Clinical trials: Opioid Overdose
Opioid-Related Disorders, Drug Overdose
Repeated-dose Brief Intervention to Reduce Overdose and Risk Behaviors Among Naloxone Recipients
REBOOT is a pilot randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients (REBOOT).
- Trial name
- REBOOT (NCT02093559)
- Testing
- Brief counseling Intervention
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- San Francisco Department of Public Health
Respiratory Insufficiency, Opioid Overdose
Development of a Tracheal Sound Sensor
An observational study will be conducted in 20 hospitalized surgical patients routinely managed with opioids for anesthesia and post-operative pain control.
- Conditions
- Respiratory Insufficiency, Opioid Overdose, Hypoventilation
- Trial name
- NCT05506267
- Testing
- Trachea Sound Sensor (TSS)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Thomas Jefferson University
Opioid Use Disorder
Building Retention and Initiation Through Delivery of Peer-Guided Evidence-Based Practices
This study will provide longitudinal data for 6-months on a target sample of patients with Opioid Use Disorder (OUD) recruited from Prisma Health Mobile Health Clinics in South Carolina.
- Trial name
- BRIDGE-SC (NCT07541417)
- Testing
- Certified Peer Support Specialist Intervention
- Where
- United States
- Volunteers
- 750 people
- Sponsor
- Prisma Health-Upstate
Depression, Anxiety
More Individualized Care: Assessment and Recovery Through Engagement
The MI-CARE trial tests 12 months of telephone-based nurse care management for patients with depressive symptoms who take or have taken opioids at some time.
- Conditions
- Depression, Anxiety, Opioid-Related Disorders, Pain, Chronic
- Trial name
- MI-CARE (NCT05122676)
- Testing
- More Individualized Care: Assessment and Recovery through Engagement (MI-CARE)
- Where
- 2 sites in United States
- Volunteers
- 805 people
- Sponsor
- Kaiser Permanente
Opioid Overdose
Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults
This study will be a Phase 1, single-center, open-label, randomized cross-over study to evaluate the PK of a new AP003 device which delivers two sprays of 4 mg naloxone hydrochloride intranasally.
- Trial name
- NCT05377255
- Testing
- 16 mg naloxone AP003, 8 mg naloxone NARCAN Nasal Spray
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Opioid Use Disorder, Opioid Use Disorder, Moderate
TRTME: Improving Outpatient Initiation of Medication for Opioid Use Disorder Following Hospitalization
The primary objective of this study is to evaluate the ability of TRTME to increase initiation of MOUD outpatient treatment and MOUD knowledge in hospitalized patients with OUD deemed to be good candidates for MOUD by the UCMC…
- Conditions
- Opioid Use Disorder, Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe
- Trial name
- TRTME (NCT07780097)
- Testing
- TRTME
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- T. John Winhusen, PhD
Substance Use Disorders, Overdose
Emergency Medicine Peer Outreach Worker Engagement for Recovery
This is an observational, prospective case-control study evaluating the effects of an emergency department community health worker-peer recovery specialist program (PCHW), the Substance Misuse Assistance Response Team (SMART).
- Conditions
- Substance Use Disorders, Overdose, Opioid Use Disorder, Alcohol Use Disorder
- Trial name
- EMPOWER (NCT06320015)
- Testing
- Substance Misuse Assistance Response Team (SMART), Usual Care Group
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Substance Use, Mental Health Issue
Community Driven Substance Use Recovery for High Opioid Overdose Areas
The main goal of this current study is to develop and optimize methods for increasing access to, uptake of, and engagement in MAT (Medication Assisted Treatment) among communities of color.
- Conditions
- Substance Use, Mental Health Issue, Opioid Use, Medication Assisted Treatment
- Trial name
- IMANI U (NCT05260047)
- Testing
- IMANI, Telehealth MAT, Traditional MAT plus Referral and Linkage
- Where
- 8 sites in United States
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- Yale University
Medication Abuse, Harm Reduction
Clinical Decision Support to Improve System Naloxone Co-prescribing
The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert to facilitate the co-prescribing of naloxone, an opioid overdose reversal agent, with high-risk opioid prescriptions.
- Conditions
- Medication Abuse, Harm Reduction, Opioid Overdose, Opioid Prescribing
- Trial name
- NCT06271668
- Testing
- Naloxone Co-prescribing Clinical Decision Support (CDS)
- Where
- United States
- Volunteers
- 114,272 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Opioid Overdose
European Cohort Study of the Effectiveness of Take Home Naloxone
This study aims to assess the effectiveness of take-home naloxone (THN) to reverse opioid overdose when administered by lay persons in a real world setting.
