Clinical trials: Opioid-Related Disorders
Opioid-related Disorders, Opioid Addiction
ER/LA Opioid Analgesics - Surveillance Monitoring of State Medical Examiner Databases
In April 2011, the U.S. Food and Drug Administration (FDA) determined that a class-wide risk evaluation and mitigation strategy (REMS) for all extended-release (ER) and long-acting (LA) opioid medications was necessary to support…
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02897414
- Testing
- Surveillance of state medical examiner databases
- Volunteers
- 13,015 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Opioid-use Disorder, Opioid Dependence
Comparing Home, Office, and Telehealth Induction for Medication Assisted Treatment for Opioid Use Disorder
HOMER is a national study comparing three methods of induction for Medication Assisted Treatment (MAT) for Opioid Use Disorder (OUD); home versus office versus telehealth-based inductions.
- Trial name
- HOMER (NCT04664062)
- Testing
- Medication Assisted Treatment
- Where
- 2 sites in United States
- Volunteers
- 303 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Access to Primary Care
Access to Primary Care for People With Opioid Use Disorder
Background: Access to high quality primary care is essential for health, particularly for vulnerable populations. Research indicates, however, that people with opioid use disorder (OUD), are less likely than others to have a…
- Trial name
- NCT05484609
- Testing
- OUD scenario, Diabetes scenario
- Where
- Canada
- Volunteers
- 383 people, healthy volunteers welcome
- Sponsor
- Women's College Hospital
Opioid-Related Disorders, Substance-Related Disorders
Evaluation of L-alpha-acetylmethadol (LAAM) in Methadone Patients - 5
The purpose of this study is to determine the pharmacokinetics of L-alpha-acetylmethadol (LAAM) in adults transferred from methadone maintenance treatment for opiate dependence.
- Trial name
- NCT00000356
- Testing
- LAAM
- Where
- United States
- Sponsor
- National Institute on Drug Abuse (NIDA)
Substance Use Disorders, Recidivism
Preventing OUD in Justice-Involved Youth
The United States is experiencing an opioid epidemic. Sadly, opioid-related fatalities are on the rise, causing profound emotional, financial, and cultural impacts.
- Trial name
- POST (NCT04901312)
- Testing
- Adolescent Community Reinforcement Approach, Assertive Continuing Care, Trauma Affect Regulation Guide for Education and Therapy
- Where
- United States
- Volunteers
- 215 people
- Sponsor
- Seattle Children's Hospital
Opioid Addiction, Opioid Abuse, Continuous Use
Healthy Adult Male Facial Skin Surface Lipid Pheromone p.o. to Treat Opioid Addiction
Healthy adult human male facial skin surface lipid liquid pheromone given by mouth to opioid addicts cures them without any withdrawal symptoms whatsoever 250mg on chewing gum vehicle by mouth.
- Conditions
- Opioid Addiction, Opioid Abuse, Continuous Use, Opioid Use, Opioid-Related Disorders
- Trial name
- NCT03394911
- Testing
- 250mg healthy adult male facial skin surface lipid liquid pheromone
- Volunteers
- 500 people
- Sponsor
- Bubba Nicholson
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
Neonatal Abstinence Syndrome
The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program
Neonatal Abstinence Syndrome (NAS), is a common and costly problem in Alberta that affects approximately 250 babies per year exposed to drugs during pregnancy. Unfortunately, this has become more common in the last 10 years.
- Trial name
- NASCENT (NCT05226624)
- Testing
- Rooming-in care, Baseline standard of care
- Where
- Canada
- Volunteers
- 240 people
- Sponsor
- University of Alberta
Medication Abuse, Harm Reduction
Evaluation of Clinical Decision Support in Opioid Tapering
The 2022 Center for Disease Control and Prevention (CDC) clinical practice guideline for prescribing opioids for pain recommends that when tapering a patient's opioid dose, doses should be decreased at a slow rate to reduce the…
- Conditions
- Medication Abuse, Harm Reduction, Opioid Use Disorder, Opioid Prescribing
- Trial name
- NCT06527079
- Testing
- Observational study without a prospective intervention
- Volunteers
- 200,000 people
- Sponsor
- University of Colorado, Denver
Opioid Withdrawal (Disorder), Opioid Use Disorder
A Pharmacokinetic, Safety, and Tolerability Study of LUCEMYRA in the Treatment of Opioid Withdrawal Management in Adolescent Subjects
The goal of this clinical study is to evaluate the pharmacokinetic (PK), safety, and tolerability of LUCEMYRA in adolescents age ≥12 to <18 years old abruptly discontinuing opioid use.
