Clinical trials: Opioid Related Disorders
Pregnancy Related, Substance Use
The Impact of Opioid and Cannabis Exposure on Fetal Growth
Individually, both opioid and cannabis exposure during pregnancy are associated with changes in fetal growth. The extent to which opioid and cannabis exposure affect fetal growth is unknown.
- Conditions
- Pregnancy Related, Substance Use, Fetal Growth Retardation, Placenta Diseases
- Trial name
- IMPACT (NCT05899101)
- Where
- 5 sites in Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Dr. Laura Gaudet
Neonatal Abstinence Syndrome
tAN to Mitigate Withdrawal Behaviors in Neonates
This first in-human-neonates, open-label pilot trial is designed to determine whether use of tAN in newborns with NOWS receiving oral morphine allows for faster weaning of morphine and decrease morphine use altogether.
- Trial name
- NCT04588519
- Testing
- Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Spark Biomedical, Inc.
Opioid-Induced Constipation (OIC)
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive…
- Trial name
- NCT05588323
- Testing
- Naldemedine
- Where
- 16 sites in Albania, Armenia and 6 more
- Volunteers
- 24 people
- Sponsor
- Shionogi
Opioid-Related Disorders
Neurobiology of Opioid Dependence: 5 - 5
The purpose of this study is to determine the effect of acute naltrexone pretreatment on the response to yohimbine in healthy volunteers.
- Trial name
- NCT00000196
- Testing
- Naltrexone
- Where
- United States
- Sponsor
- Yale University
Surgery, Opioid Use
Increasing Implementation of Post-Operative Opioid Prescribing Guidelines
The objective of this research study is to evaluate the effect of a quality improvement initiative carried out by a health system opioid stewardship task force aiming to increase clinician post-operative prescribing adherence…
- Conditions
- Surgery, Opioid Use, Opioid Misuse, Prescription Opioid Misuse
- Trial name
- NCT05358522
- Testing
- Opioid Prescribing Report Cards
- Where
- United States
- Volunteers
- 26,562 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Drug Use, Substance Use
Organization-level Youth Engagement Approach for Substance Misuse Prevention
This study will consist of a small pilot Randomized Controlled Trial (RCT). Four prevention organizations will be randomized either to include Youth Engagement in prevention efforts (treatment) or not (control).
- Conditions
- Drug Use, Substance Use, Opioid Use, Substance Misuse
- Trial name
- NCT05736211
- Testing
- Organization-level Youth Engagement prevention strategy
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
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
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
Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome
Cerebral Physiology of NOWS
This study will use a new device to measure blood flow and oxygen levels in the brains of newborn infants who have had exposure to opioid medications in the womb, compared to newborns who have not had any exposure.
- Conditions
- Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome, Opioid Use Disorder, Intrauterine Exposure
- Trial name
- NIRS for NOWS (NCT07610746)
- Testing
- FD-NIRS and DCS
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Indiana University
Opioid Prescribing, Prescription Drug Misuse
E-mails to Nudge Safer and Better-Informed Prescribing of Risky Drugs
This study will test e-mails to encourage engagement with the Minnesota prescription monitoring program (PMP/PDMP) and will evaluate the effect of these e-mails on PMP/PDMP use and controlled substance prescribing.
- Trial name
- NCT06443385
- Testing
- PDMP Legal Mandate E-mail, PDMP Clinical Benefit E-mail
- Where
- United States
- Volunteers
- 7,872 people, healthy volunteers welcome
- Sponsor
- Columbia University
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.
Child Behavior, Parent-Child Relations
A Scaleable Video Coaching Intervention for Opioid-using Mothers
This study will adapt and evaluate a novel, innovative, and highly scalable parenting intervention that employs video coaching to target responsive parenting, Filming Interactions to Nurture Development (FIND), among women who…
- Conditions
- Child Behavior, Parent-Child Relations, Substance Use, Substance Abuse
- Trial name
- NCT04749771
- Testing
- Filming Interactions to Nurture Development, The Healthy Toddler Program
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- University of Oregon
Cocaine-Related Disorders, Opioid-Related Disorders
Buprenorphine Maintenance for Cocaine Abusing Opioid Addicts - 1
The purpose of this study is to compare the clinical efficacy of maintenance on low and high doses of buprenorphine with methadone for cocaine abusing opiate addicts.
- Conditions
- Cocaine-Related Disorders, Opioid-Related Disorders, Substance-Related Disorders
- Trial name
- NCT00000216
- Testing
- Buprenorphine
- Where
- United States
- Sponsor
- Yale University
Opioid Use Disorder, Opioid Overdose
Health Insurance Instability and Mortality Among Patients Receiving Bup Tx for OUD
The goal of this multi-site observational cohort study is to link electronic health records (EHR) with novel data sources to examine insurance instability and its association with all-cause and overdose mortality in adult…
- Conditions
- Opioid Use Disorder, Opioid Overdose, Death
- Trial name
- NCT05944133
- Testing
- No intervention, observational retrospective study
- Where
- United States
- Volunteers
- 27,257 people
- Sponsor
- Kaiser Permanente
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.
HIV, Hepatitis C
Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC)
This study will evaluate the referral to harm reduction services (HRS) including syringe services, naloxone overdose prevention, substance use treatment referral, HIV, HCV, and STD testing and referral and linkage to care through…
- Conditions
- HIV, Hepatitis C, Opioid-use Disorder, Injection Drug Use
- Trial name
- ETHIC (NCT04427202)
- Testing
- Referral to harm reduction services
- Where
- 2 sites in United States
- Volunteers
- 306 people
- Sponsor
- University of Chicago
Opioid-Related Disorders, Drug Overdose
Prescribe to Save Lives
The U.S. is in the midst of an epidemic of opioid overdose deaths. The common use of opioids among persons living with HIV, along with their common use of benzodiazepines, has resulted in high rates of opioid overdose among this…
- Trial name
- PTSL (NCT03175640)
- Testing
- Implementation intervention
- Where
- 2 sites in United States
- Volunteers
- 294 people
- Sponsor
- Baystate Medical Center
Medication Abuse, Harm Reduction
Clinical Decision Support for Safety of Opioid Transitions
The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert designed to notify providers when an opioid prescription will result in a patient transitioning into a new phase of opioid therapy.
- Trial name
- NCT06527040
- Testing
- Opioid Transitions Clinical Decision Support (CDS)
- Where
- United States
- Volunteers
- 200,000 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
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
Medication Abuse, Harm Reduction
Clinical Decision Support to Increase Use of Medications for Opioid Use Disorder
The objective of this study is to evaluate the impact of clinical decision support (CDS) in the form of an alert to identify patients who may be at risk of opioid use disorder (OUD) and a clinical care pathway helping providers…
- Conditions
- Medication Abuse, Harm Reduction, Opioid Use Disorder, Supportive Care
- Trial name
- NCT06526286
- Testing
- Medications for Opioid Use Disorder Pathway Clinical Decision Support (CDS)
- Where
- United States
- Volunteers
- 200,000 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver