Clinical trials: Opioid Related Disorders
Opioid Use Disorder
The O'Neil Long Acting Naltrexone Implant (OLANI) Pharmacokinetic (PK)/Safety Study in Healthy Volunteers
This study will examine the pharmacokinetic profile and safety of the O'Neil Long Acting Naltrexone Implant (OLANI) overtime in healthy volunteers. All participants will be treated in an open label manner.
- Trial name
- NCT03810495
- Testing
- naltrexone implant
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Go Medical Industries Pty Ltd
Opioid-use Disorder, Pain, Postoperative
BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control
This is a randomized, placebo controlled and natural-history controlled trial to investigate the effectiveness of NSS-2 BRIDGE® for postpartum women with AND without opioid use disorder (OUD).
- Trial name
- NCT04365465
- Testing
- NSS-2 Bridge, Inactive NSS-2 Bridge, Active control
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Grace Lim, MD, MS
Opiate Addiction
Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients
The purpose of this study is to determine if buprenorphine or methadone is better for the treatment of chronic pain among patients who have become addicted to prescription narcotics.
- Trial name
- NCT00879996
- Testing
- Methadone, Buprenorphine/naloxone
- Where
- 2 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- State University of New York at Buffalo
Opioid Abuse (Disorder)
Nudges and Incentives to Enhance the Opioid Treatment Workforce
This project seeks to examine a critical barrier to optimizing the health care workforce for the treatment of opioid use disorders.
- Trial name
- NCT03834025
- Testing
- Phase 1 Condition 1, Phase 1 Condition 2, Phase 1 Condition 3
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Opioid-use Disorder, Medication Assisted Treatment
Minds and Mentors Program (MiMP)- R61
The proposed research effort will: The purpose of this study is as follows: 1. Test the feasibility and acceptability of a twelve- week mindfulness based relapse prevention protocol in combination with peer mentoring in…
- Conditions
- Opioid-use Disorder, Medication Assisted Treatment, Substance Use Disorders
- Trial name
- MiMP (NCT04233671)
- Testing
- Mindfulness based relapse prevention and peer mentoring
- Where
- 2 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University of Alabama, Tuscaloosa
Opioid Abuse
Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone
The ability of pioglitazone (PIO) to alter the effects of opioids in humans has not been characterized in a controlled laboratory setting.
- Trial name
- NCT01395784
- Testing
- pioglitazone
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
Opioid Use Disorder
A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.
This is a Phase 1, single-centre, randomized, double-blind, placebo-controlled, 2 fixed sequences, multiple dose study in healthy male and/or female recreational opioid users.
- Trial name
- NCT05587998
- Testing
- Morphine, AZD4041
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted
The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused when they are crushed and snorted.
- Trial name
- NCT01775189
- Testing
- crushed ALO-02 30 mg/3.6 mg, crushed oxycodone IR 30 mg
- Where
- Canada
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
Opioid-Related Disorders
Abuse Potential of Intranasal VYCAVERT Tablets (Hydrocodone Bitartrate/Acetaminophen) in Recreational Opioid Users
To determine the relative abuse potential of VYCAVERT (hydrocodone bitartrate and acetaminophen) compared to GENERIC H/A (hydrocodone bitartrate and acetaminophen) when crushed and administered intranasally to non dependent…
- Trial name
- NCT01759446
- Testing
- Generic H/A taken first, Vycavert taken first, Generic H/A plus i taken first
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Acura Pharmaceuticals Inc.
Opioid Misuse
A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers
The primary hypothesis of this study is that at 3 months, there will be a higher proportion of intervention participants vs. control participants who report greater risk of harm from misuse of prescription opioids AND heroin.
- Trial name
- NCT04941950
- Testing
- PlaySmart, Video Game Control
- Where
- 15 sites in United States
- Volunteers
- 533 people, healthy volunteers welcome
- Sponsor
- Tyra Boomer
Opioid Use, Opioid Dependence
Efficiency And Quality In Post-Surgical Pain Therapy After Discharge
Following inpatient surgery, more than 80% of patients are prescribed opioids for use after discharge, yet up to 90% of patients report leftover opioids, and only 16% maximize non-opioid therapy.
