Clinical trials: Buprenorphine
Pharmacokinetics and Pharmacodynamics of Sublingual Buprenorphine
Effects of Posaconazole and Voriconazole on the Pharmacokinetics and Pharmacodynamics of Sublingual Buprenorphine
Variability in drug response can be due to either pharmacokinetic or pharmacodynamic factors. The reasons why people differ in pharmacokinetics or pharmacodynamics are manifold and include, e.g., genetic factors, diseases, age…
- Trial name
- PosaBupre (NCT01367808)
- Testing
- vorikonazole, posakonazole
- Where
- Finland
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Turku University Hospital
Opiate Dependence, Substance-related Disorders
Prescription Opioid Addiction Treatment Study (POATS)
The purpose of this study is to determine whether treatment outcome for subjects dependent on prescription opioid analgesics can be improved by adding individual drug counseling to the prescription of buprenorphine/naloxone with…
- Conditions
- Opiate Dependence, Substance-related Disorders, Opioid-related Disorders
- Trial name
- NCT00316277
- Testing
- Standard Medical Management (SMM) of Prescription Opiate Abuse, Enhanced Medical Management (EMM) of Prescription Opiate Abuse
- Where
- 12 sites in United States
- Volunteers
- 653 people
- Sponsor
- Mclean Hospital
Opiate Addiction
Comparison of Buprenorphine/Naloxone With Naltrexone in Opioid Dependent Adolescents
This study is designed to determine the relative effectiveness of buprenorphine/naloxone (Suboxone) pharmacotherapy versus naltrexone pharmacotherapy for treatment retention, relapse prevention and opioid craving reduction among…
- Trial name
- NCT01015066
- Testing
- Buprenorphine/naloxone, Naltrexone
- Where
- United States
- Sponsor
- State University of New York at Buffalo
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.
Lactating Women on Select DOI, Breastfed Infants of Mothers on Select DOI
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Over half of women in the US who are breastfeeding their infants take prescription drugs. You are being asked to participate in this study because you are breastfeeding your infant and are currently taking, as part of your…
- Trial name
- NCT03511118
- Testing
- Tranexamic acid (TXA), labetalol, metformin
- Where
- 22 sites in United States, Canada
- Volunteers
- 1,600 people
- Sponsor
- Duke University
Opioid Use Disorder
Evaluating the Efficacy of a Digital Platform to Deliver Comprehensive Treatment for Opioid Use Disorder
Buprenorphine Evaluation and Telehealth Study (BEaTS) Comparison of retention in care between telehealth-based care and treatment as usual.
- Trial name
- BEaTS (NCT05529225)
- Where
- 2 sites in United States
- Volunteers
- 159 people
- Sponsor
- Boulder Care
Smoking Cessation
A Pilot Text Messaging Intervention to Reduce Smoking in Office-based Buprenorphine and Inpatient Detoxification Patients
The primary purpose of this study is to understand the feasibility of a text messaging intervention developed by the National Cancer Institute, known as Smokefreetxt, to improve smoking cessation among opiate and/or alcohol…
- Trial name
- NCT02665208
- Testing
- Treatment As Usual (TAU), Nicotine Replacement Therapies, Text Message Intervention (TMI)
- Where
- United States
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health
Neonatal Abstinence Syndrome
Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome
The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. In an open label Phase 1 trial sublingual buprenorphine was associated with a ~30% reduction length of treatment…
- Trial name
- NCT01452789
- Testing
- sublingual buprenorphine, oral morphine
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Thomas Jefferson University
Opioid Use Disorder, Fentanyl
Comparing Outpatient Treatment Retention Among Individuals Using Fentanyl Randomized to Low-dose and Direct-to-inject Buprenorphine Initiation
The goal of this pragmatic randomized controlled trial is to compare treatment outcomes of two strategies for initiating buprenorphine treatment (low-dose initiation and direct-to-inject) in adults with opioid use disorder (OUD)…
- Trial name
- COPILOT (NCT07469501)
- Testing
- Injectable buprenorphine, Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Francisco
Rotator Cuff Tears
Clinical Study on the Effect of Tizanidine on the Function and Pain of Patients After Shoulder Arthroscopy
The perspective, randomized controlled trial is to investigate and evaluate the effect of Tizanidine on the function and pain of patients with rotator cuff tear after shoulder arthroscopy;
- Trial name
- NCT05852093
- Testing
- Celecoxib+Buprenorphine Transdermal Patch, Celecoxib+Buprenorphine Transdermal Patch+Tizanidine
- Volunteers
- 100 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Drug Dependence
Extended Release Naltrexone for Opioid-Dependent Youth
The purpose of this study is to compare 6-month treatment outcomes for 15-21 year old opioid-dependent youth receiving extended release naltrexone (XR-NTX) v. Treatment as Usual (TAU).