- Trial name
- NalPORS (NCT05072249)
- Testing
- Naloxone
- Where
- 6 sites in Denmark, Sweden and 1 more
- Volunteers
- 6,000 people
- Sponsor
- King's College London
Overdose
SOONER Feasibility Study Protocol
Opioid Overdose Education and Naloxone Distribution programs (OEND) involve training and equipping people who are likely to be bystanders to opioid overdose to recognize and respond to opioid-related emergencies by activating…
- Trial name
- SOONER (NCT03821649)
- Testing
- SOONER Training and Naloxone Kit Kit, Community or Hospital-Based Training
- Where
- 4 sites in Canada
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Unity Health Toronto
Accidental Overdose of Opiate
Rapid Self-Testing to Prevent Fentanyl Overdose Among Young People Who Use Drugs
The research team will enroll 100 young adults who use cocaine, heroin, inject drugs, or purchase prescription medications on the illicit market in a pilot study to be known as the Rhode Island Young Adult Prescription and…
- Trial name
- RAPiDS2 (NCT03373825)
- Testing
- Take home rapid drug test
- Where
- United States
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Brown University
Opioid Overdose
Developing and Testing the Opioid Rapid Response System
This Phase I SBIR will develop and demonstrate the usability/feasibility of the Opioid Rapid Response System (OSSR) in order to reduce deaths and strain on emergency response systems from opioid overdoses.
- Trial name
- NCT04589676
- Testing
- Naloxone training
- Where
- 2 sites in United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Real Prevention, LLC
Drug Overdose, Opioid-Related Disorders
Development of an Algorithm That Predicts Hypoventilation Due to an Opioid Overdose
RTM Vital Signs, LLC is developing a miniature wearable tracheal sound sensor that communicates with a cell phone containing a machine-learning diagnostic algorithm designed to detect and predict the onset of mild, moderate, and…
- Trial name
- NCT03845699
- Testing
- Diagnostic algorithms that detects/predicts hypoventilation
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- RTM Vital Signs, LLC
Opioid Use Disorder, Pregnancy Related
Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD
The primary objective of this study is to evaluate the ability of TOME to increase Medication for Opioid Use Disorder (MOUD) and opioid-overdose knowledge in pregnant and postpartum persons.
- Conditions
- Opioid Use Disorder, Pregnancy Related, Substance Use, Drug Abuse
- Trial name
- TOME (NCT06262347)
- Testing
- Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME), Control
- Where
- 6 sites in United States
- Volunteers
- 131 people
- Sponsor
- T. John Winhusen, PhD
Opioid Overdose
Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens
This study is to compare the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given as a single dose intranasally (IN;into the nose), as a single dose in each nostril and…
- Trial name
- NCT05219669
- Testing
- Nalmefene Hydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Opiant Pharmaceuticals Inc
Substance Abuse, Decision Making, Shared
Data2Action Oregon Project: Supporting Data-driven Decision-Making for Substance Use Services, Policy, and Overdose Prevention
Oregon's decision makers (e.g., community service providers, public health, justice, advocacy groups, payers) are calling for comprehensive, current, and trusted data to inform how they allocate resources to improve substance use…
- Conditions
- Substance Abuse, Decision Making, Shared, Implementation Science, Decision Making
- Trial name
- D2A Oregon (NCT06852170)
- Testing
- Co-Design Sessions (CDS), Data products
- Where
- United States
- Volunteers
- 341 people, healthy volunteers welcome
- Sponsor
- Chestnut Health Systems
Opioid Overdose
Tailoring Overdose Education for Black Churches
Church-based interventions are culturally acceptable, reduce access barriers, and can be brought to scale in under-resourced communities.
- Trial name
- NCT05645016
- Testing
- COEST
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
Opioid Use, Cognitive Change
Cognitive Functioning in Opioid Use Disorder
This outpatient study is designed to examine the potential relationship between non-fatal opioid overdose and cognitive functioning.
- Conditions
- Opioid Use, Cognitive Change, Opioid-use Disorder
- Trial name
- NCT05001789
- Testing
- CogMed
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- New York State Psychiatric Institute
Opioid Overdose
UnityPhilly Response App for Overdose Reversal
The goal of this clinical trial is to discover if an overdose prevention app (UnityPhilly) can encourage citizen responders to respond and prevent opioid overdoses using the UnityPhilly app.
- Trial name
- NCT06466005
- Testing
- UnityPhilly app
- Where
- United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Drexel University