Clinical trials: Opioid-Induced Disorders
Opioid Dependence
An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects
This is an open label study in opioid dependent subjects maintained on a stabilized dose of Suboxone tablets or films. The purpose is to assess the safety and tolerability of BEMA Buprenorphine NX administered once daily for 12…
- Trial name
- NCT01666119
- Testing
- BEMA Buprenorphine NX films
- Where
- 10 sites in United States
- Volunteers
- 249 people
- Sponsor
- BioDelivery Sciences International
Opioid Use Disorder
A Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Participants With Opioid Use Disorder
The primary purpose of this study was to assess the safety and tolerability of multiple doses of buprenorphine/naloxone alone and buprenorphine/naloxone in combination with a single dose of ASP8062.
- Trial name
- NCT04447287
- Testing
- ASP8062, buprenorphine/naloxone
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Substance Abuse, Intravenous, HIV
Change the Cycle: An RCT to Prevent Injection Initiation
The study will test the efficacy of a hour long, one-on-one, active listening counseling session (called Change the Cycle or CTC) aimed at reducing behaviors among active people who inject drugs (PWID) that research has found to…
- Conditions
- Substance Abuse, Intravenous, HIV, Heroin Dependence, Opioid Dependence
- Trial name
- CTC (NCT02774954)
- Testing
- Change the Cycle
- Where
- 2 sites in United States
- Volunteers
- 979 people, healthy volunteers welcome
- Sponsor
- University of Southern California
Neoplasms, Constipation
Methylnaltrexone for Opioid-induced Constipation in Cancer Patients
The purpose of this study is to evaluate the efficacy of methylnaltrexone in relieving opioid-induced constipation in cancer patients at various stages of disease.
- Conditions
- Neoplasms, Constipation, Opioid-Related Disorders
- Trial name
- NCT01004393
- Testing
- Methylnaltrexone bromide
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Vermont
Pain, Cannabis
Enhancing Medication-based Analgesia in Humans
This is a single-group, within-subject, double-blind, double-dummy, placebo and active-controlled study evaluated whether the FDA-approved cannabinoid dronabinol (Marinol) would enhance analgesia, subjective reports, and…
- Conditions
- Pain, Cannabis, Opioid Use, Unspecified
- Trial name
- NCT02901275
- Testing
- Within-subject test of blinded study medications
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Post Traumatic Stress Disorder, Alcohol Abuse
Kappa Opioid Receptor Antagonism for the Tx of AUD and Comorbid PTSD
Objective: Evaluate the efficacy and physiological effects of sublingual buprenorphine (SL-BUP; Subutex) combined with extended-release injectable naltrexone (XR-NTX; Vivitrol) in the treatment alcohol use disorder of comorbid…
- Trial name
- NCT03852628
- Testing
- 2mg Buprenex and 380mg Vivitrol
- Where
- 2 sites in United States
- Volunteers
- 69 people
- Sponsor
- Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Stigma, Social, Opioid Use
SMART Trial: Intrapersonal and Interpersonal Stigma Reduction
The goal of this project is to develop a multicomponent stigma reduction intervention to address intrapersonal (individual) stigma regarding Opioid Use Disorder (OUD).
- Conditions
- Stigma, Social, Opioid Use, Opioid-use Disorder, Substance Use Disorders
- Trial name
- NCT04693416
- Testing
- Intrapersonal Stigma Reduction, Interpersonal Stigma Reduction
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- University of Tennessee
Opiate Substitution Treatment, Opioid-Related Disorders
Use of a GLP-1R Agonist to Treat Opioid Use Disorder
This research is being done to find out if liraglutide (brand name is Saxenda®) can safely and effectively reduce craving for opioids in patients with opioid use disorder, a primary factor contributing to early relapse.
- Trial name
- NCT04199728
- Testing
- Liraglutide Pen Injector
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Milton S. Hershey Medical Center
Substance-Related Disorders
Functional Magnetic Resonance Imaging of Opioid Withdrawal in Healthy Human Volunteers
Opioid medications are commonly used for pain relief. When given over time, physical dependence can occur. This results in unpleasant side effects--such as agitation and nausea--if opioid medications are suddenly stopped.