- Trial name
- NCT01843023
- Testing
- Extended Release Naltrexone, Psychosocial Treatment, Buprenorphine
- Where
- 2 sites in United States
- Volunteers
- 288 people
- Sponsor
- Friends Research Institute, Inc.
Opioid Use Disorder, Pregnancy Related
Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy
This study will be a 12-month prospective, genotype-blinded longitudinal observational study with current standard of clinical care. This study will enroll 100 pregnant women with OUD at UPMC Hospitals with its high volumes.
- Trial name
- NCT05942313
- Testing
- Buprenorphine/ Methadone exposure
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Ilana Hull
Compliance, Chronic Pain
Evaluation of a Compliance Marker in Prescription Opioid Abusers With Chronic Pain
In a small, well-characterized sample of prescription opioid abusers (POAs) with chronic pain and on buprenorphine therapy, this study will investigate the utility and feasibility of two novel tracer compounds, and in combination…
- Trial name
- NCT02276989
- Testing
- acetazolamide, Quinine, Riboflavin
- Where
- United States
- Sponsor
- Georgetown University
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 Use Disorder, Opioid Use
HMP for Addictions Study
The goal of this clinical trial is to see whether the Healthy Minds Program for Addictions could be used to help veterans with moderate-severe opioid use disorder and post-traumatic stress disorder stay on buprenorphine…
- Conditions
- Opioid Use Disorder, Opioid Use, Buprenorphine Dependence
- Trial name
- NCT06063499
- Testing
- Healthy Minds Program for Addictions
- Sponsor
- University of Wisconsin, Madison
Suicidal Ideation, Major Depressive Disorder
Anti-suicidal Effects of Buprenorphine In Depressed Individuals
This study aims to examine the effect of low-dose buprenorphine as an add-on to treatment-as-usual for suicidal ideation in individuals with major depression, and investigate the functional brain activity related to its potential…
- Trial name
- NCT05427981
- Testing
- Belbuca Buccal Product
- Where
- United States
- Sponsor
- New York State Psychiatric Institute
Neonatal Abstinence Syndrome
Interest of Concentrations in Meconium of Buprenorphine and Methadone as a Prognostic Factor of NAS Outcome
The aim of this study is to characterize the interest of concentrations in meconium of drugs used for treatment of pregnant opioid-dependent woman as a prognostic factor of time, severity and duration of neonatal abstinence…
- Trial name
- SUBOPGEST (NCT03334981)
- Testing
- Concentrations in Meconium of Buprenorphine and Methadone
- Where
- France
- Volunteers
- 92 people
- Sponsor
- University Hospital, Caen
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
Opioid-use Disorder
Mobile Medication Adherence Platform for Buprenorphine-Naloxone During Treatment of Opioid Use Disorder: Phase I Study
The investigators will conduct a phase I study involving 41 participants selected randomly among patients prescribed buprenorphine-naloxone for opioid misuse as a feasibility trial of the study of the Pillsy device.
- Trial name
- MAP4BUP (NCT04656899)
- Testing
- Reminders messages to improve adherence.
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Washington State University
Opioid-use Disorder, Opioid Dependence
Young Houston Emergency Opioid Engagement System
The Houston Emergency Response Opioid Engagement System for Youths and Adolescents (Young HEROES) is a community-based research program integrating assertive outreach, medication for opioid use disorder (MOUD), behavioral…
- Conditions
- Opioid-use Disorder, Opioid Dependence, Opioid Overdose, Opioid Use
- Trial name
- YHEROES (NCT04811014)
- Testing
- Buprenorphine, Naloxone Drug Combination, Individual Counseling, Peer Recovery Support Services
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- The University of Texas Health Science Center, Houston