Clinical trials: Substance- Related Disorder
- Condition Substance- Related Disorder
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Constipation, Signs and Symptoms, Digestive
Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients
To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC) or at risk of OIC.
- Trial name
- NCT02099591
- Testing
- Naloxegol
- Where
- 16 sites in Denmark, Israel and 3 more
- Volunteers
- 61 people
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
Opioid Related Disorders, Opiate Addiction
Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers
A study will be performed to evaluate changes in prescribing behavior of prescribers of ER/LA opioids
- Conditions
- Opioid Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02920762
- Testing
- on-interventional study - retrospective database review
- Volunteers
- 5,575,834 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Neonatal Abstinence Syndrome
Study to Collect Data for Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Data Collection Process
Substance abuse during pregnancy is on the rise through both prescribed and illicit use of controlled substances, which has increased neonatal abstinence syndrome (NAS).
- Trial name
- NCT06303986
- Testing
- NeoMonki
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Rekovar Inc.
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.
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
Neurostimulation to Improve NOWS Outcomes
The objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.
- Trial name
- SPROUT (NCT05129020)
- Testing
- Sparrow Fledging Therapy System
- Where
- 3 sites in United States
- Volunteers
- 52 people
- Sponsor
- Spark Biomedical, Inc.
Prescription Opioid Misuse
Reducing High School Athletes' Prescription Opioids Misuse and Diversion Through the Student Athlete Wellness Portal
The goal of this study is to prevent prescription opioid misuse among high school athletes by developing, demonstrating the feasibility, and evaluating the outcomes of an innovative digital intervention.
- Trial name
- NCT05209191
- Testing
- Student Athlete Wellness Portal
- Where
- 5 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Real Prevention, LLC
Septic Shock, Acute Respiratory Distress Syndrome
CytOSorb TreatMent Of Critically Ill PatientS Registry
Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based…
- Conditions
- Septic Shock, Acute Respiratory Distress Syndrome, Trauma, Rhabdomyolysis
- Trial name
- COSMOS (NCT05146336)
- Testing
- CytoSorb
- Where
- 28 sites in Austria, Germany and 4 more
- Volunteers
- 3,000 people
- Sponsor
- CytoSorbents, Inc
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.
Adolescent Drinking, Adolescent Problem Behavior
Mindfulness Mobile App to Reduce Adolescent Substance Use
Substance-abusing youth - especially those who are involved in the juvenile justice system - are at higher risk than nonusers for mental health problems, including depression, conduct problems, personality disorders, suicidal…
- Trial name
- Qlarity (NCT04027075)
- Testing
- Qlarity app users
- Where
- United States
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
Substance Use, Stress
Automating Peer Learning to Reduce Alcohol Use and Related Deviant Behavior in Secondary School
Deviant peer affiliation is one of the most important predictors of alcohol use in adolescence. These affiliations arise when socially marginalized youth self-aggregate and reinforce alcohol use and other deviant activity (i.e.…
- Conditions
- Substance Use, Stress, Relation, Interpersonal, Bullying
- Trial name
- PeerLearning (NCT04478240)
- Testing
- PeerLearning.net
- Where
- United States
- Volunteers
- 924 people, healthy volunteers welcome
- Sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
Drug Addiction
Survey of Buprenorphine Use Among "Out of Care" Population in France (P04933)(COMPLETED)
This study was a survey of drug users who obtain buprenorphine from the black market and have used buprenorphine during the last month.
- Trial name
- NCT00756353
- Volunteers
- 600 people
- Sponsor
- Indivior Inc.
Opioid Induced Constipation
Naloxegol US PMR CV Safety.
The overall research goal for this study is to provide additional data to characterize the safety of naloxegol in patients aged 18 years and older who do not have a diagnosis of cancer and who are treated with opioids chronically
- Trial name
- NCT02813356
- Testing
- naloxegol, non-PAMORA
- Where
- 2 sites in United States
- Volunteers
- 8,800 people
- Sponsor
- Valinor Pharma LLC
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 Related Disorders, Opiate Addiction
Evaluation of Drug Utilization Patterns for Extended Release/Long Acting Opioids and Comparator Products
A drug utilization study will be performed to describe trends in the number of prescriptions and patients for class REMS ER/LA opioids and comparator products.
- Conditions
- Opioid Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02925806
- Testing
- Non-interventional study - retrospective database review
- Volunteers
- 5,575,834 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
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.
Baseline Epidemiologic Assessment
Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond Extended Release (BEAD-MB)
The main objectives of this study are to provide surveillance/descriptive data to (a) assess utilization of MorphaBond ER and selected comparators overall and by age group and census regions using nationally-projected quarterly…
- Trial name
- BEAD-MB (NCT04033094)
- Testing
- MorphaBond ER, Comparator Drug
- Where
- United States
- Volunteers
- 17,566 people
- Sponsor
- Daiichi Sankyo
Substance Use
Peer-to-peer Tobacco and ENDS Prevention
In Phase I, the REAL media Plus prototype will be developed and a usability test conducted among students and teachers. In Phase II a group randomized trial will be conducted among 27 high schools to evaluate the effects of REAL…
- Trial name
- PPSM (NCT03491865)
- Testing
- REAL media Plus curriculum
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Real Prevention, LLC
Alcohol Dependence
Post-Marketing Surveillance Study of Nalmefene Hydrochloride Hydrate in Patients with Alcohol Dependence
The purpose of this study is to investigate the safety and the prognosis after achieving reduced alcohol intake in patients with alcohol dependence who received treatment for the reduction of alcohol intake in the routine…
- Trial name
- NCT04107051
- Testing
- Nalmefene Hydrochloride Hydrate
- Where
- Japan
- Volunteers
- 533 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Neonatal Abstinence Syndrome
Donor Human Milk in Neonatal Abstinence Syndrome
This study is designed to develop pilot data on the acceptability and benefit of donor human milk for infants undergoing pharmacologic treatment for NAS.
- Trial name
- DHM&NAS (NCT02182973)
- Testing
- donor human milk
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neolac Inc dba Medolac Laboratories
Substance Abuse
Strengthening Families Program Online
This Phase II SBIR tests a newly developed web-based online parenting skills training and youth drug prevention program based on the evidenced-based "Strengthening Families Program." The study design involves a three-condition…
- Trial name
- SFPonline (NCT04214327)
- Testing
- Strengthening Families Program Online eLearning Game, SFP Home-use DVD, Wait-Listed Control
- Where
- United States
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Strengthening Families Program LLC