trials: Buprenorphine
Opioid Dependence
Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low.
- Trial name
- PRO-807 (NCT00630201)
- Testing
- Probuphine (buprenorphine implant)
- Where
- 15 sites in United States
- Volunteers
- 62 people
- Sponsor
- Titan Pharmaceuticals
Opioid Dependence
The Safety of Using Buprenorphine With Naloxone in a Buccal Film to Initiate Treatment of Opioid Dependent Subjects
A randomized, double blind, active controlled study in approximately 40 opioid dependent subjects. Study duration is up to five days and includes a maximum of 3 days confinement in the clinic.
- Trial name
- NCT02516436
- Testing
- BEMA Buprenorphine NX, Buprenorphine
- Where
- 3 sites in United States
- Sponsor
- BioDelivery Sciences International
Low Back Pain
Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects
The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-naive subjects, with moderate to severe chronic low back pain (CLBP), who require continuous…
- Trial name
- NCT01633944
- Testing
- Buprenorphine
- Where
- 60 sites in United States
- Volunteers
- 752 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.
Hepatitis C Virus
A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123)
In this study, participants on methadone or buprenorphine/naloxone maintenance therapy will be given boceprevir. Blood samples will be taken at specified intervals to find out whether boceprevir affects the pharmacokinetics of…
- Trial name
- NCT01396005
- Testing
- boceprevir, methadone, buprenorphine/naloxone
- Volunteers
- 21 people
- Sponsor
- Merck Sharp & Dohme LLC
Opioid Dependency
Study of Probuphine in Patients With Opioid Dependence
Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low.
- Trial name
- PRO-809 (NCT00772785)
- Testing
- Probuphine (buprenorphine implant)
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Titan Pharmaceuticals
Pain
Bioequivalence and Adhesion Comparison of Buprenorphine Patches
To compare a 2nd generation Buprenorphine Transdermal System (BTDS) patch with a marketed 1st generation BTDS patch to confirm that the two are bioequivalent (deliver the same amount of drug) and that they equally both stick to…
- Trial name
- NCT02268422
- Testing
- Buprenorphine
- Where
- 2 sites in United Kingdom
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Mundipharma Research Limited
Chemotherapy Induced Mucositis, Mouth Pain
A Study to Characterize the Pharmacokinetics and Tolerability of Buprenorphine Patches in Children With Moderate to Severe Mouth Pain
The purpose of this study is to characterize the pharmacokinetics and tolerability of buprenorphine patches in children who require opioid pain relief for moderate to severe mouth pain.
- Trial name
- BUP1501 (NCT00947466)
- Testing
- Buprenorphine
- Where
- 2 sites in Denmark, United Kingdom
- Volunteers
- 25 people
- Sponsor
- Mundipharma Research Limited
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.
Pain
Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine Sublingual (under the tongue) Spray compared with placebo in participants with postoperative pain after bunionectomy.
- Trial name
- NCT02634788
- Testing
- Buprenorphine
- Where
- 4 sites in United States
- Volunteers
- 322 people
- Sponsor
- INSYS Therapeutics Inc
Opioid Use Disorder
Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder
This is a single-center, randomized, open-label, single-dose, parallel-group study which will enroll and randomize approximately 48 subjects (to achieve 36 completers) with opioid use disorder (OUD) who are seeking treatment for…
- Trial name
- NCT02559973
- Testing
- RBP-6000, SUBOXONE Sublingual Film
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Indivior 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
Dental Pain
Safety and Efficacy Study of NTC-510 to Treat Pain Following Dental Surgery of Third Molars
To evaluate the efficacy of a single dose NTC-510 or NTC-510A for dental pain following third molar extraction.
- Trial name
- NCT02161354
- Testing
- NTC-510 capsules, NTC-510A Capsules
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- NanoSHIFT LLC
Opioid Dependence
Probuphine Innovations for Clinical Effectiveness (PRINCE)
HITLAB will conduct a crossover study wherein participants will be asked to wear an actigraphy device continuously for 12 weeks.
- Trial name
- PRINCE (NCT02896660)
- Testing
- ActiGraph Link
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Healthcare Innovation Technology Lab
Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe
A Brief Negotiation Interview Chatbot to Improve Buprenorphine Engagement Among Justice-Involved Individuals
Primary Objective: Conduct pilot study to assess effects of brief negotiation interview (BNI) Chatbot among individuals involved in the Connecticut criminal justice system with opioid use disorder (OUD).
- Conditions
- Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe, Criminal Behavior
- Trial name
- BNICHAT (NCT04982627)
- Testing
- BNI Chatbot, OUD Education & Treatment Resources
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Center for Progressive Recovery, LLC
Moderate to Severe Opioid Use Disorder
INDV-6001 Multiple-Dose Pharmacokinetic Study
This is a multicentre, open-label, multiple dose study of INDV-6001 in adult participants with moderate or severe OUD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5).
- Trial name
- NCT06576843
- Testing
- INDV-6001, Suboxone, Sublocade
- Where
- 11 sites in United States
- Volunteers
- 123 people
- Sponsor
- Indivior 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.
Osteoarthritis
The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen…
- Trial name
- NCT00315848
- Testing
- Buprenorphine transdermal delivery system
- Where
- 10 sites in United States
- Volunteers
- 225 people
- Sponsor
- Purdue Pharma LP
Postoperative Pain
Safety of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Pain Following Orthopedic Surgery.
The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe pain after orthopedic surgery.
- Trial name
- NCT00315835
- Testing
- Buprenorphine transdermal delivery system
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Purdue Pharma LP
Cancer
Safety and Effectiveness of Transdermal Buprenorphine in Cancer Pain
Buprenorphine transdermal patch is newly available in Taiwan in June 2017, the trade name is Transtec, and the available dosages are 35 μg/h and 52.5 μg/h.
- Trial name
- SOOTHE (NCT04315831)
- Testing
- Transdermal Buprenorphine
- Where
- Taiwan
- Volunteers
- 83 people
- Sponsor
- Taiwan Mundipharma Pharmaceuticals Ltd.