Clinical trials: Buprenorphine
Opioid Dependency
Re-Treatment Study of Probuphine in Opioid Addiction
Probuphine (buprenorphine implant) is an investigational implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence.
- Trial name
- NCT01262261
- Testing
- Probuphine (buprenorphine implant)
- Where
- 18 sites in United States
- Volunteers
- 85 people
- Sponsor
- Titan Pharmaceuticals
Pain
Clinical Pilot Study in Healthy Men to Characterize the Uptake of Buprenorphine Into and Its Elimination From the Body After Topical Application of Two New Forms of a Skin Patch in Comparison to a Reference Patch
This study is intended to produce information on the pharmacokinetic characteristics (uptake into and elimination from the body) of two new patch formulations of the analgesic buprenorphine as compared to the reference patch…
- Trial name
- NCT03785613
- Testing
- Test Product T1: Buprenorphine patch (9 mg), Test Product T2: Buprenorphine patch (3.8 mg), Reference Product R: Transtec patch (20 mg)
- Where
- Switzerland
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
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.
ECG Effects
The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) at Doses up to 80 Micrograms/Hour (mcg/hr) and Naltrexone on Electrocardiogram (ECG) Intervals in Healthy Volunteers
The purpose of this study is to evaluate the ECG effects of 10, 40, and 80 mcg/hr buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo in healthy male and female subjects.
- Trial name
- NCT01999114
- Testing
- Buprenorphine transdermal patch, Naltrexone tablet, Moxifloxacin tablet
- Where
- United States
- Volunteers
- 328 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
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
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
Low Back Pain, Osteoarthritis
Long-term Open-Label Safety Study to Evaluate EN3409
The purpose of the long-terms study is to evaluate the safety, tolerability, and analgesic efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended…
- Conditions
- Low Back Pain, Osteoarthritis, Neuropathic Pain
- Trial name
- NCT01755546
- Testing
- EN3409
- Where
- 57 sites in United States
- Volunteers
- 304 people
- Sponsor
- BioDelivery Sciences International
Pain, Low Back Pain
Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain
The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment of chronic pain.
- Conditions
- Pain, Low Back Pain, Osteoarthritis, Neuropathic Pain
- Trial name
- NCT01298765
- Testing
- BEMA Buprenorphine
- Where
- 26 sites in United States
- Volunteers
- 302 people
- Sponsor
- BioDelivery Sciences International
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, Opioid-related Disorders
Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder
A multi-center, open-label, long-term safety study in which approximately 600 subjects diagnosed with opioid use disorder will be enrolled.
- Trial name
- NCT02510014
- Testing
- SUBOXONE sublingual film, RBP-6000
- Where
- 42 sites in United States
- Volunteers
- 775 people
- Sponsor
- Indivior Inc.
Opioid Related Disorder
Multiple Dose Pharmacokinetics Depot Buprenorphine in Opioid-Dependent Subjects
This is an open-label study in treatment seeking opioid-dependent subjects for safety, tolerability, pharmacokinetics (PK), efficacy markers, and opioid receptor availability of subcutaneous injections of depot buprenorphine…
- Trial name
- NCT01738503
- Testing
- RBP-6000, Subutex
- Where
- United States
- Volunteers
- 124 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-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
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)
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
Post-operative Pain
Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
This is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group, placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of Buprenorphine Sublingual (under the tongue) Spray…
- Trial name
- NCT02310581
- Testing
- Buprenorphine Sublingual Spray
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- INSYS Therapeutics Inc
Infection, Human Immunodeficiency Virus
A Study to Assess the Drug-drug Interaction of BMS 663068 With Methadone and Also With Buprenorphine/Naloxone
The study is being conducted to assess the effect of multiple doses of BMS-663068 on the exposure of methadone in subjects on a stable dose of methadone, and the exposure of buprenorphine and norbuprenorphine in subjects on a…
- Trial name
- NCT02666001
- Testing
- BMS-663068, Methadone, Buprenorphine and Norbuprenorphine
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- ViiV Healthcare
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
Opiate Dependence, Drug Dependence
A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED)
The purpose of this study is to assess the acceptability and safety of Suboxone in heroin users as a replacement therapy for opioid dependency by comparing the clinical response of participants who are inducted directly onto…
- Conditions
- Opiate Dependence, Drug Dependence, Substance Dependence
- Trial name
- NCT00604188
- Testing
- Suboxone (SCH 000484), Subutex (SCH 028444)
- Volunteers
- 188 people
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
A Single-Dose Study of an Investigational Capsule Formulation of 2 mg/0.5 mg Buprenorphine/Naloxone
A single-dose pilot study of an investigational capsule formulation of 2 mg/.05 mg Buprenorphine/Naloxone. NIDA Contract No. HHSN271200577414C
- Trial name
- NCT00880841
- Testing
- Buprenorphine / Naloxone
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- NanoSHIFT LLC