- Trial name
- NCT01006707
- Testing
- Ondansetron
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Stanford University
Opioid Use
Opioid Analgesic Reduction Study
The goal is to provide health care professionals, including dentists, with the best possible evidence for clinical decision making when deciding upon analgesics for acute post-surgical pain management, a double-blind, stratified…
- Trial name
- OARS (NCT04452344)
- Testing
- opioid-containing analgesic, two over-the-counter analgesics
- Where
- 5 sites in United States
- Volunteers
- 1,815 people, healthy volunteers welcome
- Sponsor
- Rutgers, The State University of New Jersey
Opiate Dependence
Employment-Based Depot Naltrexone Clinical Trial II
The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.
- Trial name
- NCT00684775
- Testing
- Work Plus Naltrexone Contingency
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Johns Hopkins University
Opioid Dependence
Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder
The overall aim of this R34 proposal is to examine the feasibility, acceptability, and short-term outcomes associated with an innovative service delivery model to increase adherence to extended-release naltrexone (XR-NTX) during…
- Trial name
- NCT03447743
- Testing
- XR-NTX community location
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Michele Staton
Chronic Pain, Opioid Induced Constipation
Naloxone SR Capsules in Patients With Opioid Induced Constipation
For many patients taking opioids for pain relief one of the most distressing side effects is constipation. Naloxone is effective in the reversal of the effects of opioids and is used following opioid overdose.
- Trial name
- NCT00984334
- Testing
- Naloxone SR 5 mg capsules, Naloxone SR 10 mg capsules, Naloxone SR 20mg capsules
- Where
- 8 sites in Germany, United Kingdom
- Volunteers
- 40 people
- Sponsor
- S.L.A. Pharma AG
Opiate Dependence
Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence
The purpose of this study is to evaluate a very low dose naltrexone-buprenorphine treatment to transfer opioid dependent individuals to extended release naltrexone injection (Vivitrol).
- Trial name
- BUP/NXT-VIVI (NCT01690546)
- Testing
- very low dose naltrexone, extended release naltrexone, buprenorphine/naloxone
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Paolo Mannelli
Opioid Use Disorder, Opioid-related Disorders
Open-Label Treatment Extension Study
Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who complete the RB-US-13-0003 study (NCT02510014) and for whom a new treatment venue has not been identified or arranged.
- Trial name
- NCT02896296
- Testing
- RBP-6000
- Where
- 29 sites in United States
- Volunteers
- 208 people
- Sponsor
- Indivior Inc.
Opioid-use Disorder
Cannabidiol on Reward- and Stress-related Neurocognitive Processes in Individuals With Opioid Use Disorder
The purpose of this study is to determine the impact of cannabidiol on reward- and stress-related neurocognitive processes among individuals with opioid use disorder on buprenorphine or methadone treatment.
- Trial name
- NCT04982029
- Testing
- Cannabidiol 100 MG/ML [Epidiolex]
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Brigham and Women's Hospital
Nalbuphine, Opioid Abuse
Oral Abuse Potential Study of Nalbuphine
The purpose of this study is to measure the effects of a drug called nalbuphine (an opioid drug) compared with the effects of hydromorphone (an opioid drug) and placebo (contains no active drug ingredients).
- Trial name
- NCT04018664
- Testing
- Nalbuphine HCl solution
- Where
- Canada
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Trevi Therapeutics
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
Stimulant Use & Co-occuring Opioid Use Disorders
Stimulant Oxytocin Study
This study will investigate the effects of intranasal administration of oxytocin, a social neuropeptide, on reducing stimulant use, enhancing therapeutic engagement, and susceptibility to stress-induced relapse in Veterans with…
- Trial name
- SOS (NCT03016598)
- Testing
- Intranasal oxytocin
- Where
- 3 sites in United States
- Volunteers
- 42 people
- Sponsor
- VA Office of Research and Development
Opioid Sensitivity, Individual Difference
A118G SNP and OPRM1 Gene Opioid-Mediated Effects in Humans
Within-subject, double-blind, placebo-controlled examination of opioid abuse potential in healthy individuals as a function of A118G SNP on the OPRM1 gene.
- Conditions
- Opioid Sensitivity, Individual Difference, Abuse Opioids
- Trial name
- NCT02360371
- Testing
- Within-subject test of blinded study medication
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University