- Conditions
- Opioid Use, Opioid Dependence, Opioid Misuse, Post-Surgical Complication
- Trial name
- EQUIPPED (NCT05221866)
- Testing
- Empowering Patient to Steer Their Pain Management After Surgery, Provider-facing Prescription Aid
- Where
- United States
- Volunteers
- 711 people, healthy volunteers welcome
- Sponsor
- University of Nebraska
HIV, AIDS
Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations
Specific Aim: To conduct a randomized, placebo-controlled trial of extended release-naltrexone (XR-NTX) among Human Immunodeficiency Virus (HIV) infected prisoners meeting Diagnostic Statistical Manual IV (DSM-IV) criteria for…
- Conditions
- HIV, AIDS, Opioid Dependence, Drug Dependence
- Trial name
- NewHope (NCT01246401)
- Testing
- Extended-Release Naltrexone
- Where
- 3 sites in United States
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Yale University
Opioid Overdose
Preventing Opioid Overdose Mortality in the United States
This study aims to conduct a randomized controlled trial of 105 syringe services programs (SSPs) throughout the United States to understand the effectiveness of a multifaceted, facilitation-based strategy at advancing naloxone…
- Trial name
- NCT03924505
- Testing
- Organize and Mobilize for Implementation Effectiveness, Dissemination
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- RTI International
Opioid-use Disorder, Medication Adherence
CoMBAT Opioid Use Disorder: A Combined Medication and Behavioral Activation Treatment for People Living With Opioid Use Disorder
This study seeks primarily to test, in a two-arm randomized controlled trial (RCT), the feasibility, acceptability, and preliminary efficacy of CoMBAT OUD, an intervention that integrates Behavioral Activation (BA) and substance…
- Conditions
- Opioid-use Disorder, Medication Adherence, Health Care Utilization
- Trial name
- CoMBAT_OUD (NCT04240093)
- Testing
- Behavioral Activation (BA) Therapy, Substance Abuse and Health Navigation Counseling, Medications for Opioid Use Disorder
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Brown University
Heroin Addiction
Methadone Maintenance for Prisoners
This five-year study examines the benefits of methadone maintenance treatment initiated in prison and continued in the community to male offenders who were previously, but not currently, heroin-dependent.
- Trial name
- MMP (NCT00378079)
- Testing
- Counseling Only, Counseling + Transfer, Counseling + Methadone
- Where
- United States
- Volunteers
- 211 people, healthy volunteers welcome
- Sponsor
- Friends Research Institute, Inc.
Opioid Abuse, Prescription Drug Abuse (Not Dependent)
Validation of a Community Pharmacy-Based Prescription Drug Monitoring Program Risk Screening Tool
The goal of the study is to validate a Prescription Drug Monitoring Program-based opioid risk metric to discriminate between low, moderate, and high-risk opioid use disorder.
- Trial name
- PHARMSCREEN (NCT03936985)
- Where
- 2 sites in United States
- Volunteers
- 1,464 people, healthy volunteers welcome
- Sponsor
- University of Utah
Substance Abuse, Chronic Pain
Physician Coaching to Reduce Opioid-related Harms
This project pilot tests an innovative clinical guideline translation and physician coaching model to promote adherence to evidence-based guidelines for the prescribing of opioid pain medications in primary care settings.
- Trial name
- NCT02433496
- Testing
- Physician coaching
- Where
- United States
- Volunteers
- 53,132 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Opioid-use Disorder
Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol
The study will enroll 30 opioid-dependent participants into an open-label pilot outpatient study of methods to facilitate induction and stabilization onto XR-NTX.
- Trial name
- NCT03113409
- Testing
- Buprenorphine, Naltrexone, Vivitrol
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
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