Clinical trials: Buprenorphine
Opioid-use Disorder
Clinical Decision Support for Opioid Use Disorders in Medical Settings: Usability Testing in an EMR
The primary objective of this pilot study is to program an opioid use disorder (OUD) clinical decision support (CDS) tool for use in an electronic medical record (EMR) and obtain high primary care physician (PCP) usability and…
- Trial name
- COMPUTE (NCT03559179)
- Testing
- Opioid Wizard
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- HealthPartners Institute
Neonatal Abstinence Syndrome, Neonatal Opiate Withdrawal Syndrome
Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure
Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine.
- Trial name
- B-PHORE (NCT03608696)
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Thomas Jefferson University
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
Opioid Use Disorder (OUD)
HEALing Communities Study
This study will test the impact of implementing the Communities That Helping to End Addiction Long-term (HEAL) intervention on opioid overdose deaths within 67 highly affected communities with the goal of reducing opioid overdose…
- Trial name
- NCT04111939
- Testing
- Communities That HEAL, Wait-list control
- Where
- 4 sites in United States
- Volunteers
- 67 people
- Sponsor
- RTI International
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-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.
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.
Opioid-Related Disorders, NAS
MOms in REcovery (MORE) Study: Defining Optimal Care
Northern New England has among the highest rates of opioid dependence in the U.S. This region also has among the highest rates of opioid-related deaths in the U.S., with a disproportionate high rate among pregnant women with…
- Conditions
- Opioid-Related Disorders, NAS, Substance Use Disorders, Mental Health
- Trial name
- MORE (NCT04251208)
- Testing
- Observational Study
- Where
- 10 sites in United States
- Volunteers
- 2,510 people
- Sponsor
- Trustees of Dartmouth College
Opioid-use Disorder
PRimary Care Opioid Use Disorders Treatment (PROUD) Trial
Effective treatment for opioid use disorders (OUDs) requires medications. Two medications for treating OUDs-buprenorphine and injectable naltrexone-can be prescribed in primary care (PC).
- Trial name
- PROUD (NCT03407638)
- Testing
- PROUD Intervention
- Where
- 6 sites in United States
- Volunteers
- 377,373 people
- Sponsor
- Kaiser Permanente
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.
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-Related Disorders, Opiate Dependence
Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)
The purpose of this study is to evaluate the acceptability and safety of switching to Suboxone® (buprenorphine plus naloxone) and the effect of the switch on medication dispensing.
- Conditions
- Opioid-Related Disorders, Opiate Dependence, Drug Abuse
- Trial name
- NCT00725608
- Testing
- buprenorphine/naloxone
- Where
- Austria
- Volunteers
- 339 people
- Sponsor
- Indivior Inc.
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
Buprenorphine, Naloxone
Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)
The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic…
- Conditions
- Buprenorphine, Naloxone, Opiate-related Disorders, Opiate Dependence
- Trial name
- OPUS R (NCT00723697)
- Testing
- buprenorphine
- Volunteers
- 1,307 people
- Sponsor
- Indivior Inc.
Opioid Dependence
Dane County Drug Court Study for Addicted Offenders
The proposed work addresses critical health and public safety issues in the U.S. and in Wisconsin: the intersection of addiction and crime and the prevention of associated individual and public health complications.
- Trial name
- NCT01843751
- Testing
- buprenorphine/naloxone
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Wisconsin, Madison