- Trial name
- NCT06711640
- Testing
- LUCEMYRA (lofexidine) tablets
- Where
- United States
- Sponsor
- USWM, LLC (dba US WorldMeds)
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.
Heroin Dependence, Morphine Dependence
Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate Detoxification - 1
The purpose of this study is to assess buprenorphine/naloxone versus clonidine for inpatient opiate detoxification.
- Conditions
- Heroin Dependence, Morphine Dependence, Substance Withdrawal Syndrome
- Trial name
- NCT00032955
- Testing
- Buprenorphine/naloxone
- Where
- 6 sites in United States
- Volunteers
- 163 people
- Sponsor
- University of California, Los Angeles
Opioid Use, Traumatic Injury
Opioid Use After Traumatic Injury in Adolescents
Currently, 1 in 8 adolescents continue to receive prescription opioids a year or more after injury. By longitudinally surveying patients, we can identify risk factors and pathways to nonmedical opioid use.
- Conditions
- Opioid Use, Traumatic Injury, Adolescent Behavior, Substance Abuse Disorder
- Trial name
- NCT03628846
- Where
- United States
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Indiana University
Opioid-Related Disorders, Opiate Addiction
Study to Validate Coded Medical Terms Used to Identify Opioid-Related Overdose in Databases Used for PMR Study 1B
The purpose of this study is to determine reliability of codes and data from electronic medical records to predict and measure overdose and death in patients prescribed opioid analgesics.
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02667197
- Testing
- Algorithm to determine overdose from opioid abuse
- Volunteers
- 2,701 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Opioid-related Disorders, Opioid Addiction
Surveillance Monitoring of Opioid Abuse in Poison and Drug Treatment Centers
To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics.
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02871232
- Testing
- Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion
- Volunteers
- 26,500 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Substance Withdrawal Syndrome, Critical Illness
Opioid Withdrawal Symptoms in Critically Ill Patients
Most critically ill patients encounter pain and distress from acute illness, medical procedures and devices as well as routine care in the intensive care units (ICU).
- Trial name
- NCT03374722
- Testing
- Opioids
- Where
- Thailand
- Volunteers
- 55 people
- Sponsor
- Mahidol University
Opioid-Related Disorders, Substance-Related Disorders
Effects of Combined Alcohol and Nitrous Oxide Intake - 15
The purpose of this study is to determine the effects of combined alcohol and nitrous oxide intake on mood, psychomotor performance, and the pain response in healthy volunteers.
- Trial name
- NCT00000263
- Testing
- 30% Nitrous oxide, 0.25 g/Kg ethanol, 0.5 g/KG ethanol
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Neonatal Abstinence Syndrome
Buprenorphine Dose Adjustments and Gestational Age
In this retrospective cohort study, we plan to examine the relationship between buprenorphine dose adjustments, gestational age, urine buprenorphine levels and the rate of neonatal abstinence syndrome in opioid-maintained…
- Trial name
- NCT03028883
- Testing
- Dose adjustments
- Volunteers
- 40 people
- Sponsor
- St. Louis University
Opioid-use Disorder
Feasibility of Pediatric Emergency Department-Initiated Treatment for Adolescents With Opioid Use Disorder
ED-initiated buprenorphine with brief intervention and facilitated referral to treatment has been shown to be highly successful in increasing treatment engagement rates and reducing opioid use among adults.
- Trial name
- PEDsTREATOUD (NCT04737603)
- Testing
- ED-Initiated treatment with buprenorphine / naloxone
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of California, Davis
Pain, Pain, Acute
Assessing Opioid Care Practices Using CPV Patient Simulation Modules
This study will test the quality of opioid-related physician care decisions using a patient-simulation based measurement and feedback approach that combines multiple-choice care decisions with real-time, personalized scoring and…
- Conditions
- Pain, Pain, Acute, Pain, Chronic, Pain, Neuropathic
- Trial name
- NCT04080037
- Testing
- Quality IQ Patient Simulations
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Qure Healthcare, LLC